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1.
JAMA Ophthalmol ; 141(7): 658-666, 2023 07 01.
Article in English | MEDLINE | ID: mdl-37261816

ABSTRACT

Importance: Anti-vascular endothelial growth factor (VEGF) agents are currently the mainstay of treatment for diabetic retinopathy (DR). Although effective, data on their systemic safety remains inconclusive, particularly in high-risk patient groups. Objective: To explore the systemic safety of intravitreal anti-VEGF agents among patients with diabetes. Design, Setting, and Participants: This was a retrospective, longitudinal population-based analysis of the Corporate Data Warehouse, a large-scale database of patients within the US Veteran Health Affairs. All patients 18 years and older with type 2 diabetes who were seen at any Veterans Affairs health care facility in the US between January 1, 2011, and December 31, 2012, were identified. Data were then extracted on incident systemic adverse events among this patient cohort from January 1, 2013, to December 31, 2017. All individuals with diabetes who did and did not receive anti-VEGF injections were included. Patients with a history of prior systemic adverse events and those who received an intravitreal injection between January 1, 2011, and December 31, 2012, were excluded. Data were analyzed from October 2019 to March 2023. Exposure: Anti-VEGF injection. Main Outcomes and Measures: Proportion of patients with any incident systemic adverse event, acute myocardial infarction, cardiovascular disease, or kidney disease at 1-, 3-, and 5-year follow-up. Results: A total of 1 731 782 patients (mean [SD] age, 63.8 [12.3] years; 1 656 589 [95.7%] male) with type 2 diabetes were included. DR was present in 476 013 (27.5%), and 14 022 (0.8%) received anti-VEGF injections. Of the total number of patients with type 2 diabetes, 321 940 (18.6%) developed systemic adverse events between 2013 and 2017. The 5-year cumulative incidence of any systemic adverse event was 37.0% (5187/14 022) in the injection group vs 18.4% (316 753/1 717 760) in the noninjection group (P < .001). Anti-VEGF injections were independently associated with a higher likelihood of developing any systemic adverse event (odds ratio, 1.8; 95% CI, 1.7-1.9) when controlling for age, race, sex, ethnicity, tobacco use, severity of DR, Deyo-Charlson Comorbidity Index score, mean hemoglobin A1c, total number of injections, and statin use. Conclusion and Relevance: In this study, intravitreal anti-VEGF injections were independently associated with a higher likelihood of systemic adverse events among patients with diabetes.


Subject(s)
Diabetes Mellitus, Type 2 , Diabetic Retinopathy , Drug-Related Side Effects and Adverse Reactions , Humans , Male , Middle Aged , Female , Ranibizumab/adverse effects , Bevacizumab/adverse effects , Angiogenesis Inhibitors/therapeutic use , Vascular Endothelial Growth Factor A , Endothelial Growth Factors/therapeutic use , Intravitreal Injections , Diabetes Mellitus, Type 2/drug therapy , Retrospective Studies , Diabetic Retinopathy/diagnosis , Diabetic Retinopathy/drug therapy
2.
J Diabetes Metab Disord ; 21(1): 759-768, 2022 Jun.
Article in English | MEDLINE | ID: mdl-35582648

ABSTRACT

Purpose: There are limited studies on factors that impacted retina clinic patient outcomes during the COVID-19 pandemic. We aimed to evaluate visual and anatomic outcomes in patients with diabetic macular edema (DME) requiring anti-VEGF injections at the veterans' affairs tertiary care eye clinic in Houston, TX. Methods: Patient volume from April 2020 was compared to that of April 2019 to determine attendance changes. To evaluate outcomes, we reviewed patients with DME who had scheduled appointments during April 2020. We tracked changes in central foveal thickness (CFT) and Snellen visual acuity (VA) measurements. Patient outcomes were classified as poor (defined as worsening VA or CFT at follow-up) or good (no worsening of either at follow-up). Regression analysis identified characteristics associated with poor outcomes. Results: To prevent the spread of COVID-19, patients were called to reschedule clinic appointments. Attendance frequency decreased from 523 patients in April 2019 to 246 patients in April 2020. 134 patients met inclusion criteria (mean age of 64.7 ± 8.8 years). 19/134 of patients were seen on schedule, 89/134 had delayed appointments (average follow-up interval of 115.2 ± 50.0 days), and 26/134 were lost to follow-up. Patients with delayed appointments had higher odds of poor outcome at follow-up compared to patients seen on schedule (OR = 4.03, 95% CI: 1.14-16.92, p = 0.04). Patient's baseline visual acuity, macular thickness, comorbidities, and diabetic retinopathy severity, and demographics did not affect visual outcome at follow-up. Conclusions: On average, patients were rescheduled to a visit 2.4 months later than their usual visit. Over half these patients experienced worsening of vision or edema. This demonstrates that lapses in care result in worsening of DME. However, there is no clear association between baseline characteristics and risk of disease progression. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-022-01049-5.

3.
Graefes Arch Clin Exp Ophthalmol ; 259(11): 3371-3379, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34272610

ABSTRACT

PURPOSE: A history of gout, arthritis due to hyperuricemia, has been associated with decreased risk for neurodegenerative diseases such as Parkinson's disease. We performed a population-based case-control study in the US Department of Veterans Affairs (VA) medical centers nationwide to assess if gout or hyperuricemia is similarly associated with the ocular neurodegenerative condition glaucoma. METHODS: We used ICD-9 codes to identify a nationwide cohort of patients examined at VA healthcare eye clinics between 2000 and 2015 with a diagnosis of open-angle glaucoma (OAG) or of glaucoma suspect. We used incidence density matching to choose controls. We used multivariable logistic regression to examine associations between a history of gout and uric acid (UA) levels on relative risk of OAG or glaucoma suspect. RESULTS: There were 1,144,428 OAG or glaucoma suspect cases and 1,144,428 matched controls. Veterans with a history of gout had a small significant decreased risk of OAG compared to controls (ORadjusted(adj) = 0.985, 95% CI: 0.974-0.996). Treated gout was similarly associated with small decreased risk (ORadj = 0.963, 95% CI: 0.950-0.976). A small subset of patients (11.9% of cases and 13.2% of controls) had UA labs available; veterans with the highest median UA levels (> 7.29 mg/dL) did not have statistically significant differences in relative OAG risk (ORadj = 1.014, 95% CI: 0.991-1.036). CONCLUSION: Prospective research in other cohorts is needed to confirm our findings in veterans suggesting a history of gout is associated with a small decreased relative risk of glaucoma.


Subject(s)
Glaucoma, Open-Angle , Gout , Veterans , Case-Control Studies , Glaucoma, Open-Angle/diagnosis , Glaucoma, Open-Angle/epidemiology , Glaucoma, Open-Angle/etiology , Gout/diagnosis , Gout/epidemiology , Humans , Intraocular Pressure , Prospective Studies , Risk Factors
4.
Case Rep Oncol ; 14(1): 403-410, 2021.
Article in English | MEDLINE | ID: mdl-33790763

ABSTRACT

We report the clinical history and histopathological findings in a case of diffuse iris ring melanoma (DIM) and review the most recent literature and modern molecular genetics of this entity. An 85-year-old Hispanic man presented with severe unilateral glaucoma, managed at an outside institution for 2 years prior to presentation. Diffuse pigmentation was noted in the angle, on the intraocular lens implant, and in the vitreous without clear demonstration of a mass on ultrasound biomicroscopy. Workup for metastatic cutaneous melanoma was negative. Histopathological examination of the enucleated eye revealed a mixed cell type iris ring melanoma with diffuse intraocular involvement. Gene expression profiling (GEP) revealed a class 2 molecular signature indicating a very high risk for metastases. Unilateral glaucoma presenting with marked pigmentation in the anterior chamber angle should be managed as melanoma until proven otherwise. Iris ring melanomas are known to have an aggressive clinical course, and recent molecular analyses indicate that they are likely primarily GEP class 2 with a very poor prognosis, similar to the majority of ciliary body melanomas.

5.
Eye Contact Lens ; 46(6): 348-352, 2020 Nov.
Article in English | MEDLINE | ID: mdl-31794543

ABSTRACT

OBJECTIVES: To document outcomes associated with use of scleral contact lenses (SL) in the veteran population and analyze the medical and demographic factors that affect these outcomes, specifically those involved in contact lens discontinuation. METHODS: A retrospective study of consecutive patients first fitted with Jupiter Scleral lenses at the Michael E. DeBakey Veterans Affairs Medical Center between 2010 and 2018. The primary outcome was continuation of SL use at 1 year. Demographic factors and variables such as presence of comorbid diseases, improvement in visual acuity, and daily lens wear time were compared. Logistic regression analysis was used to determine which factors were associated with SL discontinuation. RESULTS: One hundred twenty patients with a mean age of 56.7±15.1 years were fitted with SL during the study period. The most common diagnosis was corneal ectasia (55.8%). Sixty-six (55.0%) patients had difficulty with wear, the most common being ocular irritation (20.0%) and mid-day fogging or bubbles (15.8%). Forty-one patients (34.2%) discontinued SL use with a median time from fitting to discontinuation of 5.2 months. The most common reason for SL discontinuation was difficulty with insertion and removal (53.7%). Comorbid neurologic disease had a statistically significant association with discontinuation (odds ratio 4.6, 95% confidence interval 1.3-17, P=0.022). There were statistically significant differences in mean visual acuity improvement (P=0.003) and daily wear time (P<0.001) but not age (P=0.70) between patients who continued and discontinued lens use. CONCLUSIONS: Scleral contact lenses are effective for treating a wide variety of ocular diseases and have positive outcomes in veterans. This study aids in understanding patient factors that affect outcomes of SL use in veterans. Further prospective studies are needed to make formal recommendations regarding candidate selection.


Subject(s)
Contact Lenses , Corneal Diseases , Veterans , Adult , Aged , Humans , Middle Aged , Prospective Studies , Prosthesis Fitting , Retrospective Studies , Sclera , Treatment Outcome
6.
Optom Vis Sci ; 95(12): 1114-1119, 2018 12.
Article in English | MEDLINE | ID: mdl-30451809

ABSTRACT

SIGNIFICANCE: Efforts to describe the relationship between pathological visual impairment and fall risk are typically confined to community dwellers. Among admitted patients, however, the associations are less understood. Fall risk assessment tools are used in some clinical settings, but most do not capture the suspected importance of ophthalmic pathologies in predicting the likelihood of an inpatient fall. PURPOSE: The purpose of this study was to determine the association between ophthalmic conditions and inpatient falls at the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC), where vision and ophthalmic conditions are not considered when assessing fall risk. METHODS: This is a population-based, retrospective case-control study of 805 patients admitted to the MEDVAMC in January 2014 who had also visited the MEDVAMC Eye Clinic within 1 year of admission. The patients' eye examinations, ophthalmic diagnoses, and other indicators of constitutive health were compared between 60 patients who experienced an inpatient fall ("cases") and 749 patients who did not ("controls"). Significant differences between the cases and the controls were determined using logistic regression models. RESULTS: Baseline demographics were similar among the two groups. Ophthalmic conditions associated with an increased incidence of inpatient falls included age-related macular degeneration (odds ratio, 3.9; 95% confidence interval, 1.5 to 9.9; P = .008) and a presenting visual acuity of worse than 20/40 in the better-seeing eye (odds ratio, 2.0; 95% confidence interval, 1.0 to 4.1; P = .04). Those without falls demonstrated a better mean presenting visual acuity in the better-seeing eye compared with those who fell (logMAR, 0.12 ± 0.23 vs. 0.28 ± 0.49, P < .001). CONCLUSIONS: In this population, age-related macular degeneration and poor presenting visual acuity in the better-seeing eye are associated with increased incidence of inpatient falls. An assessment of visual function and ophthalmic diagnoses may be warranted upon admission to the hospital for increased prevention of inpatient falls.


Subject(s)
Accidental Falls/statistics & numerical data , Inpatients/statistics & numerical data , Macular Degeneration/epidemiology , Veterans/statistics & numerical data , Vision Disorders/epidemiology , Visually Impaired Persons/statistics & numerical data , Aged , Aged, 80 and over , Case-Control Studies , Female , Hospitals, Veterans/statistics & numerical data , Humans , Incidence , Logistic Models , Male , Middle Aged , Odds Ratio , Retrospective Studies , Risk Assessment , United States/epidemiology , Visual Acuity/physiology
7.
J Cataract Refract Surg ; 42(3): 385-91, 2016 Mar.
Article in English | MEDLINE | ID: mdl-27063518

ABSTRACT

PURPOSE: To identify the clinical and operative factors predicting reoperation within 30 days of resident-performed cataract surgery and correlate them with 1-year visual outcomes. SETTING: Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA. DESIGN: Retrospective cohort study. METHODS: The study assessed patients who had resident-performed cataract surgery between 2005 and 2013 and required return to the operating room for a second surgery on the same eye within 30 days. Preoperative and intraoperative risk factors were assessed. Outcome measures included corrected distance visual acuity (CDVA) at 1 year. RESULTS: A review of 6644 resident-performed cataract surgeries showed that 54 eyes (0.85%) of 54 patients required a return to the operating room within 30 days. The reoperation rate was higher in the first half of the academic year (1.18%) than in the second half (0.55%) (P = .004). The mean CDVA 1 year postoperatively was 20/40, with a loss of lines of vision in 4 eyes. The mean operative time was 59.23 minutes ± 35.05 (SD). A longer intraoperative time was predictive of a worse visual outcome (P < .01). CONCLUSIONS: Despite the need for reoperation within 30 days, most patients achieved improved visual acuity. The reoperation rate was significantly lower in the second half of the academic year. Increased operation times correlated with worse visual acuity independent of other variables.


Subject(s)
Internship and Residency/standards , Intraoperative Complications , Ophthalmology/education , Phacoemulsification/standards , Postoperative Complications , Reoperation/statistics & numerical data , Cohort Studies , Female , Humans , Lens Implantation, Intraocular , Male , Operating Rooms/statistics & numerical data , Operative Time , Patient Outcome Assessment , Retrospective Studies , Visual Acuity/physiology
8.
J Glaucoma ; 25(8): 669-73, 2016 08.
Article in English | MEDLINE | ID: mdl-26950572

ABSTRACT

PURPOSE: To evaluate the outcomes of trabeculectomy performed in an ophthalmology training program. DESIGN: Retrospective study. PARTICIPANTS: A total of 160 patients undergoing trabeculectomy performed by a resident or fellow under attending supervision. MATERIALS AND METHODS: Trabeculectomy surgeries performed by a supervised resident or fellow surgeon between October 2000 and April 2010 were reviewed. Success was considered to be complete or partial if intraocular pressure (IOP)-lowering medications were not or were required to achieve IOP≤21 mm Hg, respectively. Failure was defined as IOP>21 mm Hg on 2 consecutive visits, loss of light perception vision, IOP≤5 on 2 consecutive visits with associated visual acuity loss of ≥2 lines, or need for surgical intervention. Trabeculectomy survival was determined using Kaplan-Meier analysis through 60 months of follow-up. MAIN OUTCOME MEASURES: Final IOP, success/failure rate. RESULTS: Complete success was achieved in 65 patients (41%). The average final IOP of this group was 9.1±3.7 mm Hg. Qualified success was achieved in 56 patients (35%). The average final IOP of this group was 11.5±6.4 mm Hg. At 60 months, the estimated cumulative probability of survival for complete and qualified successes was 28.9% and 63.7%, respectively. CONCLUSIONS: Among patients undergoing trabeculectomy by supervised residents or glaucoma fellows in a large Veterans Affairs Medical Center, IOP reduction was significant and similar to published studies. Trabeculectomy remains a successful intervention to lower IOP, with satisfactory success rates in the hands of trainee surgeons.


Subject(s)
Glaucoma/surgery , Internship and Residency/standards , Medical Staff, Hospital/standards , Trabeculectomy , Adult , Aged , Aged, 80 and over , Clinical Competence/standards , Female , Hospitals, Veterans/statistics & numerical data , Humans , Intraocular Pressure/physiology , Kaplan-Meier Estimate , Male , Middle Aged , Retrospective Studies , Trabeculectomy/education , Trabeculectomy/methods , Trabeculectomy/standards
9.
J Cataract Refract Surg ; 41(10): 2102-6, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26703285

ABSTRACT

PURPOSE: To evaluate risk factors and outcomes of unplanned, primary anterior chamber intraocular lenses (AC IOLs) placed by surgeons in training. SETTING: Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, USA. DESIGN: Retrospective case series. METHODS: Cataract surgeries performed primarily by a resident surgeon that resulted in an unplanned AC IOL were included. Cases that had concomitant retinal surgery were excluded. Preoperative data gathered included corrected distance visual acuity (CDVA), intraocular pressure (IOP), and ocular comorbid conditions. Operative times and complications requiring an AC IOL were assessed. Postoperative CDVA, IOP, corneal edema, persistent intraocular inflammation, macular edema, and need for additional surgery were analyzed for the first postoperative year. RESULTS: Twenty-two eyes were included. The mean preoperative CDVA was 1.24 logMAR ± 0.92 SD and the mean preoperative IOP was 17.55 ± 3.88 mm Hg. The mean operative time was 103 ± 30 minutes. The most common operative complications necessitating an AC IOL were 7 (32%) capsule tears with vitreous prolapse requiring anterior vitrectomy and 7 (32%) capsule tears, zonular dehiscence, and vitreous prolapse requiring anterior vitrectomy. By the first postoperative year, the mean visual acuity was 0.40 ± 0.58 logMAR and the IOP was 15.05 ± 6.01 mm Hg. The most common complications 1 year postoperatively included persistent macular edema (23%) and need for additional surgery (18%). CONCLUSION: This group of patients who received unplanned primary AC IOLs by surgeons in training had improved visual acuity and well-controlled IOP 1 year postoperatively. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.


Subject(s)
Anterior Chamber/surgery , Cataract Extraction , Education, Medical, Graduate/standards , Internship and Residency , Lens Implantation, Intraocular , Ophthalmology/education , Aged , Clinical Competence , Corneal Edema/physiopathology , Female , Humans , Inflammation/physiopathology , Intraocular Pressure/physiology , Intraoperative Complications , Macular Edema/physiopathology , Male , Postoperative Complications , Reoperation , Retrospective Studies , Risk Factors , Treatment Outcome , Visual Acuity/physiology
10.
Invest Ophthalmol Vis Sci ; 54(7): 4982-90, 2013 Jul 24.
Article in English | MEDLINE | ID: mdl-23766475

ABSTRACT

PURPOSE: To compare the effects of silver nanoparticles (AgNPs) and mitomycin C (MMC) on intraocular pressure (IOP) and external, histologic, and immunohistochemical bleb characteristics in a rabbit model of filtration surgery. METHODS: Filtration surgery with concurrent topical application of either AgNPs or MMC was performed on 14 pigmented Dutch Belted rabbits. IOP and bleb characteristics were compared on postoperative day 1 and at weeks 1 through 6. Hematoxylin and eosin staining and smooth muscle actin (SMA) immunohistochemistry were performed at postoperative week 6. RESULTS: Average IOP across all time points was reduced 5.8 and 3.8 mm Hg in AgNP- and MMC-treated eyes, respectively. At week 6, IOP was reduced 4.1 and 0.2 mm Hg in AgNP- and MMC-treated eyes, respectively. Blebs were smaller, thicker, and less ischemic in AgNP-treated eyes. AgNP-treated eyes showed less fibrosis and more stromal edema, suggesting increased filtration, and also had fewer SMA-positive myofibroblasts, suggesting reduced bleb contraction. AgNP-treated eyes showed more lymphocytes than MMC-treated eyes. There were few complications in both groups. CONCLUSIONS: In a rabbit model of filtration surgery, AgNPs are a reasonable alternative to MMC as adjunctive therapy. Compared to MMC, AgNPs result in an improved and sustained reduction of IOP and promote blebs with decreased fibrosis and ischemia as well as increased filtration despite a smaller overall size. This combination may offer an opportunity to promote long-term surgical IOP reduction with an improved complication profile.


Subject(s)
Anti-Infective Agents, Local/administration & dosage , Filtering Surgery/methods , Glaucoma/surgery , Metal Nanoparticles/administration & dosage , Silver/administration & dosage , Administration, Topical , Analysis of Variance , Animals , Antibiotics, Antineoplastic/administration & dosage , Antibiotics, Antineoplastic/adverse effects , Blister , Disease Models, Animal , Glaucoma/physiopathology , Intraocular Pressure/drug effects , Mitomycin/administration & dosage , Mitomycin/adverse effects , Rabbits
11.
J Glaucoma ; 22(1): 21-5, 2013 Jan.
Article in English | MEDLINE | ID: mdl-21623220

ABSTRACT

PURPOSE: To describe the outcome of surgical bleb revision for late-onset bleb leaks after trabeculectomy. PATIENTS AND METHODS: Appropriate cases were identified. Qualified and complete success required intraocular pressure of 21 mm Hg or less with and without glaucoma medication use, respectively. Bleb survival was determined using Kaplan-Meier survival analysis, and overall success rate was defined as qualified success at last follow-up. Preoperative and postoperative ocular parameters were compared using the signed-rank test. Age, sex, ethnicity, time between leak and revision, and surgeon type (attending vs. surgeons in training) were entered into a logistic regression analysis to assess the impact on surgical outcome. RESULTS: Seventy-eight eyes of 75 patients were included. The overall rate of successful bleb revision was 77%, and qualified and complete success at 24 months was 71% and 34%, respectively. Postoperative complications included early and late bleb leaks in 6% and 9% of the eyes, respectively; bleb-related infections in 4% of the eyes; and the need for additional glaucoma surgery in 10% of the eyes. There was no difference in preoperative and postoperative visual acuity (P=0.34) but there was an increase in intraocular pressure (P<0.0001) and the number of medications used (P<0.0001). The number of eyes that did not require glaucoma medication decreased (P=0.002). None of the variables examined had a significant impact on successful surgical outcome. CONCLUSION: Bleb revision showed a high success rate. About two-thirds of eyes required medication, 10% of eyes required additional glaucoma surgery, and there was a low risk for bleb-related infection following bleb revision.


Subject(s)
Surgical Wound Dehiscence/surgery , Surgically-Created Structures , Trabeculectomy/adverse effects , Aged , Antimetabolites/administration & dosage , Female , Glaucoma/surgery , Humans , Intraocular Pressure/physiology , Male , Reoperation , Surgical Wound Dehiscence/etiology , Treatment Outcome , Visual Acuity/physiology
12.
Geriatrics ; 64(7): 20-8, 2009 Jul.
Article in English | MEDLINE | ID: mdl-19586087

ABSTRACT

Chronic open-angle glaucoma is a leading cause of blindness and visual impairment in older adults. Optic nerve damage and the associated peripheral and subsequent central vision loss are irreversible, but early diagnosis and treatment will give patients the best chance to maintain functional vision and quality of life. Primary care physicians can assist with the diagnosis of glaucoma by making appropriate referrals for routine ophthalmic examinations, especially in patients with risk factors for glaucoma. Medication adherence and persistence may also be enhanced by discussing strategies to improve medication use and efficacy in the primary care setting. Recognition of adverse reactions from glaucoma medications and surgeries will allow proper management of these potentially serious conditions. Patients with advanced visual deficits can still benefit from treatment as well as low-vision and supportive care and should be referred for an ophthalmic evaluation. With an understanding of comprehensive glaucoma management, primary care physicians play an invaluable role in assisting their patients with effective and timely therapy that will result in improved outcomes.


Subject(s)
Blindness/prevention & control , Glaucoma, Open-Angle/diagnosis , Glaucoma, Open-Angle/drug therapy , Primary Health Care , Aged , Blindness/etiology , Diagnostic Techniques, Ophthalmological , Glaucoma, Open-Angle/complications , Humans , Referral and Consultation
13.
J Glaucoma ; 18(4): 293-300, 2009.
Article in English | MEDLINE | ID: mdl-19365194

ABSTRACT

PURPOSE: This study compared the intraocular pressure (IOP)-lowering efficacy of 2 fixed combination products, brinzolamide 1%/timolol 0.5% suspension (Azarga, Brinz/Tim) and dorzolamide 2%/timolol 0.5% solution (Dorz/Tim), in patients with open-angle glaucoma or ocular hypertension who required a change in therapy due to elevated IOP while receiving IOP-lowering medication. METHODS: This was a one-year, multicenter, randomized, double-masked, active-controlled, parallel-group trial of Brinz/Tim and Dorz/Tim. IOP assessments were taken at 8 and 10 AM at week 2 and months 3 and 9, and at 8 AM, 10 AM, and 4 PM at months 6 and 12. Primary efficacy was a noninferiority comparison of mean IOP at the three month 6 time points. RESULTS: Of the 437 patients enrolled, 220 dosed Brinz/Tim whereas 217 dosed Dorz/Tim twice daily. Brinz/Tim produced IOP-lowering efficacy comparable to Dorz/Tim, with the upper 95% confidence limits for the differences between groups within +1.5 mm Hg at all assessment times, including the month 6 primary efficacy time points, establishing noninferiority. Differences in means numerically favored Brinz/Tim at 9 of 12 study visits and times. The IOP reductions ranged from 7.2 to 9.2 mm Hg for Brinz/Tim and from 7.4 to 8.9 mm Hg for Dorz/Tim. Although a similar overall safety profile was observed between the 2 treatment groups, Brinz/Tim showed significantly less ocular irritation (2.7% vs. 10.6%; P=0.0009) than Dorz/Tim. CONCLUSIONS: Brinz/Tim suspension provides statistically significant and clinically relevant IOP-lowering efficacy that is noninferior to Dorz/Tim. Additionally, Brinz/Tim affords an ocular comfort advantage compared with Dorz/Tim.


Subject(s)
Adrenergic beta-Antagonists/therapeutic use , Carbonic Anhydrase Inhibitors/therapeutic use , Glaucoma, Open-Angle/drug therapy , Intraocular Pressure/drug effects , Sulfonamides/therapeutic use , Thiazines/therapeutic use , Thiophenes/therapeutic use , Timolol/therapeutic use , Administration, Topical , Adrenergic beta-Antagonists/adverse effects , Adult , Aged , Aged, 80 and over , Carbonic Anhydrase Inhibitors/adverse effects , Double-Blind Method , Drug Combinations , Female , Humans , Male , Middle Aged , Ocular Hypertension/drug therapy , Prospective Studies , Sulfonamides/adverse effects , Thiazines/adverse effects , Thiophenes/adverse effects , Timolol/adverse effects , Tonometry, Ocular , Treatment Outcome , Young Adult
14.
J Ocul Pharmacol Ther ; 25(2): 153-7, 2009 Apr.
Article in English | MEDLINE | ID: mdl-19284329

ABSTRACT

PURPOSE: To evaluate intraocular pressure (IOP) control and the ocular adverse effects resulting from a large-scale transition from latanoprost to travoprost among patients at a Veterans Affairs Medical Center (VAMC) Eye Clinic. METHODS: Retrospective chart review of patients transitioned from latanoprost to travoprost after a revision of the drug formulary used by the VAMC in Houston, Texas. IOP control after changing medications and the incidence of ocular adverse effects attributed to travoprost were the main outcomes measured. For patients who were using IOP-lowering medications bilaterally, the worse eye was used for all IOP analyses. Long-term retention in IOP control plus a cost-saving analysis were presented as a secondary assessment. RESULTS: Five hundred ninety-nine (599) patients with 1,041 treated eyes were evaluated. Mean IOP was 15.86 +/- 4.15 mmHg among patients using latanoprost prior to the prostaglandin analog transition. After transitioning to travoprost, the mean IOP was 15.78 +/- 4.38 mmHg. The mean within-eye change in IOP in the worse eye when transitioned from latanoprost to travoprost was -0.07 +/- 3.27 mmHg (P = 0.5914). Twenty-four (24) patients (4%) experienced an ocular adverse effect while using travoprost. In the long-term retention analysis at 1 year, mean change in IOP from the time of the original change to travoprost was +0.21 +/- 3.71 mmHg (P = 0.2683). CONCLUSIONS: The large-scale transition from latanoprost to travoprost maintained long-term IOP control. Only a small percentage of clinic patients experienced mild ocular adverse effects after being transitioned to the new prostaglandin analog.


Subject(s)
Antihypertensive Agents/administration & dosage , Cloprostenol/analogs & derivatives , Intraocular Pressure/drug effects , Prostaglandins F, Synthetic/administration & dosage , Prostaglandins, Synthetic/administration & dosage , Adult , Aged , Aged, 80 and over , Antihypertensive Agents/adverse effects , Cloprostenol/administration & dosage , Cloprostenol/adverse effects , Drug Administration Schedule , Female , Hospitals, Veterans , Humans , Hyperemia/chemically induced , Latanoprost , Male , Middle Aged , Ophthalmic Solutions , Outpatient Clinics, Hospital , Prostaglandins F, Synthetic/adverse effects , Prostaglandins, Synthetic/adverse effects , Retrospective Studies , Travoprost
15.
Am J Ophthalmol ; 140(1): 1-7, 2005 Jul.
Article in English | MEDLINE | ID: mdl-15990081

ABSTRACT

PURPOSE: To compare the safety and intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution (Trav/Tim) to its components travoprost 0.004% ophthalmic solution, TRAVATAN, (Trav) and timolol 0.5% ophthalmic solution (Tim) in patients with open-angle glaucoma or ocular hypertension. DESIGN: Randomized multicenter, double-masked, active-controlled, parallel group study. METHODS: Two hundred sixty-three patients with open-angle glaucoma or ocular hypertension were randomized to receive Trav/Tim once daily AM (and vehicle PM), Trav once daily PM (and vehicle AM), or Tim twice daily (AM and PM). Efficacy and safety were compared across treatment groups over 3 months. RESULTS: Trav/Tim produced a mean IOP decrease from baseline of 1.9 mm Hg to 3.3 mm Hg more than Tim, with a significant decrease in mean IOP at each of the nine study visits (P < or = .003). Trav/Tim decreased mean IOP by 0.9 mm Hg to 2.4 mm Hg more than Trav, with a significant decrease in mean IOP at seven of the nine study visits (P < or = .05). The adverse event profile for Trav/Tim was comparable to Trav or Tim alone. CONCLUSIONS: Over the 3 months of treatment, Trav/Tim produced clinically relevant IOP reductions in patients with open-angle glaucoma or ocular hypertension that were greater than those produced by either Trav or Tim alone. The clinical results that Trav/Tim was safe and well tolerated with an incidence of adverse events was comparable to the results of Trav or Tim alone. Trav/Tim provides both more effective IOP reduction than its components and the benefits of once-daily dosing.


Subject(s)
Antihypertensive Agents/therapeutic use , Cloprostenol/analogs & derivatives , Cloprostenol/therapeutic use , Glaucoma, Open-Angle/drug therapy , Intraocular Pressure/drug effects , Timolol/therapeutic use , Adult , Aged , Aged, 80 and over , Antihypertensive Agents/administration & dosage , Antihypertensive Agents/adverse effects , Blood Pressure/drug effects , Cloprostenol/administration & dosage , Cloprostenol/adverse effects , Double-Blind Method , Drug Combinations , Female , Heart Rate/drug effects , Humans , Male , Middle Aged , Ocular Hypertension/drug therapy , Ophthalmic Solutions/administration & dosage , Ophthalmic Solutions/adverse effects , Ophthalmic Solutions/therapeutic use , Safety , Timolol/administration & dosage , Timolol/adverse effects , Travoprost , Treatment Outcome
16.
Am J Ophthalmol ; 138(5): 744-8, 2004 Nov.
Article in English | MEDLINE | ID: mdl-15531308

ABSTRACT

OBJECTIVE: To determine normal central and paracentral corneal thickness measurements in the pediatric population and to determine if these measurements are consistent across different pediatric age groups and different racial groups. DESIGN: Prospective observational case series. METHODS: Pachymetry measurements were performed on 198 eyes of 108 children. The measurements were taken centrally as well as at four paracentral sites 3 mm from the corneal center at the 3, 6, 9, and 12 o'clock positions. The two-tailed t test was used for comparison of the continuous means for values of corneal thickness. Analysis of variance (ANOVA) was performed to determine differences among age and ethnic groups RESULTS: The mean central corneal thickness (CCT) was 549 +/- 46 microm. Paracentral corneal thickness mean values, as measured 3 mm from the corneal center, were as follows: superior, 575 +/- 52 microm; nasal, 568 +/- 50 microm; inferior, 568 +/- 51 microm; and temporal, 574 +/- 47 microm. The mean CCT values were significantly thinner than at each of the mean paracentral points (P < .05 for each comparison, paired t test). Paracentral corneal thickness measurements demonstrated no significant differences between locations (P > .05, variance analysis). The mean CCT +/- SD for each age group was as follows: 6 to 23 months, 538 +/- 40 microm; 2 to 4 years, 546 +/- 41 microm; 5 to 9 years, 566 +/- 48 microm; and 10 to 18 years, 554 +/- 35 microm (ANOVA P = .012). ANOVA performed on central pachymetry values demonstrated no significant differences among racial subgroups. CONCLUSIONS: Pediatric central and paracentral corneal thicknesses increase slowly over time and reach adult thicknesses at 5 to 9 years of age.


Subject(s)
Aging/physiology , Cornea/anatomy & histology , Adolescent , Anatomy, Cross-Sectional , Body Weights and Measures , Child , Child, Preschool , Diagnostic Techniques, Ophthalmological , Female , Humans , Infant , Male , Prospective Studies
17.
Arch Neurol ; 61(9): 1386-9, 2004 Sep.
Article in English | MEDLINE | ID: mdl-15364684

ABSTRACT

BACKGROUND: Participants enrolled in the Optic Neuritis Treatment Trial have been observed for more than a decade to assess the relationship between optic neuritis and the development of clinically definite multiple sclerosis. OBJECTIVE: To assess neurologic disability 10 to 12 years after an initial episode of optic neuritis. DESIGN: Longitudinal follow-up of a clinical trial. SETTING: Fourteen Optic Neuritis Treatment Trial clinical centers performed standardized neurologic examinations, including an assessment of neurologic disability. PARTICIPANTS: One hundred twenty-seven patients who had developed clinically definite multiple sclerosis. MAIN OUTCOME MEASURES: Functional Systems Scale and Expanded Disability Status Scale. RESULTS: The disability of most patients was mild, with 65% of patients having an Expanded Disability Status Scale score lower than 3.0. The degree of disability appeared to be unrelated to whether the baseline magnetic resonance imaging scan was lesion-free or showed lesions (P =.51). Among patients with baseline lesions, the degree of disability was unrelated to the number of lesions that were present on the scan (P =.14). Two patients died owing to severe multiple sclerosis, one of whom had no lesions revealed on the baseline scan. CONCLUSION: Most patients who develop clinically definite multiple sclerosis following an initial episode of optic neuritis will have a relatively benign course for at least 10 years.


Subject(s)
Disability Evaluation , Multiple Sclerosis/complications , Multiple Sclerosis/physiopathology , Optic Neuritis/complications , Adult , Brain/diagnostic imaging , Brain/pathology , Clinical Trials as Topic , Female , Follow-Up Studies , Humans , Magnetic Resonance Imaging , Male , Middle Aged , Multiple Sclerosis/diagnostic imaging , Optic Neuritis/diagnostic imaging , Optic Neuritis/pathology , Radiography
18.
J Glaucoma ; 13(5): 365-70, 2004 Oct.
Article in English | MEDLINE | ID: mdl-15354073

ABSTRACT

PURPOSE: To evaluate if aspirin use affects progression of primary open angle glaucoma (POAG). METHODS: A retrospective review of patients with uncontrolled glaucoma was performed. Incidence of aspirin use was noted by a one-time self-reporting survey. Controls were medically stable patients diagnosed with POAG. The primary outcome measure studied was a comparison of percentages of aspirin use in patients who have and have not undergone glaucoma filtering surgery (trabeculectomy). RESULTS: Forty-one percent (26/64) of the patients in the trabeculectomy group and 23% (17/74) of controls were using aspirin. Patients undergoing trabeculectomy were twice as likely to take aspirin (O.R., 2.29; 95% C.I., 1.10-4.79). Subgroup analyses demonstrated increased aspirin use in those operative patients who are current or former smokers (O.R., 3.71; 95% C.I., 1.10-12.56), have systemic hypertension (O.R., 3.30; 95% C.I., 1.02-22.58), or have joint disease (O.R., 4.60; 95% C.I., 1.34-15.82). CONCLUSION: A higher concurrence of aspirin use was observed in patients with POAG who required surgical management compared with patients having relatively medically stable glaucoma. This may be secondary to a higher rate of glaucoma surgery performed on patients with greater systemic illnesses, more of whom use aspirin.


Subject(s)
Aspirin/therapeutic use , Glaucoma, Open-Angle/physiopathology , Aged , Cardiovascular Diseases/complications , Cohort Studies , Disease Progression , Female , Glaucoma, Open-Angle/complications , Glaucoma, Open-Angle/surgery , Humans , Joint Diseases/complications , Male , Retrospective Studies , Trabeculectomy , Visual Fields
19.
Am J Ophthalmol ; 137(1): 77-83, 2004 Jan.
Article in English | MEDLINE | ID: mdl-14700647

ABSTRACT

PURPOSE: To assess visual function more than 10 years after an episode of optic neuritis in patients enrolled in the Optic Neuritis Treatment Trial. DESIGN: Longitudinal follow-up of a randomized clinical trial. METHODS: Vision testing included measures of visual acuity, contrast sensitivity, and visual field. Quality of life was assessed with the National Eye Institute Visual Function Questionnaire. RESULTS: Examinations were completed on 319 patients. In most patients, visual function test results in the eyes that experienced optic neuritis at study entry ("affected eyes") were normal or only slightly abnormal after 9.9 to 13.7 years. Visual acuity in the affected eyes was >or=20/20 in 74%, 20/25 to 20/40 in 18%, <20/40 to 20/200 in 5%, and <20/200 in 3%. On average, visual function was worse in patients with multiple sclerosis (MS) than in those without MS. Recurrent optic neuritis in either eye occurred in 35% of patients. Such attacks were more frequent in patients with MS (P <.001). The National Eye Institute Visual Function Questionnaire scores were lower when visual acuity was abnormal and when MS was present. CONCLUSIONS: Most patients retained good to excellent vision more than 10 years after an attack of optic neuritis. Recurrences were more frequent in patients with MS.


Subject(s)
Contrast Sensitivity/physiology , Glucocorticoids/therapeutic use , Optic Neuritis/drug therapy , Optic Neuritis/physiopathology , Visual Acuity/physiology , Visual Fields/physiology , Adolescent , Adult , Female , Follow-Up Studies , Health Status Indicators , Humans , Male , Middle Aged , Multiple Sclerosis/physiopathology , National Institutes of Health (U.S.)/standards , Quality of Life , Recurrence , Surveys and Questionnaires , United States , Vision Tests
20.
Arch Ophthalmol ; 121(7): 944-9, 2003 Jul.
Article in English | MEDLINE | ID: mdl-12860795

ABSTRACT

OBJECTIVE: To identify factors associated with a high and low risk of developing multiple sclerosis after an initial episode of optic neuritis. METHODS: Three hundred eighty-eight patients who experienced acute optic neuritis between July 1, 1988, and June 30, 1991, were followed up prospectively for the development of multiple sclerosis. Consenting patients were reassessed after 10 to 13 years. RESULTS: The 10-year risk of multiple sclerosis was 38% (95% confidence interval, 33%-43%). Patients (160) who had 1 or more typical lesions on the baseline magnetic resonance imaging (MRI) scan of the brain had a 56% risk; those with no lesions (191) had a 22% risk (P<.001, log rank test). Among the patients who had no lesions on MRI, male gender and optic disc swelling were associated with a lower risk of multiple sclerosis, as was the presence of the following atypical features for optic neuritis: no light perception vision; absence of pain; and ophthalmoscopic findings of severe optic disc edema, peripapillary hemorrhages, or retinal exudates. CONCLUSIONS: The 10-year risk of multiple sclerosis following an initial episode of acute optic neuritis is significantly higher if there is a single brain MRI lesion; higher numbers of lesions do not appreciably increase that risk. However, even when brain lesions are seen on MRI, more than 40% of the patients will not develop clinical multiple sclerosis after 10 years. In the absence of MRI lesions, certain demographic and clinical features seem to predict a very low likelihood of developing multiple sclerosis. This natural history information is a critical input for estimating a patient's 10-year multiple sclerosis risk and for weighing the benefit of initiating prophylactic treatment at the time of optic neuritis or other initial demyelinating events in the central nervous system.


Subject(s)
Multiple Sclerosis/epidemiology , Optic Neuritis/epidemiology , Acute Disease , Adolescent , Adult , Anti-Inflammatory Agents/therapeutic use , Brain/pathology , Cohort Studies , Female , Humans , Magnetic Resonance Imaging , Male , Methylprednisolone Hemisuccinate , Middle Aged , Multiple Sclerosis/diagnosis , Multiple Sclerosis/drug therapy , Optic Neuritis/diagnosis , Optic Neuritis/drug therapy , Prednisone , Prospective Studies , Risk Factors , Sex Factors , United States/epidemiology
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