2022 American College of Rheumatology Guideline for Vaccinations in Patients With Rheumatic and Musculoskeletal Diseases.

OBJECTIVE: To provide evidence-based recommendations on the use of vaccinations in children and adults with rheumatic and musculoskeletal diseases (RMDs). METHODS: This guideline follows American College of Rheumatology (ACR) policy guiding management of conflicts of interest and disclosures and the ACR guideline development process, which includes the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. It also adheres to the Appraisal of Guidelines for Research and Evaluation (AGREE) criteria. A core leadership team consisting of adult and pediatric rheumatologists and a guideline methodologist drafted clinical population, intervention, comparator, outcomes (PICO) questions. A review team performed a systematic literature review for the PICO questions, graded the quality of evidence, and produced an evidence report. An expert Voting Panel reviewed the evidence and formulated recommendations. The panel included adult and pediatric rheumatology providers, infectious diseases specialists, and patient representatives. Consensus required ≥70% agreement on both the direction and strength of each recommendation. RESULTS: This guideline includes expanded indications for some vaccines in patients with RMDs, as well as guidance on whether to hold immunosuppressive medications or delay vaccination to maximize vaccine immunogenicity and efficacy. Safe approaches to the use of live attenuated vaccines in patients taking immunosuppressive medications are also addressed. Most recommendations are conditional and had low quality of supporting evidence. CONCLUSION: Application of these recommendations should consider patients' individual risk for vaccine-preventable illness and for disease flares, particularly if immunosuppressive medications are held for vaccination. Shared decision-making with patients is encouraged in clinical settings.

2022 American College of Rheumatology Guideline for Vaccinations in Patients With Rheumatic and Musculoskeletal Diseases.

OBJECTIVE: To provide evidence-based recommendations on the use of vaccinations in children and adults with rheumatic and musculoskeletal diseases (RMDs). METHODS: This guideline follows American College of Rheumatology (ACR) policy guiding management of conflicts of interest and disclosures and the ACR guideline development process, which includes the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. It also adheres to the Appraisal of Guidelines for Research and Evaluation (AGREE) criteria. A core leadership team consisting of adult and pediatric rheumatologists and a guideline methodologist drafted clinical population, intervention, comparator, outcomes (PICO) questions. A review team performed a systematic literature review for the PICO questions, graded the quality of evidence, and produced an evidence report. An expert Voting Panel reviewed the evidence and formulated recommendations. The panel included adult and pediatric rheumatology providers, infectious diseases specialists, and patient representatives. Consensus required ≥70% agreement on both the direction and strength of each recommendation. RESULTS: This guideline includes expanded indications for some vaccines in patients with RMDs, as well as guidance on whether to hold immunosuppressive medications or delay vaccination to maximize vaccine immunogenicity and efficacy. Safe approaches to the use of live attenuated vaccines in patients taking immunosuppressive medications are also addressed. Most recommendations are conditional and had low quality of supporting evidence. CONCLUSION: Application of these recommendations should consider patients' individual risk for vaccine-preventable illness and for disease flares, particularly if immunosuppressive medications are held for vaccination. Shared decision-making with patients is encouraged in clinical settings.

Consumer Devices for Patient-Generated Health Data Using Blood Pressure Monitors for Managing Hypertension: Systematic Review.

BACKGROUND: In the era of digital health information technology, there has been a proliferation of devices that collect patient-generated health data (PGHD), including consumer blood pressure (BP) monitors. Despite their widespread use, it remains unclear whether such devices can improve health outcomes. OBJECTIVE: We performed a systematic review of the literature on consumer BP monitors that collect PGHD for managing hypertension to summarize their clinical impact on health and surrogate outcomes. We focused particularly on studies designed to measure the specific effect of using a BP monitor independent of cointerventions. We have also summarized the process and consumer experience outcomes. METHODS: An information specialist searched PubMed, MEDLINE, and Embase for controlled studies on consumer BP monitors published up to May 12, 2020. We assessed the risk of bias using an adapted 9-item appraisal tool and performed a narrative synthesis of the results. RESULTS: We identified 41 different types of BP monitors used in 49 studies included for review. Device engineers judged that 38 (92%) of those devices were similar to the currently available consumer BP monitors. The median sample size was 222 (IQR 101-416) participants, and the median length of follow-up was 6 (IQR 3-12) months. Of the included studies, 18 (36%) were designed to isolate the clinical effects of BP monitors; 6 of the 18 (33%) studies evaluated health outcomes (eg, mortality, hospitalizations, and quality of life), and data on those outcomes were unclear. The lack of clarity was due to low event rates, short follow-up duration, and risk of bias. All 18 studies that isolated the effect of BP monitors measured both systolic and diastolic BP and generally demonstrated a decrease of 2 to 4 mm Hg in systolic BP and 1 to 3 mm Hg in diastolic BP compared with non-BP monitor groups. Adherence to using consumer BP monitors ranged from 38% to 89%, and ease of use and satisfaction ratings were generally high. Adverse events were infrequent, but there were a few technical problems with devices (eg, incorrect device alerts). CONCLUSIONS: Overall, BP monitors offer small benefits in terms of BP reduction; however, the health impact of these devices continues to remain unclear. Future studies are needed to examine the effectiveness of BP monitors that transmit data to health care providers. Additional data from implementation studies may help determine which components are critical for sustained BP improvement, which in turn may improve prescription decisions by clinicians and coverage decisions by policy makers.

Effect of Intensive Blood Pressure Lowering on Cardiovascular Outcomes: A Systematic Review Prepared for the 2020 U.S. Department of Veterans Affairs/U.S. Department of Defense Guidelines.

BACKGROUND: Recent clinical trials suggest that treating patients with hypertension to lower blood pressure (BP) targets improves cardiovascular outcomes. PURPOSE: To summarize the effects of intensive (or targeted) systolic BP (SBP) and diastolic BP (DBP) lowering with pharmacologic treatment on cardiovascular outcomes and harms in adults with hypertension. DATA SOURCES: Multiple databases, including MEDLINE and EMBASE, were searched for relevant systematic reviews (SRs) published in English from 15 December 2013 through 25 March 2019, with updated targeted searches through 8 January 2020. STUDY SELECTION: 8 SRs of randomized controlled trials examining either a standardized SBP target of -10 mm Hg (1 SR) or BP lowering below a target threshold (7 SRs). DATA EXTRACTION: One investigator abstracted data, assessed study quality, and performed GRADE assessments; a second investigator checked abstractions and assessments. DATA SYNTHESIS: The main outcome of interest was reduction in composite cardiovascular outcomes. High-strength evidence showed benefit of a 10-mm Hg reduction in SBP for cardiovascular outcomes among patients with hypertension in the general population, patients with chronic kidney disease, and patients with heart failure. Evidence on reducing SBP for cardiovascular outcomes in patients with a history of cardiovascular disease (moderate strength) or diabetes mellitus (high strength) to a lower SBP target was mixed. Low-strength evidence supported intensive lowering to a 10-mm Hg reduction in SBP for cardiovascular outcomes in patients with a history of stroke. All reported harms were considered, including general adverse events, serious adverse events, cognitive impairment, fractures, falls, syncope, hypotension, withdrawals due to adverse events, and acute kidney injury. Safety results were mixed or inconclusive. LIMITATIONS: This was a qualitative synthesis of new evidence with existing meta-analyses. Data were sparse for outcomes related to treating DBP to a lower target or for patients older than 60 years. CONCLUSION: Overall, current clinical literature supports intensive BP lowering in patients with hypertension for improving cardiovascular outcomes. In most subpopulations, intensive lowering was favored over less-intensive lowering, but the data were less clear for patients with diabetes mellitus or cardiovascular disease. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs, Veterans Health Administration.

2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee

To develop an evidence- based guideline for the comprehensive management of osteoarthritis (OA) as a collabora-tion between the American College of Rheumatology (ACR) and the Arthritis Foundation, updating the 2012 ACR recommenda-tions for the management of hand, hip, and knee OA.Methods. We identied clinically relevant population, intervention, comparator, outcomes questions and critical outcomes in OA. A Literature Review Team performed a systematic literature review to summarize evidence supporting the benets and harms of available educational, behavioral, psychosocial, physical, mind- body, and pharmacologic therapies for OA. Grading of Recommen-dations Assessment, Development and Evaluation methodology was used to rate the quality of the evidence. A Voting Panel, includ-ing rheumatologists, an internist, physical and occupational therapists, and patients, achieved consensus on the recommendations.Results. Based on the available evidence, either strong or conditional recommendations were made for or against the ap-proaches evaluated. Strong recommendations were made for exercise, weight loss in patients with knee and/or hip OA who are overweight or obese, self- efcacy and self- management programs, tai chi, cane use, hand orthoses for rst carpometacarpal (CMC) joint OA, tibiofemoral bracing for tibiofemoral knee OA, topical nonsteroidal antiinammatory drugs (NSAIDs) for knee OA, oral NSAIDs, and intraarticular glucocorticoid injections for knee OA. Conditional recommendations were made for balance exer-cises, yoga, cognitive behavioral therapy, kinesiotaping for rst CMC OA, orthoses for hand joints other than the rst CMC joint, patellofemoral bracing for patellofemoral knee OA, acupuncture, thermal modalities, radiofrequency ablation for knee OA, topical NSAIDs, intraarticular steroid injections and chondroitin sulfate for hand OA, topical capsaicin for knee OA, acetaminophen, du-loxetine, and tramadol.Conclusion. This guideline provides direction for clinicians and patients making treatment decisions for the management of OA. Clinicians and patients should engage in shared decision- making that accounts for patients' values, preferences, and comor-bidities. These recommendations should not be used to limit or deny access to therapies

2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee.

OBJECTIVE: To develop an evidence-based guideline for the comprehensive management of osteoarthritis (OA) as a collaboration between the American College of Rheumatology (ACR) and the Arthritis Foundation, updating the 2012 ACR recommendations for the management of hand, hip, and knee OA. METHODS: We identified clinically relevant population, intervention, comparator, outcomes questions and critical outcomes in OA. A Literature Review Team performed a systematic literature review to summarize evidence supporting the benefits and harms of available educational, behavioral, psychosocial, physical, mind-body, and pharmacologic therapies for OA. Grading of Recommendations Assessment, Development and Evaluation methodology was used to rate the quality of the evidence. A Voting Panel, including rheumatologists, an internist, physical and occupational therapists, and patients, achieved consensus on the recommendations. RESULTS: Based on the available evidence, either strong or conditional recommendations were made for or against the approaches evaluated. Strong recommendations were made for exercise, weight loss in patients with knee and/or hip OA who are overweight or obese, self-efficacy and self-management programs, tai chi, cane use, hand orthoses for first carpometacarpal (CMC) joint OA, tibiofemoral bracing for tibiofemoral knee OA, topical nonsteroidal antiinflammatory drugs (NSAIDs) for knee OA, oral NSAIDs, and intraarticular glucocorticoid injections for knee OA. Conditional recommendations were made for balance exercises, yoga, cognitive behavioral therapy, kinesiotaping for first CMC OA, orthoses for hand joints other than the first CMC joint, patellofemoral bracing for patellofemoral knee OA, acupuncture, thermal modalities, radiofrequency ablation for knee OA, topical NSAIDs, intraarticular steroid injections and chondroitin sulfate for hand OA, topical capsaicin for knee OA, acetaminophen, duloxetine, and tramadol. CONCLUSION: This guideline provides direction for clinicians and patients making treatment decisions for the management of OA. Clinicians and patients should engage in shared decision-making that accounts for patients' values, preferences, and comorbidities. These recommendations should not be used to limit or deny access to therapies.

2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee.

OBJECTIVE: To develop an evidence-based guideline for the comprehensive management of osteoarthritis (OA) as a collaboration between the American College of Rheumatology (ACR) and the Arthritis Foundation, updating the 2012 ACR recommendations for the management of hand, hip, and knee OA. METHODS: We identified clinically relevant population, intervention, comparator, outcomes questions and critical outcomes in OA. A Literature Review Team performed a systematic literature review to summarize evidence supporting the benefits and harms of available educational, behavioral, psychosocial, physical, mind-body, and pharmacologic therapies for OA. Grading of Recommendations Assessment, Development and Evaluation methodology was used to rate the quality of the evidence. A Voting Panel, including rheumatologists, an internist, physical and occupational therapists, and patients, achieved consensus on the recommendations. RESULTS: Based on the available evidence, either strong or conditional recommendations were made for or against the approaches evaluated. Strong recommendations were made for exercise, weight loss in patients with knee and/or hip OA who are overweight or obese, self-efficacy and self-management programs, tai chi, cane use, hand orthoses for first carpometacarpal (CMC) joint OA, tibiofemoral bracing for tibiofemoral knee OA, topical nonsteroidal antiinflammatory drugs (NSAIDs) for knee OA, oral NSAIDs, and intraarticular glucocorticoid injections for knee OA. Conditional recommendations were made for balance exercises, yoga, cognitive behavioral therapy, kinesiotaping for first CMC OA, orthoses for hand joints other than the first CMC joint, patellofemoral bracing for patellofemoral knee OA, acupuncture, thermal modalities, radiofrequency ablation for knee OA, topical NSAIDs, intraarticular steroid injections and chondroitin sulfate for hand OA, topical capsaicin for knee OA, acetaminophen, duloxetine, and tramadol. CONCLUSION: This guideline provides direction for clinicians and patients making treatment decisions for the management of OA. Clinicians and patients should engage in shared decision-making that accounts for patients' values, preferences, and comorbidities. These recommendations should not be used to limit or deny access to therapies.

Clinically Localized Prostate Cancer: AUA/ASTRO/SUO Guideline. Part II: Recommended Approaches and Details of Specific Care Options.

PURPOSE: This guideline is structured to provide a clinical framework stratified by cancer severity to facilitate care decisions and guide the specifics of implementing the selected management options. The summary presented herein represents Part II of the two-part series dedicated to Clinically Localized Prostate Cancer: AUA/ASTRO/SUO Guideline discussing risk stratification and care options by cancer severity. Please refer to Part I for discussion of specific care options and outcome expectations and management. MATERIALS AND METHODS: The systematic review utilized in the creation of this guideline was completed by the Agency for Healthcare Research and Quality and through additional supplementation by ECRI Institute. This review included articles published between January 2007 and March 2014 with an update search conducted through August 2016. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. Additional information is provided as Clinical Principles and Expert Opinions (table 2 in supplementary unabridged guideline, http://jurology.com/). RESULTS: The AUA (American Urological Association), ASTRO, and SUO (Society of Urologic Oncology) formulated an evidence-based guideline based on a risk stratified clinical framework for the management of localized prostate cancer. CONCLUSIONS: This guideline attempts to improve a clinician's ability to treat patients diagnosed with localized prostate cancer, but higher quality evidence in future trials will be essential to improve the level of care for these patients. In all cases, patient preferences should be considered when choosing a management strategy.

Clinically Localized Prostate Cancer: AUA/ASTRO/SUO Guideline. Part I: Risk Stratification, Shared Decision Making, and Care Options.

PURPOSE: This guideline is structured to provide a clinical framework stratified by cancer severity to facilitate care decisions and guide the specifics of implementing the selected management options. The summary presented represents Part I of the two-part series dedicated to Clinically Localized Prostate Cancer: AUA/ASTRO/SUO Guideline discussing risk stratification and care options by cancer severity. MATERIALS AND METHODS: The systematic review utilized in the creation of this guideline was completed by the Agency for Healthcare Research and Quality and through additional supplementation by ECRI Institute. This review included articles published between January 2007 and March 2014 with an update search conducted through August 2016. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. Additional information is provided as Clinical Principles and Expert Opinions (table 2 in supplementary unabridged guideline, http://jurology.com/). RESULTS: The AUA (American Urological Association), ASTRO, and SUO (Society of Urologic Oncology) formulated an evidence-based guideline based on a risk stratified clinical framework for the management of localized prostate cancer. CONCLUSIONS: This guideline attempts to improve a clinician's ability to treat patients diagnosed with localized prostate cancer, but higher quality evidence in future trials will be essential to improve the level of care for these patients. In all cases, patient preferences should be considered when choosing a management strategy.

Systematic review: comparative effectiveness of core-needle and open surgical biopsy to diagnose breast lesions.

BACKGROUND: Most women undergoing breast biopsy are found not to have cancer. PURPOSE: To compare the accuracy and harms of different breast biopsy methods in average-risk women suspected of having breast cancer. DATA SOURCES: Databases, including MEDLINE and EMBASE, searched from 1990 to September 2009. STUDY SELECTION: Studies that compared core-needle biopsy diagnoses with open surgical diagnoses or clinical follow-up. DATA EXTRACTION: Data were abstracted by 1 of 3 researchers and verified by the primary investigator. DATA SYNTHESIS: 33 studies of stereotactic automated gun biopsy; 22 studies of stereotactic-guided, vacuum-assisted biopsy; 16 studies of ultrasonography-guided, automated gun biopsy; 7 studies of ultrasonography-guided, vacuum-assisted biopsy; and 5 studies of freehand automated gun biopsy met the inclusion criteria. Low-strength evidence showed that core-needle biopsies conducted under stereotactic guidance with vacuum assistance distinguished between malignant and benign lesions with an accuracy similar to that of open surgical biopsy. Ultrasonography-guided biopsies were also very accurate. The risk for severe complications is lower with core-needle biopsy than with open surgical procedures (<1% vs. 2% to 10%). Moderate-strength evidence showed that women in whom breast cancer was initially diagnosed by core-needle biopsy were more likely than women with cancer initially diagnosed by open surgical biopsy to be treated with a single surgical procedure (random-effects odds ratio, 13.7 [95% CI, 5.5 to 34.6]). LIMITATION: The strength of evidence was rated low for accuracy outcomes because the studies did not report important details required to assess the risk for bias. CONCLUSION: Stereotactic- and ultrasonography-guided core-needle biopsy procedures seem to be almost as accurate as open surgical biopsy, with lower complication rates. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Knowledge about glaucoma and barriers to follow-up care in a community glaucoma screening program.

OBJECTIVE: To assess perceived barriers to glaucoma follow-up care, including the lack of glaucoma knowledge and the lack of health care access, among participants in a community glaucoma screening program. DESIGN: Community survey. PARTICIPANTS: Two hundred forty-three consecutive participants in a series of free glaucoma screenings between November 2002 and August 2003. METHODS: The survey consisted of 20 questions designed to elicit knowledge of glaucoma and perception of potential barriers to follow-up care. Our aim was to find correlations between patient demographics and knowledge of glaucoma as well as perceived potential barriers to follow-up care. The data were analyzed using SPSS, v. 10.1. RESULTS: The average age of the respondents was 70 years, and females predominated (66%). About half of the respondents knew of an eye doctor in their neighborhood, and 60% had had an eye examination in the past year. Two hundred twenty-two (91%) indicated they could get to an eye doctor if the screening examination indicated they needed a follow-up examination. Two hundred twenty (90.5%) had medical insurance. One hundred seventy-eight (73%) of the participants had heard of glaucoma; 71 (29%) identified an accurate definition of glaucoma. The level of education and the language spoken at home were correlated with both glaucoma awareness (p < 0.001; p < 0.001) and knowledge of an accurate definition of glaucoma (p < 0.001; p < 0.025). CONCLUSIONS: In this population, a lack of adequate education about glaucoma may be more significantly associated with poor follow-up rates than a lack of access to care in those identified as glaucoma suspects.

Central corneal thickness in pediatric glaucoma.

PURPOSE: To compare the central corneal thickness (CCT) of children with and without glaucoma and to estimate the effect CCT may have on the intraocular pressure (IOP) assessment of children. PATIENTS AND METHODS: CCT and IOP measurements were performed in an unmasked fashion in 34 consecutive children with glaucoma and 28 consecutive children without glaucoma. Patients with corneal edema or extensive corneal scarring were excluded. IOPs in the pediatric glaucoma group were corrected for CCT using a linear algorithm; adjustments of 3 mm Hg or more were considered clinically significant. RESULTS: Mean CCT for eyes with glaucoma was 610.2+/-121.9 microm; for the control eyes, mean CCT was 555.6+/-38.4 microm (P < .001). Mean CCT was 543.3+/-66.9 microm for eyes with primary congenital glaucoma, 591.9+/-23.1 pm for those with Sturge-Weber syndrome, 662.7+/-68.7 microm for those with aphakic glaucoma, 754.5 +/-92.6 microm for those with aniridia, and 820.6+/-133.7 microm for those with microcornea (P < .001). Applying a correction formula for IOP with CCT adjustment, the adjusted IOP was overestimated by > or =3 mm Hg in 14 (41.2%) eyes and underestimated by > or = 3 mm Hg in 5 (14.7%) eyes. CONCLUSIONS: The mean CCT was higher for the pediatric glaucoma group than for the control group. However, the CCTs varied significantly depending on the specific diagnoses. CCT was estimated to have a clinically significant effect on IOP measurements in more than half of the patients with pediatric glaucoma. Pachymetry results should be considered in the management of these patients.

Subconjunctival sodium hyaluronate 2.3% in trabeculectomy: a prospective randomized clinical trial.

PURPOSE: To investigate the efficacy of subconjunctival sodium hyaluronate 2.3% in increasing the success rate of glaucoma filtering surgery and promoting filtering blebs with characteristics presumed to predict better success. DESIGN: Randomized controlled clinical trial. PARTICIPANTS: Fifty-five patients scheduled for glaucoma surgery. INTERVENTION: Patients underwent routine trabeculectomy, with or without phacoemulsification and intraocular lens implantation. In the study group (n = 28), sodium hyaluronate 2.3% was injected between the scleral and conjunctival flaps at the conclusion of the surgery. In the control group (n = 27), balanced salt solution (BSS) was injected in the same fashion, in an unmasked design. MAIN OUTCOMES MEASURES: Surgical success was defined as (1) a complete success if the intraocular pressure (IOP) was 21 mmHg or less without any antiglaucoma medication, and (2) a qualified success if the IOP was 21 mmHg or less, with or without antiglaucoma medication. Patients requiring additional surgery, including needling, or with IOP more than 21 mmHg, even when receiving antiglaucoma medications, were considered to have failed treatment. Success rates in both groups were compared using Kaplan-Meier survival curves and the log-rank test. The morphologic characteristics of the filtering blebs were evaluated using the Indiana Bleb Appearance Grading Scale. Other outcome measures were IOP, visual acuity, need for antiglaucoma medication, and any complications. RESULTS: Fifty-two patients completed the study (27 in the study group and 25 in the control group), with a mean follow-up of 12.3 months. Complete success rates were 77.8% for the study group and 84.0% for the control group 12 months after surgery (P>0.5); qualified success rates were 88.9% for the study group and 92.0% for the control group (P>0.6). Mean IOP decreased from 26.0+/-10.0 mmHg to 11.6+/-4.1 mmHg in the study eyes (P<0.001) and from 24.9+/-9.7 mmHg to 13.0+/-4.1 mmHg in the control eyes (P<0.001). Intraocular pressure measurements in both groups were similar at all visits (P>0.05). The study eyes had more diffuse blebs than the control eyes (62.5% > or =4 clock-hours vs. 22.7%; P = 0.012). Postoperative complications were similar in the study eyes (14.8%) and the control eyes (20.0%; P>0.6). CONCLUSIONS: There was no difference in success rates in patients who received subconjunctival sodium hyaluronate 2.3% compared to BSS injections. Subconjunctival sodium hyaluronate 2.3% was associated with more diffuse blebs after filtering surgery.

Intracameral 2.3% sodium hyaluronate to treat postoperative hypotony in patients with glaucoma.

BACKGROUND AND OBJECTIVE: To evaluate the intracameral use of Healon5 (2.3% sodium hyaluronate) (Advanced Medical Optics, Santa Ana, CA) in patients with hypotony. PATIENTS AND METHODS: Fifteen consecutive patients with glaucoma who had hypotony for at least 7 days were prospectively recruited. Indications for the intracameral injection of Healon5 were an intraocular pressure (IOP) of less than 6 mm Hg with negative results on Seidel test. RESULTS: The mean IOP readings at baseline, 1 to 2 weeks post-injection, and 4 to 6 weeks post-injection were 3.8 +/- 1.58, 6.58 +/- 2.62, and 6.50 +/- 2.24 mm Hg, respectively. The increase in IOP at both follow-up points was significant (P < .01). The visual acuity improvement was small but significant at the 4 to 6 week point (P = .05). In the early-onset cases, IOP increased significantly from baseline at both follow-up points (P< .05), but visual acuity did not. No significant change from baseline IOP or visual acuity occurred among the late-onset cases. The existing hypotony-related conditions consistently improved by the 4 to 6 week point. CONCLUSIONS: Intracameral injection of Healon5 raised IOP more in early-onset hypotony cases than in late-onset cases. Although the improvements in IOP and visual acuity were statistically significant, the overall clinical picture did not change because the endpoint IOP was still hypotonus. Twenty percent of the patients had IOP spikes that required medical treatment.

Clinical predictors of latanoprost treatment effect.

PURPOSE: To determine the relationship between latanoprost efficacy and clinical features of glaucoma. PATIENTS AND METHODS: Study design was retrospective, observational case series. The charts of all patients who underwent a one-eyed therapeutic trial of latanoprost during the course of their clinical care between 1997 and 2001 were reviewed. Intraocular pressures of both eyes prior to and one month after initiation of latanoprost were recorded. Latanoprost treatment effect was calculated by subtracting the change in intraocular pressure (IOP) in the fellow eye from the change in the treated eye. The effect of optic disc stage, age, race, sex, diagnosis, involved eye, type and number of other glaucoma medications, pattern of cupping (concentric, focal, or indeterminate), and pre-treatment IOP was correlated with the treatment effect. The stage of glaucoma was determined by determining the disc damage likelihood scale (DDLS) stage. RESULTS: One hundred eighty-six cases were included. Latanoprost treatment effect was 4.5 +/- 5.7 mm Hg, was moderately correlated with pre-treatment IOP (Pearson's r = 0.527, P < 0.01), and was weakly inversely correlated with advancing disc stage (Pearson's r = -0.194, P < 0.01) and age (Pearson's r = -0.175, P < 0.05). It was independent of the other variables studied (P > 0.05). CONCLUSION: Most clinical parameters examined in this study were not correlated with latanoprost treatment response. A moderate direct correlation was noted with pre-treatment IOP and a weak inverse correlation was noted with optic disc stage and age.

Timolol/dorzolamide combination therapy as initial treatment for intraocular pressure over 30 mm Hg.

PURPOSE: To determine the intraocular pressure (IOP)-lowering effect of a fixed timolol/dorzolamide combination (Cosopt) for patients with IOP over 30 mm Hg. STUDY DESIGN: Prospective interventional case series. METHODS: Eighteen patients being seen on the Wills Eye Hospital Glaucoma Service with at least one eye with an IOP > 30 mm Hg were recruited. None had used any glaucoma medications for at least 1 month. IOP was confirmed by diurnal testing. Cosopt was administered at 9 am and 9 pm. Trough IOP measurements were made at 9 am and peak IOP measurements at 11 am at baseline, 1 month, and 2 months. Pretreatment and posttreatment IOPs were compared using a paired-samples independent t test. RESULTS: Mean pretreatment IOP was 37.5 +/- 1.0 mm Hg. Baseline posttreatment IOP was 18.4 +/- 0.5 mm Hg (P < 0.01). At 2 months, the mean trough IOP was 21.1 +/- 0.9 mm Hg and the peak, 17.6 +/- 0.6 mm Hg (each, P < 0.01, as compared with pretreatment baseline IOP). One patient did not respond to Cosopt; two had a clinically insufficient response and did not complete the study. Data from these patients were included in the analysis. CONCLUSIONS: Over 80% of the eyes responded to Cosopt, with an average trough IOP reduction of 40% at 2 months.

Level of disagreement between Proview phosphene tonometer and Goldmann applanation tonometer intraocular pressure readings.

PURPOSE: To evaluate the agreement of intraocular pressure (IOP) readings obtained with the Proview phosphene tonometer and those obtained by Goldmann applanation tonometry as well as the effect of regular use of the Proview on patients' anxiety about their glaucoma. METHODS: One hundred thirty-five consecutive patients with glaucoma, 35 designated as controls, were enrolled in a 10-month randomized prospective clinical trial. The study patients but not the controls used the Proview outside the office. At office visits IOP was measured by an ophthalmologist with the Goldmann applanation tonometer (GAT) as well as by examiners and patients using the Proview. Patients in the treatment group (n = 100) were asked to measure and record their IOP at home as well. Using ANOVA, we examined the relationship between demographic variables and the level of agreement between the Proview readings and those measured by GAT at the final office visit. All participants also were asked to complete a questionnaire regarding their anxiety about their IOP at the baseline and final office visits. The primary outcome measure was the level of agreement of the Proview measurements with those obtained by GAT. Secondary outcome measures included patients' anxiety about their glaucoma. RESULTS: The absolute mean difference between GAT and Proview readings at the final visit was 3.5 +/- 2.9 mm Hg (median, 2.8 mm Hg). The treatment group reported significantly less anxiety about their glaucoma after 4 to 6 weeks of using the Proview (P = .024). CONCLUSIONS: There was considerable discrepancy between Proview and GAT readings. However, regular use of the Proview tonometer significantly reduced patients' anxiety about their glaucoma.

Risk factors for amblyopia in congenital anterior lens opacities.

PURPOSE: We sought to identify the features of congenital anterior lens opacities (CALOs), which are associated with increased risk for amblyopia. METHODS: We undertook a retrospective study of 59 patients with CALO from 3 clinical practices. The following variables were examined: type (polar, subcapsular, or pyramidal), location (central, paracentral, or peripheral), diameter, presence of adherent iris tissue, anisometropia (spherical equivalent), unilateral versus bilateral, and presence or absence of amblyopia. Pearson chi-square and independent sample t-tests were conducted to evaluate if any of the aforementioned variables were independently associated with amblyopia. Relative risk was then calculated for significantly related variables (P < 0.05). RESULTS: Amblyopia was present in 17 of 59 patients (28.8%). Patients with amblyopia had a mean anisometropia of 1.23 diopters whereas nonambyopic patients had a mean anisometropia of 0.25 (P = 0.023). The relative risk for amblyopia with anisometropia of one diopter or greater was 6.5 (95% confidence interval = 3.79-7.45). The mean cataract size in the amblyopic eyes was 1.22 mm (range, 0.7-2.0 mm). Mean cataract size in the nonamblyopic eyes was 0.95 mm (range, 0.5-2.0 mm). This difference in mean cataract size was significant with independent sample t-tests (P = 0.02); however, this difference did not remain significant with logistic regression. Cataract size was not a significant relative risk factor for amblyopia. CONCLUSIONS: Our overall incidence of amblyopia was 28.8%. The only variable associated with increased relative risk for amblyopia in this group of patients was anisometropia. Patients with CALO who have anisometropia of 1 diopter or greater are 6.5 times more likely to develop amblyopia.

Intermediate-term results of Baerveldt tube shunt surgery with mitomycin C use.

BACKGROUND AND OBJECTIVE: To study the intermediate-term results of the Baerveldt glaucoma drainage device with adjunctive use of intraoperative mitomycin C. PATIENTS AND METHODS: Charts of 243 consecutive patients with advanced glaucoma who had undergone tube shunt surgery between 1992 and 1999 were retrospectively analyzed. A total of 64 patients were eligible for the study. Patients were observed for a mean of 34.3 +/- 21 months. Kaplan-Meier survival analysis was used to determine intermediate-term success. RESULTS: The mean preoperative intraocular pressure (IOP) was 34.4 mm Hg and the 1-year postoperative IOP was 16.6 mm Hg. The mean percent IOP reduction after surgery was 51.7%, 53.2%, and 51.4% at 1, 2, and 5 years, respectively. Kaplan-Meier analysis showed a 77% success rate at 1 year, 66% at 2 years, and 59% at 5 years. The most common complication was choroidal detachment (18.8%). CONCLUSION: The use of mitomycin C with Baerveldt implantation showed IOP control equivalent to that without mitomycin C at intermediate follow-up.