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1.
Ophthalmology ; 129(10): 1177-1191, 2022 10.
Article in English | MEDLINE | ID: mdl-35714735

ABSTRACT

PURPOSE: To assess the safety of the subretinal delivery of a recombinant adeno-associated virus serotype 2 (AAV2) vector carrying a human choroideremia (CHM)-encoding cDNA in CHM. DESIGN: Prospective, open-label, nonrandomized, dose-escalation, phase I/II clinical trial. PARTICIPANTS: Fifteen CHM patients (ages 20-57 years at dosing). METHODS: Patients received uniocular subfoveal injections of low-dose (up to 5 × 1010 vector genome [vg] per eye, n = 5) or high-dose (up to 1 × 1011 vg per eye, n = 10) of a recombinant adeno-associated virus serotype 2 (AAV2) vector carrying a human CHM-encoding cDNA (AAV2-hCHM). Patients were evaluated preoperatively and postoperatively for 2 years with ophthalmic examinations, multimodal retinal imaging, and psychophysical testing. MAIN OUTCOME MEASURES: Visual acuity, perimetry (10-2 protocol), spectral-domain OCT (SD-OCT), and short-wavelength fundus autofluorescence (SW-FAF). RESULTS: We detected no vector-related or systemic toxicities. Visual acuity returned to within 15 letters of baseline in all but 2 patients (1 developed acute foveal thinning, and 1 developed a macular hole); the rest showed no gross changes in foveal structure at 2 years. There were no significant differences between intervention and control eyes in mean light-adapted sensitivity by perimetry or in the lateral extent of retinal pigment epithelium relative preservation by SD-OCT and SW-FAF. Microperimetry showed nonsignificant (< 3 standard deviations of the intervisit variability) gains in sensitivity in some locations and participants in the intervention eye. There were no obvious dose-dependent relationships. CONCLUSIONS: Visual acuity was within 15 letters of baseline after the subfoveal AAV2-hCHM injections in 13 of 15 patients. Acute foveal thinning with unchanged perifoveal function in 1 patient and macular hole in 1 patient suggest foveal vulnerability to the subretinal injections. Longer observation intervals will help establish the significance of the minor differences in sensitivities and rate of disease progression observed between intervention and control eyes.


Subject(s)
Choroideremia , Retinal Perforations , Adult , Choroideremia/diagnosis , Choroideremia/genetics , Choroideremia/therapy , DNA, Complementary , Dependovirus/genetics , Fluorescein Angiography , Genetic Therapy/methods , Humans , Middle Aged , Prospective Studies , Retinal Perforations/therapy , Serogroup , Tomography, Optical Coherence , Young Adult
2.
Retina ; 41(2): 266-276, 2021 Feb 01.
Article in English | MEDLINE | ID: mdl-32496343

ABSTRACT

PURPOSE: Randomized clinical trials have demonstrated the safety and efficacy of ocriplasmin in patients with vitreomacular traction (VMT), including those with macular hole (MH). The INJECT study prospectively evaluated ocriplasmin in the setting of clinical practice. METHODS: INJECT was a Phase 4, multicenter, prospective observational study. Patients were followed up for 12 months. Assessments included nonsurgical VMT resolution, nonsurgical MH closure, best-corrected visual acuity, occurrence of vitrectomy, and adverse events. RESULTS: The efficacy population (N = 395) received an ocriplasmin injection and had optical coherence tomography-confirmed VMT at baseline. At Day 28, the rate of nonsurgical VMT resolution was 40.7% in the overall group, and the rate of nonsurgical MH closure was 36.0% in the VMT with MH group. At Month 12, the rate of ≥2-line best-corrected visual acuity gain (irrespective of vitrectomy) was 36.8% in the overall group and 59.6% in the VMT with MH group. The percentage of patients who underwent vitrectomy in the study eye was 29.1% in the overall group and 55.6% in the VMT with MH group. Photopsia (9.8%) and vitreous floaters (6.8%) were the most frequent adverse events. CONCLUSION: The INJECT study showed that ocriplasmin is effective in a clinical setting in patients with VMT, with or without MH. No new safety signals were identified from this large and surgeon-selected patient group, although the significant limitations of the study design without an image reading center and scheduled study visit timings should be noted.


Subject(s)
Fibrinolysin/administration & dosage , Peptide Fragments/administration & dosage , Retinal Perforations/therapy , Tomography, Optical Coherence/methods , Vitreous Body/pathology , Vitreous Detachment/therapy , Aged , Aged, 80 and over , Female , Follow-Up Studies , Humans , Intravitreal Injections , Male , Middle Aged , Prospective Studies , Retinal Perforations/diagnosis , Treatment Outcome , Vitrectomy/methods , Vitreous Detachment/diagnosis
3.
Retina ; 41(4): 735-743, 2021 Apr 01.
Article in English | MEDLINE | ID: mdl-32697444

ABSTRACT

BACKGROUND/PURPOSE: To determinate the efficacy of the human amniotic membrane plugs with sulfur hexafluoride versus human amniotic membrane plug with air as endotamponade to treat macular holes that failed to close after vitrectomy plus internal limiting membrane peeling. Multimodal imaging was focused to evaluate preoperative features and postoperative changes. METHODS: Prospective interventional comparative study. Twenty eyes of 20 patients affected with macular hole that failed to close were divided into 2 groups: 10 eyes received an amniotic membrane plug with 20% sulfur hexafluoride tamponade and 10 eyes received an amniotic membrane plug with air tamponade. All eyes were studied using multimodal advanced diagnostic tools, such as spectral-domain optical coherence tomography, optical coherence tomography angiography, microperimetry, and adaptive optics to investigate the postoperative results. RESULTS: In both groups, all macular holes were found successfully closed after 12 months. Mean preoperative best-corrected visual acuity was 20/400 in the SF6 group and 20/250 in air group. Final mean best-corrected visual acuity was 20/63 in both groups. The superficial capillary plexus, studied using optical coherence tomography angiography, showed a statistically significant difference between the treated and the fellow eyes. Adaptive optics images revealed the presence of a photoreceptor cell mosaic in the area of the amniotic membrane plug. CONCLUSION: The human amniotic membrane combined with air endotamponade demonstrated its effectiveness to seal macular holes that failed to close after vitrectomy plus internal limiting membrane peeling. Advanced multimodal diagnostic imaging helped us to better understand the modifications associated with the use of the amniotic membrane in these cases.


Subject(s)
Air , Amnion/transplantation , Endotamponade/methods , Retinal Perforations/therapy , Sulfur Hexafluoride/administration & dosage , Adult , Aged , Aged, 80 and over , Combined Modality Therapy , Female , Fluorescein Angiography , Humans , Male , Middle Aged , Prone Position , Prospective Studies , Retinal Perforations/physiopathology , Retinal Perforations/surgery , Tomography, Optical Coherence , Treatment Outcome , Visual Acuity/physiology , Vitrectomy
4.
Retina ; 41(4): 671-678, 2021 Apr 01.
Article in English | MEDLINE | ID: mdl-33346626

ABSTRACT

PURPOSE: This article aims to review current evidence on the development, diagnosis, and management of retinal pigment epithelium (RPE) tear during anti-vascular endothelial growth factor (VEGF) therapy. METHODS: Literature searches were performed using MEDLINE/PubMed databases (cut-off date: August 2019). RESULTS: Three key recommendations were made based on existing literature and clinical experience: 1) Multimodal imaging with color fundus photography, optical coherence tomography, near-infrared reflectance imaging, fundus autofluorescence imaging, optical coherence tomography-angiography, and/or fluorescein angiography are recommended to diagnose RPE tear and assess risk factors. Retinal pigment epithelium tears can be graded by size and foveal involvement. 2) Patients at high risk of developing RPE tear should be monitored after each anti-VEGF injection. If risk factors worsen, it is not yet definitively known whether anti-VEGF administration should be more frequent, or alternatively stopped in such patients. Prospective research into high-risk characteristics is needed. 3) After RPE tear develops, anti-VEGF treatment should be continued in patients with active disease (as indicated by presence of intraretinal or subretinal fluid), although cessation of therapy should be considered in eyes with multilobular tears. CONCLUSION: Although evidence to support the assumption that anti-VEGF treatment contributes to development of RPE tear is not definitive, some data suggest this link.


Subject(s)
Angiogenesis Inhibitors/therapeutic use , Retinal Perforations/diagnostic imaging , Retinal Perforations/therapy , Retinal Pigment Epithelium/diagnostic imaging , Vascular Endothelial Growth Factor A/antagonists & inhibitors , Choroidal Neovascularization/drug therapy , Humans , Intravitreal Injections , Multimodal Imaging , Risk Factors , Wet Macular Degeneration/drug therapy
5.
Retina ; 40(9): 1751-1756, 2020 Sep.
Article in English | MEDLINE | ID: mdl-31567816

ABSTRACT

PURPOSE: This study evaluates the efficacy and usefulness of vitrectomy with internal limiting membrane peeling and autologous blood clot covering without gas tamponade in the treatment of macular holes (MHs). METHODS: All patients with a full-thickness MH with a minimum diameter of <600 µm and a base diameter of <1,200 µm underwent pars plana vitrectomy and internal limiting membrane peeling with autologous blood covering the MH at the end of the surgery. No fluid-air exchange or gas tamponade was performed. Postoperatively, all patients were instructed to adopt supine position overnight and thereafter any comfortable posture. RESULTS: A total of 18 eyes of 18 consecutive patients were included. The mean age of the patients (12 women and 6 men) was 59.06 ± 14.31 years (range, 21-81 years). The MHs composed of 13 idiopathic MHs, 2 MHs with high myopia (axial length > 26.5 mm), 2 traumatic MHs, and 1 MH associated with diabetic macular edema. Among them were five large MHs (minimum diameter > 400 µm). Complete MH closure was achieved in all eyes at the end of the follow-up period (range, 3-14 months). Visual acuity was significantly improved from preoperative 0.89 ± 0.41 logarithm of the minimum angle of resolution (20/155 Snellen) to 0.42 ± 0.33 logarithm of the minimum angle of resolution (20/53 Snellen) at the final visit (P < 0.001). CONCLUSION: The novel surgical protocol using vitrectomy, internal limiting membrane peeling, and autologous blood clot covering at the end of the MH surgery with limited diameters achieved highly effective closure and visual improvement and eliminated the gas tamponade and thus the associated adverse effects and the need for postoperative face-down positioning.


Subject(s)
Basement Membrane/surgery , Retinal Perforations/therapy , Thrombosis , Vitrectomy , Adult , Aged , Aged, 80 and over , Endotamponade , Female , Humans , Male , Middle Aged , Retinal Perforations/diagnosis , Retinal Perforations/physiopathology , Retrospective Studies , Supine Position , Tomography, Optical Coherence , Visual Acuity/physiology , Young Adult
6.
BMC Ophthalmol ; 20(1): 171, 2020 Apr 29.
Article in English | MEDLINE | ID: mdl-32349686

ABSTRACT

BACKGROUND: Here we report two patients who developed an atypical macular hole (MH) during the treatment course for diabetic macular edema (DME). CASE PRESENTATIONS: Patient 1 was a 73-year-old male. Optical coherence tomography (OCT) revealed perifoveal retinoschisis (RS) in addition to cystoid macular edema and serous retinal detachment (SRD) in his left eye, and that an MH had developed during the clinical course. A convex surface was formed at the MH margin toward the vitreous cavity, and granular shadows were observed in the fluid cuff. Intraoperative findings revealed a thin epiretinal macular membrane (ERM) around the MH. Patient 2 was a 79-year-old male. Although the patient underwent pars plana vitrectomy (PPV) for proliferative diabetic retinopathy (PDR) in both eyes, RS and a thin ERM in addition to SRD was observed in his left eye after surgery, and an MH developed during the clinical course. As in Patient 1, a convex surface was formed at the fluid cuff margin toward the vitreous cavity. CONCLUSIONS: Both patients had persistent DME, SRD, RS, and a thin ERM before the development of the MH. OCT revealed the formation of a convex surface at the MH margin toward the vitreous cavity, suggesting that the fragility of the layered structure of the retina combined with tangential retinal traction may have been involved in the atypical MH form.


Subject(s)
Diabetic Retinopathy/complications , Macular Edema/complications , Retinal Perforations/etiology , Aged , Angiogenesis Inhibitors/therapeutic use , Diabetic Retinopathy/diagnosis , Diabetic Retinopathy/therapy , Epiretinal Membrane/complications , Epiretinal Membrane/diagnosis , Epiretinal Membrane/therapy , Humans , Intraocular Pressure , Intravitreal Injections , Macular Edema/diagnosis , Macular Edema/therapy , Male , Receptors, Vascular Endothelial Growth Factor/therapeutic use , Recombinant Fusion Proteins/therapeutic use , Retinal Detachment/complications , Retinal Detachment/diagnosis , Retinal Detachment/therapy , Retinal Perforations/diagnosis , Retinal Perforations/therapy , Retinoschisis/complications , Retinoschisis/diagnosis , Retinoschisis/therapy , Tomography, Optical Coherence , Vascular Endothelial Growth Factor A/antagonists & inhibitors , Visual Acuity , Vitrectomy
7.
Ophthalmologica ; 242(4): 214-221, 2019.
Article in English | MEDLINE | ID: mdl-31509827

ABSTRACT

PURPOSE: To identify the predictors for anatomical and functional outcome after re-vitrectomy with application of autologous platelet concentrate (APC) in eyes with persistent idiopathic macular hole (MH). METHODS: Retrospective study of 103 eyes with persistent MHs after vitrectomy with peeling of internal limiting membrane (ILM) and expansive gas. All patients underwent re-vitrectomy with APC and endotamponade. The anatomical MH closure rate and postoperative best-corrected visual acuity (BCVA) were evaluated. Further, predictive factors influencing the success of the surgery were analyzed. RESULTS: Median BCVA (logMAR) before the surgery was 1.00 (interquartile range [IQR] 0.80-1.30) and the median of minimum diameter between hole edges was 508 µm (IQR 387-631). The final closure rate after re-vitrectomy with APC was 60.2% (62 of 103 eyes). The following predictors were identified to significantly influence the closure rate: tractional hole index (THI), axial length, time between first and second surgery, and the experience of the surgeon (p < 0.05). CONCLUSIONS: Re-vitrectomy with APC led to the closure of 60.2% of the persistent MHs. The closure rate negatively correlates with increasing axial length, time between the first and second surgery, and the decreased THI. Further, experienced surgeons (with a history of >100 pars plana vitrectomies with ILM peeling) had significantly higher closure rates.


Subject(s)
Blood Platelets , Blood Transfusion, Autologous/methods , Endotamponade/methods , Macula Lutea/pathology , Retinal Perforations/therapy , Visual Acuity , Vitrectomy/methods , Aged , Female , Follow-Up Studies , Humans , Male , Prognosis , Reoperation , Retinal Perforations/diagnosis , Retrospective Studies , Tomography, Optical Coherence , Treatment Outcome
8.
Biometrics ; 74(4): 1383-1394, 2018 12.
Article in English | MEDLINE | ID: mdl-29870064

ABSTRACT

Standard profiling analysis aims to evaluate medical providers, such as hospitals, nursing homes, or dialysis facilities, with respect to a patient outcome. The outcome, for instance, may be mortality, medical complications, or 30-day (unplanned) hospital readmission. Profiling analysis involves regression modeling of a patient outcome, adjusting for patient health status at baseline, and comparing each provider's outcome rate (e.g., 30-day readmission rate) to a normative standard (e.g., national "average"). Profiling methods exist mostly for non time-varying patient outcomes. However, for patients on dialysis, a unique population which requires continuous medical care, methodologies to monitor patient outcomes continuously over time are particularly relevant. Thus, we introduce a novel time-dynamic profiling (TDP) approach to assess the time-varying 30-day readmission rate. TDP is used to estimate, for the first time, the risk-standardized time-dynamic 30-day hospital readmission rate, throughout the time period that patients are on dialysis. We develop the framework for TDP by introducing the standardized dynamic readmission ratio as a function of time and a multilevel varying coefficient model with facility-specific time-varying effects. We propose estimation and inference procedures tailored to the problem of TDP and to overcome the challenge of high-dimensional parameters when examining thousands of dialysis facilities.


Subject(s)
Biometry/methods , Patient Readmission/statistics & numerical data , Retinal Perforations/therapy , Humans , Outcome Assessment, Health Care , Risk Factors , Time Factors
9.
Graefes Arch Clin Exp Ophthalmol ; 256(11): 2041-2052, 2018 Nov.
Article in English | MEDLINE | ID: mdl-30167916

ABSTRACT

PURPOSE: To assess the efficacy of mesenchymal stem cells (MSCs) and MSC-derived exosomes (MSC-Exos) to promote the healing of large and refractory macular holes (MHs). METHODS: Seven patients (age 51-75 years old) with large and long-standing idiopathic MHs underwent vitrectomy, internal limiting membrane peeling, MSC (two patients) or MSC-Exo (five patients) intravitreal injection, and heavy silicon oil, air, 20% SF6, or 14% C3F8 tamponade. The MSCs were isolated from human umbilical cord tissue, and MSC-Exos were isolated from the supernatants of cultured MSCs using sequential ultracentrifugation. RESULTS: Five eyes underwent pars plana vitrectomy (PPV) only, while two underwent PPV combined with cataract surgery. Six MHs were closed, while one remained in a flat-open state. The best-corrected visual acuity (BCVA) was improved in five patients with MH closure and remained unchanged in one patient with MH closure who had a 4-year history of MH. A fibrotic membrane was observed on the surface of the retina in one patient who underwent MSC therapy. One patient who received a higher dose of MSC-Exos exhibited an inflammatory reaction. CONCLUSIONS: MSC and MSC-Exo therapy may promote functional and anatomic recovery from MH. MSC-Exo therapy may be a useful and safe method for improving the visual outcomes after surgery for refractory MHs.


Subject(s)
Exosomes/transplantation , Mesenchymal Stem Cell Transplantation , Retinal Perforations/therapy , Vitrectomy , Wound Healing/physiology , Aged , Cataract Extraction , Endotamponade , Female , Flow Cytometry , Fluorocarbons/administration & dosage , Follow-Up Studies , Humans , Intravitreal Injections , Male , Middle Aged , Pilot Projects , Retinal Perforations/diagnostic imaging , Retinal Perforations/physiopathology , Retrospective Studies , Silicone Oils/administration & dosage , Tomography, Optical Coherence , Visual Acuity/physiology
10.
Ophthalmologica ; 239(1): 19-26, 2018.
Article in English | MEDLINE | ID: mdl-29050013

ABSTRACT

PURPOSE: To evaluate long-term outcome after revitrectomy with autologous platelet concentrate (APC) or whole blood (WB) in persistent idiopathic macular hole (MH) after vitrectomy with internal limiting membrane (ILM) peeling. PROCEDURES: Retrospective study of 75 eyes with persistent MH after vitrectomy with ILM peeling and gas. All patients underwent revitrectomy with gas and APC (n = 61) or WB (n = 14). Main outcome measures were anatomical closure rate and postoperative best-corrected visual acuity (BCVA). RESULTS: Closure rate after revitrectomy was 85.2% (52/61) in the APC group and 7.1% (1/14) in the WB group. Median follow-up was 58 (range 3-147) months. Median BCVA (logMAR) in patients with finally closed MHs was 0.4 ± 0.3. Patients with defects of the ellipsoid zone had significantly worse postoperative BCVA. Morphological MH configuration (atrophic or elevated edges) did not correlate with final closure rate. CONCLUSIONS: Revitrectomy with APC and gas is a very effective treatment in persistent MH after vitrectomy with ILM peeling and gas.


Subject(s)
Blood Platelets , Blood Transfusion, Autologous/methods , Macula Lutea/pathology , Retinal Perforations/therapy , Tomography, Optical Coherence/methods , Visual Acuity , Vitrectomy/methods , Aged , Aged, 80 and over , Endotamponade/methods , Female , Follow-Up Studies , Humans , Male , Middle Aged , Reoperation , Retinal Perforations/diagnosis , Retinal Perforations/etiology , Retrospective Studies , Time Factors , Treatment Outcome
11.
Graefes Arch Clin Exp Ophthalmol ; 255(11): 2081-2089, 2017 Nov.
Article in English | MEDLINE | ID: mdl-28755165

ABSTRACT

PURPOSE: To assess treatment effects following intravitreal injection of ocriplasmin for vitreomacular traction (VMT), with or without full-thickness macular hole (FTMH), in real-life setting. METHODS: This is a monocentric, retrospective, consecutive series of 82 eyes from 82 patients who underwent ocriplasmin treatment between July 2013 and December 2016. We included 57 eyes with pure VMT, 17 eyes with small FTMHs, and eight eyes with medium FTMHs. Primary outcome measures were VMT release and MH closure rates. Secondary outcomes were visual acuity (VA), morphological changes, and subjective visual impairment after 1, 3, and 6 months and at last follow-up. RESULTS: After a median follow-up of 10 months, VMT release was achieved by pharmacologic vitreolysis in 57% of all eyes, whereas the macular hole closure rate was 32%. In those presenting with five or more positive prognostic factors (PPF), eyes with pure VMT showed nonsurgical traction release in 88%, and FTMHs were released in 93%, with a closure rate of 20%. Small FTMHs closed in 41% and medium FTMHs in 13%. The mean change in VA (LogMAR) was -0.07 ± 0.24 (median - 0.10) in all eyes. Subretinal fluid accumulation and ellipsoid zone changes were seen in 31% and 37% of all eyes, respectively. They were more frequent in eyes with traction release, but were self-limited. CONCLUSIONS: In a real-life setting, release of VMT by ocriplasmin injection can be achieved in the majority of eyes, relying on a strict patient selection. Closure of FTMHs rather correlates with hole diameter than with presence of PPF, and remains a rare finding in medium FTMHs.


Subject(s)
Fibrinolysin/administration & dosage , Peptide Fragments/administration & dosage , Retinal Perforations/therapy , Vitreous Detachment/drug therapy , Dose-Response Relationship, Drug , Female , Humans , Intravitreal Injections , Male , Retinal Perforations/diagnosis , Retinal Perforations/etiology , Retrospective Studies , Tomography, Optical Coherence , Treatment Outcome , Visual Acuity , Vitrectomy/methods , Vitreous Detachment/complications , Vitreous Detachment/surgery
12.
Graefes Arch Clin Exp Ophthalmol ; 254(11): 2095-2099, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27520464

ABSTRACT

BACKGROUND: To present the surgical technique and clinical outcomes of transplantation of autologous internal limiting membrane (ILM) for large macular holes (MHs) after failed surgeries with ILM removal. METHODS: Thirteen eyes of 13 consecutive patients with MHs larger than 500 µm after failed surgeries with ILM removal underwent vitrectomy with transplantation of autologous ILM. In the ILM transplantation technique, a small piece of the ILM was peeled off and transplanted inside the macular hole. Fluid-air exchange was then performed. The air was then replaced with 10 % perfluoropropane (C3F8) gas. Comprehensive ophthalmologic examinations and spectral-domain optical coherence tomography were performed preoperatively and postoperatively. The main outcome measures were best-corrected Snellen visual acuity (BCVA) and MH closure rate. RESULTS: The preoperative mean base diameter of the MHs was 1637.6 + 412.7 µm (range, 814-2092 µm). The preoperative mean minimum diameter was 814.4 + 255.0 µm (range, 546 µm-1485 µm). Complete MH sealing was achieved in 12 eyes after transplantation of the ILM flap. The mean BCVA was 1.15 + 0.21 (range, 1.0-1.6) before surgery and 0.99 + 0.17 (range, 0.7-1.3) at 12 months postoperatively. There was a significant difference in BCVA before versus after the surgery (t = 3.825, P = 0.0002, paired t- test). CONCLUSIONS: Transplantation of autologous ILM is an effective addition to the surgical options for large macular holes after failed surgeries with ILM removal.


Subject(s)
Basement Membrane/transplantation , Ophthalmologic Surgical Procedures/methods , Retinal Perforations/therapy , Visual Acuity , Adult , Aged , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies , Reoperation , Retinal Perforations/diagnosis , Retinal Perforations/surgery , Tomography, Optical Coherence , Treatment Outcome , Young Adult
13.
Retina ; 36(4): 688-94, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26418444

ABSTRACT

PURPOSE: To compare the efficacy of a mixture of silicone oil and perfluorohexyloctane (Densiron 68) with C2F6 gas endotamponade in the retreatment of persistently open full-thickness macular holes. METHODS: In this prospective randomized study, 21 consecutive patients who were unsuccessfully operated on for large idiopathic full-thickness macular hole were randomly assigned to undergo a second vitrectomy with 20% perfluoroethane gas (C2F6, Group A) or with Densiron 68 tamponade (Group B). PRIMARY OUTCOMES: Endpoint (12 months) full-thickness macular hole closure rate by spectral domain optical coherence tomography and logMAR corrected distance visual acuity. SECONDARY OUTCOMES: postoperative adverse events. RESULTS: The mean diameter of macular holes before the second pars plana vitrectomy was 680.3 ± 120.8 µm and 740.5 ± 105.3 µm in Groups A and B, respectively (P = 0.237); mean preoperative corrected distance visual acuity was 0.96 ± 0.36 logMAR and 1.12 ± 0.35 logMAR, respectively (P = 0.315). Endpoint full-thickness macular hole closure was obtained in 30% of patients (3/10) in Group A and in 82% (9/11) in Group B (P = 0.030). Corrected distance visual acuities were, respectively, 0.80 ± 0.25 logMAR and 0.55 ± 0.20 logMAR, with significant intergroup difference (P = 0.019); corrected distance visual acuity increased in Group B only (P = 0.003). No differences in complications were found. CONCLUSION: The results indicate that Densiron 68 tamponade could be a useful, safe, and more efficacious method than gas tamponade to retreat persisting macular holes.


Subject(s)
Endotamponade , Fluorocarbons/administration & dosage , Retinal Perforations/therapy , Silicone Oils/administration & dosage , Vitrectomy , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Prospective Studies , Reoperation , Retinal Perforations/diagnosis , Retinal Perforations/physiopathology , Tomography, Optical Coherence , Visual Acuity/physiology
14.
Klin Monbl Augenheilkd ; 233(12): 1362-1366, 2016 Dec.
Article in German | MEDLINE | ID: mdl-27984839

ABSTRACT

Background: The influence of the width of a full-thickness macular hole on preoperative visual acuity and its role for the intraoperative approach and closure rate were analysed in a prospective study. Methods: For 47 patients with a full thickness macular hole, a precise analysis of the central retina was performed with SD-OCT. An SF6-gas-air mixture was used, with a lower concentration (15 %) for smaller holes ≤ 400 µm (group 1, n = 17) and a higher concentration (30 %) for larger holes > 400 µm (group 2, n = 30). Besides preoperative visual acuity, postoperative IOP fluctuations and closure rate were reviewed. Results: The mean hole width with SD-OCT was 419 ± 155 µm, with a significant negative correlation with preoperative visual acuity (r = - 0.56, p = 0.002). In the first group, mean early postoperative IOP was 23 mmHg and in the second group 33 mmHg (p < 0.001). Thus, for small macular holes, early postoperative IOP decompensation from gas expansion in the eye could be minimised. The closure rate was 90 %, with no significant difference between the two groups (p > 0.05). Conclusion: Determining the width of a macular hole with SD-OCT is an important indicator for the necessary endotamponade. Using a lower gas concentration (15 %) for smaller holes (≤ 400 µm) to prevent postoperative IOP fluctuations does not negatively influence closure rates.


Subject(s)
Endotamponade/methods , Macula Lutea/pathology , Retinal Perforations/pathology , Retinal Perforations/therapy , Vision Disorders/prevention & control , Visual Acuity , Aged , Female , Humans , Male , Recovery of Function , Treatment Outcome , Vision Disorders/diagnosis , Vision Disorders/etiology , Wound Healing
15.
Klin Monbl Augenheilkd ; 233(5): 622-30, 2016 May.
Article in German | MEDLINE | ID: mdl-27187883

ABSTRACT

Treatment is usually indicated for symptomatic vitreomacular traction (VMT) with or without a full thickness macular hole (FTMH) and without spontaneous resolution. Ultrastructural parameters are evaluated by SD-OCT, in order to classify the vitreoretinal interface and to estimate the success rate of treatment. The resolution rate after therapy with intravitreal Jetrea® (Ocriplasmin) is high (up to 70 %) in patients with symptomatic focal vitreomacular traction (≤ 1500 µm) with or without a macular hole (≤ 250 µm) and with no epiretinal membrane (ERM), but depends on the exact baseline analysis. All other patients with idiopathic traction retinopathy should be treated by minimal invasive pars plana vitrectomy (MIVI). Vitreoretinal surgery effectively removes traction and gives a high closure rate of a full thickness macular hole (FTMH, 90 to 100 %). It is now a very safe procedure with few side effects. Despite a low risk profile (cataract, retinal tear etc.) the indication for surgery needs to take the safety profile into account. Therefore vitrectomy is only indicated in symptomatic patients complaining of blurred vision, VA reduction and metamorphopsia. Vitrectomy is also indicated in patients whose treatment by pharmacologic vitreolysis has failed.


Subject(s)
Retinal Detachment/therapy , Retinal Perforations/therapy , Tissue Adhesions/therapy , Vitreous Detachment/therapy , Combined Modality Therapy/methods , Evidence-Based Medicine , Fibrinolysin/administration & dosage , Fibrinolytic Agents/administration & dosage , Humans , Peptide Fragments/administration & dosage , Retinal Detachment/complications , Retinal Detachment/diagnosis , Retinal Detachment/pathology , Retinal Perforations/complications , Retinal Perforations/diagnosis , Retinal Perforations/pathology , Tissue Adhesions/complications , Tissue Adhesions/diagnosis , Tissue Adhesions/pathology , Tomography, Optical Coherence/methods , Treatment Outcome , Vitrectomy/methods , Vitreous Detachment/complications , Vitreous Detachment/pathology
16.
Klin Oczna ; 118(4): 308-11, 2016.
Article in Polish | MEDLINE | ID: mdl-29911365

ABSTRACT

The article presents a case of an 18-year old man with bilateral optic disc pit associated with serous macular detachment in the left eye. Optic disc pit is a rare congenital abnormality of the optic nerve head, which affects 1:11 000 people, with no gender predilection. Optic disc pits are usually incidental findings on fundus examination. In ophthalmic examination, optic disc pit presents as an oval, gray, white or yellowish depression in the optic disc, commonly involving temporal quadrants, but may be situated in any sector. Approximately 25­75% of eyes with optic disc pits have a poor visual prognosis, as a result of serous macular detachment and macular holes. There are no guidelines on the management of patients with optic disc pit maculopathy. Numerous techniques have been described, including laser photocoagulation, intravitreal gas injection and pars plana vitrectomy with many different modifications.


Subject(s)
Retinal Detachment/diagnosis , Retinal Perforations/diagnosis , Adolescent , Humans , Male , Optic Disk/abnormalities , Retinal Detachment/complications , Retinal Detachment/congenital , Retinal Detachment/therapy , Retinal Perforations/complications , Retinal Perforations/congenital , Retinal Perforations/therapy
18.
Ophthalmologica ; 233(3-4): 134-45, 2015.
Article in English | MEDLINE | ID: mdl-25832909

ABSTRACT

PURPOSE: To investigate whether patients with exudative age-related macular degeneration and a submacular hemorrhage, retinal pigment epithelium (RPE) tear or nonresponders to anti-vascular endothelial growth factor (VEGF) benefit more from a free RPE-choroid graft transplantation surgery than from (continuation of) anti-VEGF treatment. PROCEDURES: A total of 20 patients were included in this prospective, international, multicenter, randomized intervention study. RESULTS: The change in the mean number of Early Treatment of Diabetic Retinopathy Study (ETDRS) letters in the graft group 1 year postoperatively was -15 (range -54 to +26), whilst 2 patients experienced a gain of >10 letters. The median preoperative visual acuity (VA) was 0.75 logMAR (range 0.46-2.8), and the mean postoperative VA was 1.48 logMAR (range 0.14-2.8). The change in the mean number of ETDRS letters in the anti-VEGF group was -8 (range -26 to +6); no patients experienced a >10 letter gain. The median preoperative VA was 1.36 logMAR (range 0.58-1.6), and the median postoperative VA was 1.42 logMAR (range 0.44-1.66). CONCLUSIONS: The included patient group is far too small to draw conclusions. However, both gain and loss of VA may be experienced by patients undergoing either treatment method; more gain might be possible for patients with a graft in the absence of complications.


Subject(s)
Angiogenesis Inhibitors/therapeutic use , Choroid/transplantation , Retinal Pigment Epithelium/transplantation , Vascular Endothelial Growth Factor A/antagonists & inhibitors , Wet Macular Degeneration/therapy , Aged , Aged, 80 and over , Female , Humans , Intravitreal Injections , Male , Middle Aged , Prospective Studies , Retinal Hemorrhage/therapy , Retinal Perforations/therapy , Tomography, Optical Coherence , Visual Acuity/physiology , Wet Macular Degeneration/drug therapy , Wet Macular Degeneration/physiopathology , Wet Macular Degeneration/surgery
19.
J R Army Med Corps ; 161(4): 348-50, 2015 Dec.
Article in English | MEDLINE | ID: mdl-25525204

ABSTRACT

A high-powered laser is an essential part of a modern military rangefinder; however, this paper presents three cases with macular injury resulting from a high-powered tank laser telemetry device. All injuries occurred when another user deliberately pointed the telemetry target unit at the patient's eyes. The devastating effect of this high-powered laser resulted in a permanent foveal scar in the second patient and a macular hole formation in the third patient. This report emphasises that education plays a primary role in preventing accidental laser injuries. Using general guidelines and safety regulations will prevent accidental macular injuries.


Subject(s)
Lasers/adverse effects , Military Personnel , Occupational Injuries/diagnosis , Occupational Injuries/etiology , Retinal Perforations/diagnosis , Retinal Perforations/etiology , Humans , Male , Occupational Injuries/therapy , Retinal Perforations/therapy , Telemetry/adverse effects , Telemetry/instrumentation , Young Adult
20.
Ophthalmology ; 121(9): 1720-6, 2014 Sep.
Article in English | MEDLINE | ID: mdl-24835758

ABSTRACT

OBJECTIVE: To evaluate cost-effectiveness and cost utilities for treatment options for vitreomacular adhesions (VMAs) and full-thickness macular holes (MHs). DESIGN: A Markov model of cost-effectiveness and utility. PARTICIPANTS: There were no participants. METHODS: Outcomes of published clinical trials (index studies) of surgical treatment of VMAs and MHs and a prospective, multicenter clinical trial of pharmaceutical vitreolysis with intravitreal ocriplasmin with saline control were used to generate a model for costs of treatment and visual benefits. All techniques were assumed to result in a 2.5-line visual benefit if anatomy was resolved. Markov analysis, with cost data from the Centers for Medicare and Medicaid Services, was used to calculate imputed costs for each primary treatment modality in a facility setting, with surgery performed in a hospital serving as the highest end of the range and nonfacility setting with surgery performed in an ambulatory surgery center serving as the lowest end of the range. MAIN OUTCOME MEASURES: Imputed costs of therapy, cost per line saved, cost per line-year saved, cost per quality-adjusted life years (QALYs). RESULTS: When pars plana vitrectomy (PPV) was selected as the primary procedure, the overall imputed cost ranged from $5802 to $7931. The cost per line was $2368 to $3237, the cost per line-year saved was $163 to $233 and the cost per QALY was $5444 to $7442. If intravitreal injection of ocriplasmin was the primary procedure, the overall imputed cost was $8767 to $10 977. The cost per line ranged from $3549 to $4456, the cost per line-year saved was $245 to $307, and the cost per QALY was between $8159 and $10 244. If intravitreal saline injection was used as a primary procedure, the overall imputed cost was $5828 to $8098. The cost per line was $2374 to $3299, the cost per line-year saved was $164 to $227, and the cost per QALY was $5458 to $7583. CONCLUSIONS: As a primary procedure, PPV was the most cost-effective therapy in this model. The other treatments had similar costs per QALY saved and compare favorably with costs of therapy for other retinal diseases.


Subject(s)
Fibrinolysin/economics , Fibrinolytic Agents/economics , Health Care Costs/statistics & numerical data , Retinal Diseases/economics , Vitrectomy/economics , Clinical Trials as Topic , Cost-Benefit Analysis , Intravitreal Injections , Markov Chains , Peptide Fragments , Prospective Studies , Quality-Adjusted Life Years , Retinal Diseases/therapy , Retinal Perforations/therapy , Tissue Adhesions/therapy
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