Pravin U. Dugel

Two-year outcomes of the ranibizumab for edema of the mAcula in diabetes (READ-2) study.

OBJECTIVES To determine the long-term effects of ranibizumab (RBZ) in patients with diabetic macular edema (DME). DESIGN Prospective, randomized, interventional, multicenter clinical trial. PARTICIPANTS One hundred twenty-six patients with DME. METHODS Subjects were randomized 1:1:1 to receive 0.5 mg RBZ at baseline and months 1, 3, and 5 (group 1), focal or grid laser photocoagulation at baseline and month 3 if needed (group 2), or a combination of 0.5 mg RBZ and focal or grid laser at baseline and month 3 (group 3). Starting at month 6, if retreatment criteria were met, all subjects could be treated with RBZ. MAIN OUTCOME MEASURES The mean change from baseline in best-corrected visual acuity (BCVA) at month 24. RESULTS After the primary end point at month 6, most patients in all groups were treated only with RBZ, and the mean number of injections was 5.3, 4.4, and 2.9 during the 18-month follow-up period in groups 1, 2, and 3, respectively. For the 33 patients in group 1, 34 patients in group 2, and 34 patients in group 3 who remained in the study through 24 months, the mean improvement in BCVA was 7.4, 0.5, and 3.8 letters at the 6-month primary end point, compared with 7.7, 5.1, and 6.8 letters at month 24, and the percentage of patients who gained 3 lines or more of BCVA was 21, 0, and 6 at month 6, compared with 24, 18, and 26 at month 24. The percentage of patients with 20/40 or better Snellen equivalent at month 24 was 45% in group 1, 44% in group 2, and 35% in group 3. Mean foveal thickness (FTH), defined as center subfield thickness, at month 24 was 340 μm, 286 μm, and 258 μm for groups 1, 2, and 3, respectively, and the percentage of patients with center subfield thickness of 250 μm or less was 36%, 47%, and 68%, respectively. CONCLUSIONS Intraocular injections of RBZ provided benefit for patients with DME for at least 2 years, and when combined with focal or grid laser treatments, the amount of residual edema was reduced, as were the frequency of injections needed to control edema. FINANCIAL DISCLOSURE(S) Proprietary or commercial disclosure may be found after the references.

Pars plana vitrectomy without scleral buckle for pseudophakic retinal detachments

OBJECTIVE To report the anatomic and visual results of primary pars plana vitrectomy (PPV) without scleral buckling to repair primary rhegmatogenous retinal detachments in pseudophakic eyes. DESIGN Nonrandomized, prospective, comparative clinical trial. PARTICIPANTS Two hundred eighty-three consecutive patients (294 eyes) with pseudophakia, peripheral retinal tears, and new rhegmatogenous retinal detachments were treated according to the surgery protocol. INTERVENTION Patients underwent PPV with fluid-gas exchange and endolaser to repair the retinal detachment. Two hundred sixty-four patients (275 eyes) were followed from 6 months to 6 years and 8 months with an average follow-up of 19 months. MAIN OUTCOME MEASURES Reattachment of the retina and visual outcome were compared to previously published studies. RESULTS Of 97 eyes with a macula-attached rhegmatogenous retinal detachment, 88 eyes (91%) were reattached with a single operation, and of the 178 eyes with a macula-detached retinal detachment, 153 (86%) eyes were reattached with a single operation. In 241 (88%) of 275 eyes, the retina was reattached with a single operation, and in 265 (96%) of 275 eyes, the retina was ultimately reattached with subsequent operations. The median initial visual acuity was 20/300, and the median final visual acuity was 20/40. The rate of reattachment with one operation was similar for eyes with an anterior chamber intraocular lens (91%) and for eyes with a posterior chamber intraocular lens (88%). Refractive error measurements obtained in 81 eyes were essentially unchanged. The mean change in refractive error was -0.15 diopter. Seventeen eyes (6%) developed macular puckers requiring surgery, 46 eyes (17%) developed cystoid macular edema, and 6 eyes (2%) developed full-thickness macular holes. CONCLUSION Primary PPV with fluid-gas exchange and laser is a safe, effective method to repair primary pseudophakic retinal detachments. The anatomic reattachment rate and the visual acuity obtained with this technique appear to be at least as good as those reported in the literature for scleral buckling, PPV with scleral buckling, and pneumatic retinopexy.

Rapidly Progressive Outer Retinal Necrosis in the Acquired Immunodeficiency Syndrome

Two patients, both seropositive for the human immunodeficiency virus, developed rapidly progressive retinal necrosis associated with a systemic herpes zoster infection. The retinitis in these patients was characterized by primary involvement of the outer retina, with sparing of the inner retina and retinal vasculature until late in the disease process; a rapidly progressive course; poor response to intravenous acyclovir; and development of rhegmatogenous retinal detachment. In one of the patients, the retinitis was initially multifocal. Electron microscopy of a retinal biopsy specimen from one of the patients demonstrated virus particles consistent with a herpesvirus, and polymerase chain reaction disclosed herpesvirus in a retinal biopsy specimen of the other patient. This entity may represent a distinct form of acute retinal necrosis that is seen in immunocompromised individuals.

Macular pucker removal with and without internal limiting membrane peeling: pilot study

OBJECTIVE To investigate results of macular pucker surgery with and without internal limiting membrane (ILM) peeling. DESIGN Retrospective noncomparative interventional case series. PARTICIPANTS Forty-four consecutive patients underwent pars plana vitrectomy to remove an idiopathic macular pucker by two surgeons from June 1999 to July 2000. INTERVENTION During the vitrectomy, one surgeon removed only the macular epiretinal membrane (24 patients), whereas the other surgeon removed the macular epiretinal membrane and then performed an additional ILM peeling (20 patients). MAIN OUTCOME MEASURES Visual acuity and recurrence of macular pucker. RESULTS Twenty-four (55%) patients underwent pars plana vitrectomy without ILM peeling, and 20 patients (45%) underwent pars plana vitrectomy with ILM peeling. Visual acuity improved or was unchanged in 79% of operated eyes without ILM peeling and 100% of operated eyes with ILM peeling (P = 0.01). Visual acuity improved 5 or more lines in 25% of operated eyes without ILM peeling and 30% of operated eyes with ILM peeling. At the final visit, 21% of eyes without ILM peeling at the initial surgery showed postoperative recurrent macular pucker or persistent contraction to the ILM, whereas none of the eyes with ILM peeling had evidence of this. CONCLUSIONS This pilot study provides evidence that peeling of the ILM during macular pucker surgery may not have deleterious effects.

Short-term Outcomes of 23-gauge Pars Plana Vitrectomy

PURPOSE To report the initial experience and safety profile of 23-gauge pars plana vitrectomy (PPV) in eyes undergoing vitreoretinal surgery. DESIGN Retrospective, multicenter, consecutive, interventional case series. METHODS The inclusion criteria for this study included eyes that underwent primary, 23-gauge PPV for various indications including, but not limited to, epiretinal membrane, nonclearing vitreous hemorrhage, idiopathic macular hole, and rhegmatogenous retinal detachment (RD), and postoperative follow-up of at least 12 weeks. Exclusion criteria included history of prior vitrectomy, glaucoma filtration surgery, or administration of gas at expansile concentrations. Main outcome measures included best-corrected Snellen visual acuity (VA), intraocular pressure (IOP), intraoperative complications, and postoperative complications. RESULTS Ninety-two patients met the inclusion criteria. The overall VA improved from 20/238 (range, 20/25 to hand motions [HM]) preoperatively to 20/82 (range, 20/20 to HM) postoperatively (P < .001). Each surgical indication experienced a statistically significant VA improvement. Intraoperative complications included retinal tears observed in two eyes (2.2%). Sclerotomy sutures were required intraoperatively in two eyes (2.2%). Postoperative complications included postoperative day 1 hypotony in six eyes (6.5%), a retinal tear in one eye (1.1%), and a recurrent RD in one eye (1.1%). No cases of endophthalmitis were observed. CONCLUSIONS Intraoperative and postoperative complications were rare in this series of 23-gauge vitrectomy. Postoperative day 1 hypotony was the most common complication observed. All cases of postoperative hypotony resolved at postoperative week 1 without intervention. Retinal tear or detachment was an uncommon complication in the intraoperative and postoperative settings. Postoperative endophthalmitis was not noted in this case series.

A Comparison of Retrobulbar versus Sub-Tenon's Corticosteroid Therapy for Cystoid Macular Edema Refractory to Topical Medications

OBJECTIVE The objective is to compare the effectiveness of retrobulbar and posterior sub-Tenons injection of corticosteroids for treatment of post-cataract cystoid macular edema that was refractory to topical medications. DESIGN A retrospective study was performed. PARTICIPANTS A total of 48 patients (49 eyes) with post-cataract cystoid macular edema refractory to topical medications was studied. INTERVENTION Patients received either a single retrobulbar injection (18 eyes) or 3 biweekly posterior sub-Tenons injections (31 eyes) of corticosteroids. MAIN OUTCOME MEASURES Patients were observed for clinical resolution of the cystoid macular edema, visual acuity, and intraocular pressure. RESULTS Both treatment methods resulted in significant improvement in visual acuity. The posterior sub-Tenons group had a visual improvement from 20/92 pretreatment to 20/50 post-treatment (P = 0.0001) with a median follow-up of 12 months. The retrobulbar group had a visual improvement from 20/97 pretreatment to 20/58 post-treatment (P = 0.035) with a median follow-up of 10 months. The visual improvement was not significantly different between the two groups. The average intraocular pressure increased from a pretreatment level of 14.1 mmHg to a high of 17.7 mmHg (P < 0.00005) in the sub-Tenons group. The average intraocular pressure increased from 15.1 mmHg to a high of 17.6 mmHg (P = 0.04) in the retrobulbar group. CONCLUSIONS Cystoid macular edema that persists after treatment with topical medications may improve after retrobulbar or posterior sub-Tenons corticosteroid injections. There was no significant difference in outcome between the two treatment groups.

Evaluation of the safety and performance of an applicator for a novel intravitreal dexamethasone drug delivery system for the treatment of macular edema.

Purpose: Evaluation of safety and performance of an applicator-inserted dexamethasone drug delivery system. Methods: Patients with clinically observable macular edema were randomized to receive 700 μg dexamethasone drug delivery system via a pars plana incisional placement (n = 10) or a 22-gauge applicator insertion (n = 20). Outcome measures included assessment of procedure duration, the postinsertion wound, adverse events, intraocular pressure, and best-corrected visual acuity at baseline and days 1, 7, 14, 30, 60, 90, and 180. Results: Both procedures were well tolerated and none of the patients in the applicator group required sutures to close the insertion wound. The overall incidence of ocular adverse events was less in the applicator group (13/19; 68.4%) than the incisional group (9/10; 90%), although the difference was not statistically significant in this pilot study. Vitreous hemorrhage occurred in two patients in the incisional group and none in the applicator group. Increases in intraocular pressure were less frequent in the applicator group (3/19; 15.8%) than the incisional group (3/10; 30%). No cases of endophthalmitis or retinal detachment occurred in either group. The percentage of patients achieving improvement in visual acuity of ≥15-letters at Day 90 was similar in both groups; 40% (8/20) in the applicator group and 30% (3/10) in the incisional group. Conclusion: The dexamethasone drug delivery system applicator system performed well, allowing safe, effective, and sutureless intravitreal placement of 700 μg dexamethasone drug delivery system.

Infectious multifocal choroiditis in patients with acquired immune deficiency syndrome

PURPOSE The purposes of this study are to determine the incidence of infectious opportunistic choroiditis in patients with the acquired immune deficiency syndrome (AIDS), to study the association of these choroidal infections with systemic dissemination, and to investigate the life expectancy and cause of death in patients with infectious opportunistic choroiditis. METHODS A total of 470 eyes of 235 consecutive autopsies of patients with AIDS were examined by histopathologic methods. The clinical charts and autopsy reports of these patients were subsequently reviewed for presence of systemic dissemination of various infectious agents. RESULTS Of the 235 patients, 18 were found to have infectious choroiditis. The etiologic agents found were: Cryptococcus neoformans, Pneumocystis carinii, Mycobacterium tuberculosis, Histoplasma capsulatum, Candida, Aspergillus fumigatus, Toxoplasma gondii, and Mycobacterium avium-intracellulare. In 15 of these 18 patients, the cause of death was considered to be due to systemic dissemination of the organism causing the choroiditis. Only 4 of the 18 cases of infectious choroiditis were diagnosed during life, and the survival time of these patients after diagnosis was only 25 days. Five of the 18 patients also were found to have cytomegalovirus (CMV) infection of the retina. CONCLUSION Multifocal choroiditis due to endogenous infectious emboli in patients with AIDS reflects systemic dissemination and localization of infectious agents predominantly in the choriocapillaris. Early diagnosis and treatment are imperative and may be life-saving.

Pars Plana Vitrectomy for Intraocular Inflammation-related Cystold Macular Edema Unresponsive to Corticosteroids A Preliminary Study

PURPOSE To determine the role of pars plana vitrectomy in patients with intraocular inflammation-related cystoid macular edema that is unresponsive to corticosteroids. METHODS Eleven eyes of nine patients underwent a standard three-port pars plana vitrectomy. The primary indication was intraocular inflammation-related cystoid macular edema that was unresponsive to oral, sub-Tenons, and topical corticosteroids. Preoperative follow-up ranged from 20 months to 144 months (average, 70 months). Postoperative follow-up ranged from 3 months to 108 months (average, 21 months). RESULTS Seven eyes (64%) improved 4 or more lines of Snellen visual acuity within 4 weeks. Two eyes (18%) remained unchanged and 2 eyes (18%) worsened. Cystoid macular edema improved by clinical examination and fluorescein angiography in 9 eyes (82%) and by clinical examination alone in 2 eyes (18%). No intraoperative complications were noted. Postoperative complications consisted of cataract formation in 1 eye (9%), glaucoma in 2 eyes (18%), and epiretinal membrane formation in 1 eye (9%). CONCLUSION Pars plana vitrectomy may have a role in the treatment of intraocular inflammation-related cystoid macular edema that fails to respond to corticosteroids. The subgroup of patients who benefit most remains to be identified.

Oct-based interpretation of the vitreomacular interface and indications for pharmacologic vitreolysis.

Purpose: To review the role of optical coherence tomography (OCT) in diagnosis and management of vitreomacular disease and the impact of OCT on potential uses of ocriplasmin, a new pharmacologic vitreolysis agent recently approved by the U.S. Food and Drug Administration for the treatment of symptomatic vitreomacular adhesion. Methods: Analysis of current literature regarding OCT in diagnosis and management of vitreomacular interface disease. Results: Posterior vitreous detachment is typically a nonpathologic age-related event. Anomalous posterior vitreous detachment emerges when the vitreous cortex fails to cleanly detach from the macula, optic nerve, or other adherent sites. Focal vitreomacular adhesion is a nonpathologic anatomical designation associated with perifoveal posterior vitreous detachment but normal retinal morphology on OCT. Vitreomacular traction is a pathologic consequence of persistent vitreous attachment with structural disturbance of the macular retina visible on OCT. Full-thickness macular holes are foveal defects continuous through all retinal layers to the retinal pigment epithelium. Vitreomacular traction and macular hole with focal vitreomacular adhesion are indications for pharmacologic vitreolysis. Conclusion: Noninvasive high-resolution OCT imaging has transformed the understanding of vitreomacular interface disease. Careful evaluation of the vitreomacular interface with OCT has increased in importance with the introduction of ocriplasmin for vitreomacular adhesion associated with symptomatic anatomical retinal changes.