Time to clinically significant visual acuity gains after ranibizumab treatment for retinal vein occlusion: BRAVO and CRUISE trials.

PURPOSE: To assess time to first achievement of clinically significant visual acuity (VA) gains from baseline in patients with retinal vein occlusion (RVO) receiving ranibizumab versus sham treatment. DESIGN: Post hoc analyses of 2 phase 3 clinical trials assessing efficacy and safety of ranibizumab in patients with branch RVO (Ranibizumab for the Treatment of Macular Edema following Branch Retinal Vein Occlusion: Evaluation of Efficacy and Safety [BRAVO] study; NCT00061594) and central RVO (Ranibizumab for the Treatment of Macular Edema after Central Retinal Vein Occlusion Study: Evaluation of Efficacy and Safety [CRUISE]; NCT00056836) over 12 months. PARTICIPANTS: Seven hundred eighty-nine patients (BRAVO, n = 397; CRUISE, n = 392). INTERVENTION: Randomization to monthly intraocular ranibizumab injections (0.3 mg/0.5 mg) or sham. After 6 monthly injections (treatment period), patients meeting prespecified criteria received as-needed (pro re nata [PRN]) ranibizumab at their assigned dose (sham patients, ranibizumab 0.5 mg) through month 12 (observation period). BRAVO patients meeting specific eligibility criteria could receive rescue laser treatment once during the treatment and once during the observation periods. MAIN OUTCOME MEASURES: Time to first gain of 15 letters or more from baseline, analyzed using Kaplan-Meier methods. To evaluate the effect of delaying ranibizumab treatment, sham patients' VA data also were analyzed, with month 6 considered as baseline to assess vision gains during the 6 months of receiving ranibizumab PRN. RESULTS: Median time to first 15-letter or more gain from baseline was 12.0 (sham), 4.8 (ranibizumab 0.3 mg), and 4.0 months (ranibizumab 0.5 mg) in BRAVO and 12.2, 5.9, and 5.2 months, respectively, in CRUISE. The cumulative proportion of patients who had ever gained 15 letters or more from baseline by month 12 was 50% (sham), 68% (ranibizumab 0.3 mg), and 71% (ranibizumab 0.5 mg) in BRAVO and 42%, 61%, and 66%, respectively, in CRUISE. After 6 months of ranibizumab PRN treatment, a cumulative 10.8% (BRAVO) and 26.2% (CRUISE) of initially sham-treated patients ever gained 15 letters or more. CONCLUSIONS: This retrospective analysis shows that more than 50% of patients treated with monthly ranibizumab achieved clinically significant vision gains during the initial 6 months of treatment, which largely were maintained using PRN treatment to 12 months. In comparison, less than 50% of patients initially randomized to sham (and later receiving ranibizumab 0.5 mg PRN treatment) ever achieved clinically significant vision gains. These results suggest that initiating treatment immediately after diagnosis may provide the greatest vision gains. The potential benefits of early treatment should be evaluated further in prospective clinical studies.

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.

Severe eye injuries in the war in Iraq, 2003-2005.

PURPOSE: To document the incidence and treatment of patients with severe ocular and ocular adnexal injuries during Operation Iraqi Freedom. DESIGN: Retrospective hospital-based observational analysis of injuries. PARTICIPANTS: All coalition forces, enemy prisoners of war, and civilians with severe ocular and ocular adnexal injuries. METHODS: The authors retrospectively examined severe ocular and ocular adnexal injuries that were treated by United States Army ophthalmologists during the war in Iraq from March 2003 through December 2005. MAIN OUTCOME MEASURES: Incidence, causes, and treatment of severe ocular and ocular adnexal injuries. RESULTS: During the time data were gathered, 797 severe eye injuries were treated. The most common cause of the eye injuries was explosions with fragmentation injury. Among those injured, there were 438 open globe injuries, of which 49 were bilateral. A total of 116 eyes were removed (enucleation, evisceration, or exenteration), of which 6 patients required bilateral enucleation. Injuries to other body systems were common. CONCLUSIONS: Severe eye injuries represent a significant form of trauma encountered in Operation Iraqi Freedom. These injuries were most commonly caused by explosion trauma.

Feasibility of telerobotic microsurgical repair of corneal lacerations in an animal eye model.

We evaluated the feasibility of telerobotic microsurgical repair of corneal lacerations. The telerobotic microsurgical device consisted of a Robotic Slave Micromanipulator Unit (RSMU) coupled to a Telepresence Surgical System (TeSS). Five mm central full-thickness corneal wounds were fashioned in five enucleated rabbit eyes and repaired remotely using the telerobotic system. Five additional eyes were also repaired by hand using a standard technique. The primary outcome measure was creation of a watertight seal. All eyes in both groups maintained an intraocular pressure (IOP) of 25 mm Hg without leak. The mean repair time was 80 min (range 50-130) with telerobotic surgery compared to 8 min (range 7-9) by hand. Histological evaluation showed that suture placement was similar in robotically assisted repair and manual repair. Subjectively, the telerobotic system provided adequate three-dimensional visualization of the surgical field. The study showed that a surgeon could close standardized corneal wounds using the telerobotic system. The potential benefits of remote eye surgery include improved access, surgical teleconsultation and telementoring.

Intraocular foreign body injuries during Operation Iraqi Freedom.

OBJECTIVE: To evaluate the number of intraocular foreign body (IOFB) injuries that occurred in Operation Iraqi Freedom, and to determine the cause of injury, the type of foreign body, and the associated injuries to other body systems. DESIGN: Retrospective, noncomparative, interventional case series. PARTICIPANTS: Fifty-five United States military personnel with an IOFB injury during Operation Iraqi Freedom. INTERVENTION: Pars plana vitrectomy, foreign body removal, and additional surgical procedures as the clinical situation dictated. MAIN OUTCOME MEASURES: Cause of injury, size of corneal/scleral laceration, number of foreign bodies, type of foreign body, time to foreign body removal, visual acuity, number of enucleations, and injuries to other body systems. RESULTS: The foreign body was caused by a propelled explosive in 20 patients (36%) and a nonpropelled explosive in 31 patients (56%), and the cause of the foreign body was not known in 4 patients (7%). The size of the laceration of the cornea and/or sclera averaged 5.4 mm (range, 0.2-18). There were an average of 1.7 foreign bodies in the injured eye (range, 1-6). The size of those foreign bodies measured ranged from <1 mm to 12 x 14 mm. The most common type of foreign body was metal (68%), followed by glass (14%), stone/cement (14%), bone (5%), and cilia (3%). The time from injury to foreign body removal averaged 20.6 days (range, 0-90). No cases of endophthalmitis were seen. The most common associated injury was to the upper extremity, face, lower extremity, and neck. CONCLUSIONS: Unlike trauma in the civilian sector, IOFB injuries in a military setting tend to be caused by explosive devices, which often result in multiple foreign bodies and simultaneous injuries to other body systems. Because of the lack of availability of specialty care in the combat theater, there is often a delay in removal of the foreign body.

Large-spot size transpupillary thermotherapy for the treatment of occult choroidal neovascularization associated with age-related macular degeneration.

OBJECTIVE: To describe the outcome of patients with occult choroidal neovascularization in age-related macular degeneration treated with transpupillary thermotherapy. DESIGN: Prospective, nonrandomized, nonmasked case series. METHODS: All patients with age-related macular degeneration with a predominantly occult choroidal neovascular membrane and an initial visual acuity of 20/400 or better were offered treatment using transpupillary thermotherapy. The treatment consisted of using a diode laser, a spot size of about 3000 to 6000 micro m delivered over 60 seconds, and a power of 600 to 1000 mW. MAIN OUTCOME MEASURES: A stable, improved, or worsened visual acuity and the need for additional treatment. RESULTS: Sixty-nine patients were treated. All patients have been followed up for at least 6 months. At the 6-, 9-, and 12-month follow-up visits, 71% of patients have stable or improved visual acuity and 29% have lost 2 or more lines of visual acuity on the Snellen letter chart. CONCLUSION: Large-spot size transpupillary thermotherapy is effective in stabilizing the visual acuity in those patients who have occult choroidal neovascularization due to age-related macular degeneration.

Teleophthalmology in the evaluation of ocular trauma.

OBJECTIVE: The objective of this investigation is to evaluate the efficacy of teleophthalmology in the assessment of anterior segment and ocular adnexal trauma using digital imaging devices. METHODS: Eight ocular injuries were created in an animal model. Two separate photographers of different skill levels photographed each injury using four different cameras. The images were transmitted via the Internet and were reviewed by 83 ophthalmologists masked as to the injury, camera, and photographer. The ability to make the correct diagnosis was evaluated. RESULTS: The correct diagnoses were made most consistently for the full-thickness eyelid laceration (96%), corneoscleral laceration with uveal prolapse (92%), partial-thickness eyelid laceration (86%), and hyphema (80%). The correct diagnoses were made less frequently with the intraocular foreign body (10%), normal eye (39%), and corneal foreign body (46%). CONCLUSIONS: With the current technology, it appears that teleophthalmology can be used with some reliability to assist with the diagnosis of certain ocular injuries. However, improvements in technology will be necessary before the diagnosis of most intraocular injuries will be able to be done on a consistent basis.

Homocysteine: a risk factor for retinal venous occlusive disease.

PURPOSE: Recent studies have shown a relationship between elevated levels of homocysteine and vascular disease including cerebrovascular accidents and myocardial infarctions. We evaluated patients with a recent retinal vein occlusion to determine if there was an associated elevation of homocysteine. DESIGN: Age and gender matched case-controlled study. PARTICIPANTS: Twenty patients with retinal venous occlusive disease within the previous 6-month period and 40 control patients without retinal venous occlusive disease were enrolled in the study. METHODS: Twenty patients with a history of retinal vein occlusion underwent laboratory testing to determine serum homocysteine levels. In addition, a health survey was completed and several laboratory tests relating to vascular disease including cholesterol were checked. Two control groups were selected. The first group included patients with diabetes and no history of retinal vascular occlusive disease. The second control group included nondiabetic patients who also had no prior history of retinal vascular occlusive disease. MAIN OUTCOME MEASURES: The main parameter measured in this study is fasting homocysteine. RESULTS: Fifteen of 20 patients (75%) with retinal vein occlusion disease had an elevated fasting serum homocysteine level, whereas only 5 of 40 control patients (13%) had an abnormal homocysteine level (P < 0.0005). CONCLUSIONS: Patients with retinal venous occlusive disease have higher levels of homocysteine, which may serve as a modifiable risk factor.