The gonio scratch study: methodology of a multicenter clinical trial establishing a new minimally invasive glaucoma surgery.

There are numerous surgical procedures for glaucoma. Minimally invasive glaucoma surgery is becoming popular; however, the disadvantage is the high incidence of anterior chamber hemorrhage. Heavy bleeding can also lead to increased intraocular pressure (IOP) postoperatively. Gonio scratch is a surgical procedure that improves aqueous humor outflow by rubbing off deposits on the trabecular meshwork with a Diamond Dusted Sweeper. As the conjunctiva and trabecular meshwork are not incised, no postoperative bleeding is expected, and the IOP spike will be minimal. We designed this study to determine the efficacy and safety of gonio scratch. This is an on-going multicenter, prospective, clinical trial. Patients who are scheduled for glaucoma surgery with or without cataract surgery are being enrolled. A total of 80 eyes will be recruited in the Hiroshima University Hospital, Miyoshi Eye Clinic, Yokoyama Retina Clinic, and Kusatsu Eye Clinic. All patients will undergo gonio scratch. When combined with cataract surgery, gonio scratch is performed after the intraocular lens is inserted. The primary study endpoint is the change in IOP from baseline to 1 year after surgery. The secondary endpoints are complications, number of glaucoma medications, surgical time, and changes in visual acuity and the visual field. This study protocol was approved by the institutional review board of Hiroshima University. The trial results will be shared with the scientific community at international conferences and by publication in a peer-reviewed journal. Trial registration number is jRCTs062200003.

One-year results of a multicenter controlled clinical trial of triamcinolone in pars plana vitrectomy.

PURPOSE: To evaluate the 1-year results of using triamcinolone acetonide (TA) in pars plana vitrectomy (PPV). DESIGN: Multicenter prospective controlled clinical trial. SETTING AND STUDY POPULATION: the study population comprised 774 eyes from patients treated at eight Japanese hospitals, among which 391 eyes underwent TA-assisted PPV and 383 control eyes underwent conventional PPV. The patients were assigned to the two groups using a single-blind quasi-randomization approach within the participating clinical centers. INTERVENTION: intra-operative use of TA to aid visualization of the vitreous. MAIN OUTCOME MEASURES: changes of visual acuity, post-operative complications (including additional surgery), and adverse events occurring within 1 year of the operation were compared between the TA-PPV group and the conventional PPV group. RESULTS: The visual acuity improved over time, and no significant differences were found between the two groups (log-rank versus TA, P = 0.98 for improvement, P = 0.26 for deterioration). The logistic regression model also showed that the intra-operative use of TA was not a significant factor for the improvement of visual acuity [P = 0.91, odds ratio (OR) = 1.10, 95% confidence interval (95%CI) = 0.860-1.183)] after adjustments for age, gender, and diagnosis. Intra-operative TA was not a significant factor for the need for additional surgery (log-rank test P = 0.45, logistic regression test P = 0.35, OR = 1.23, 95%CI = 0.797-1.911]. No serious adverse events related to surgery were observed. CONCLUSIONS: This 1-year follow-up study of a controlled clinical trial showed that TA-assisted PPV had neither a positive nor a negative effect on visual acuity, the incidence of additional surgeries, or adverse events compared with conventional PPV.

[Case of fungal endophthalmitis developed after subtenon injections of triamcinolone acetonide].

BACKGROUND: We report a case of fungal endophthalmitis which developed after subtenon injections of triamcinolone acetonide (TA). CASE: A 63-year-old man had Graves' ophthalmopathy. He had received subtenon injections of TA in his left eye. He was admitted to Kimura Eye & Internal Medicine Hospital because of a subconjunctival abscess with inflammatory cells in the anterior chamber. Although we treated it as a suspected bacterial infection at the first visit, it deteriorated rapidly. Because prolonged antibiotics and antifungal therapy seemed ineffective, we performed diagnostic surgery. The lower sclera around the subtenon injections of TA was hard and thick, and a white spotty lesion and retinal detachment were seen on the lower retina. A culture of the Tenon sac showed filamentous fungus. After the surgery the subconjunctival abscess recurred because intravenous antifungal therapy had been discontinued. A culture of the abscess identified Alternaria sp. The subconjunctival abscess, thickened sclera, and retinal exudate were limited to the region of the sub-Tenon injection of TA, We conclude that the sclera had been permeated by hyphae of Alternaria sp. CONCLUSION: In this case, critical infection was caused by the sub-Tenon injections of TA.

Reduced incidence of intraoperative complications in a multicenter controlled clinical trial of triamcinolone in vitrectomy.

PURPOSE: To evaluate the benefits and potential complications of using triamcinolone acetonide (TA) in pars plana vitrectomy (PPV). DESIGN: Multicenter, prospective, controlled clinical trial. PARTICIPANTS: In total, 774 patients from 8 Japanese hospitals were enrolled, with 391 patients undergoing TA-assisted PPV and 383 control patients undergoing conventional PPV. INTERVENTION: Intraoperative use of TA to aid visualization of the vitreous. MAIN OUTCOME MEASURES: The incidence of intraoperative complications, including retinal breaks, was evaluated. Early postoperative complications, intraocular pressure (IOP), and adverse events occurring within 3 months of the operation were also monitored. RESULTS: The incidence of both retinal breaks and intraoperative retinal detachment was significantly lower in TA-assisted PPV than in conventional PPV. Retinal breaks were seen in 34 eyes (8.7%) undergoing TA-assisted PPV compared with 54 eyes (14.1%) undergoing conventional PPV (odds ratio [OR], 0.603; 95% confidence interval [CI], 0.381-0.955; P = 0.031). Retinal detachment was seen in only 3 eyes (0.8%) in which TA was used compared with 14 eyes (3.7%) in which TA was not used (OR, 0.204; 95% CI, 0.057-0.727; P = 0.014). In total, 388 eyes in the TA-assisted PPV group (99.2%) and 374 eyes in the conventional PPV group (97.6%) were followed up for 3 months after the operation. Although the mean postoperative IOPs were comparable in both groups, antiglaucoma eye drops were used more frequently by patients in the TA-assisted group than by those in the conventional PPV group (OR, 1.673; 95% CI, 1.126-2.484; P = 0.011). No serious adverse events, such as endophthalmitis or retinal degeneration, were observed in either group. CONCLUSIONS: Intraoperative use of TA reduced the incidence of retinal breaks and retinal detachments in eyes undergoing PPV. There were no serious adverse events related to the intraoperative use of TA. Although antiglaucoma eye drops were required more frequently after TA-assisted PPV than after conventional PPV, IOP was well-controlled in both groups.

Incidence of acute endophthalmitis after triamcinolone-assisted pars plana vitrectomy.

PURPOSE: To report the incidence of acute endophthalmitis after triamcinolone acetonide-assisted pars plana vitrectomy (PPV). DESIGN: A retrospective multicenter interventional case series collected over 23 months. METHODS: We retrospectively reviewed the charts of all patients who underwent triamcinolone-assisted PPV at seven academic clinical centers or eye hospitals from January 2002 to November 2003. RESULTS: Of a total of 1,886 cases, only 1 case showed acute endophthalmitis due to Staphylococcus epidermidis (0.053%). No other cases showed any signs of postoperative endophthalmitis. CONCLUSION: Intraoperative use of triamcinolone during PPV is not a high risk factor for acute endophthalmitis.

Residual vitreous cortex after surgical posterior vitreous separation visualized by intravitreous triamcinolone acetonide.

OBJECTIVE: To visualize the residual vitreous cortex (VC) on the retinal surface after surgical posterior vitreous separation (PVS) during a pars plana vitrectomy (PPV), especially in patients with diabetic retinopathy. DESIGN: Case-control study. PARTICIPANTS: Patients with proliferative diabetic retinopathy (PDR), diabetic macular edema (DME), branch retinal vein occlusion (BRVO), and rhegmatogenous retinal detachment (RRD). METHODS: A triamcinolone acetonide (TA)-assisted vitrectomy was performed on patients with the following diseases: PDR (40 eyes), DME (26 eyes), BRVO (11 eyes), and RRD (17 eyes). Eyes with no apparent preoperative posterior vitreous detachment were enrolled in this study. After performance of surgical PVS, the residual VC was visualized as a white gel highlighted by TA. Based on this finding, the residual VC pattern was then divided into 3 groups: (1) diffuse type (VC was diffusely present in the temporal vascular arcade), (2) focal type (a small island of VC was left), and (3) no residual VC. A multivariate analysis using analysis of variance was performed regarding the residual VC pattern, disease type, age, and the 3 different surgeons. MAIN OUTCOME MEASURES: Each surgeon determined the type of residual VC during the operation, and the results were confirmed by a postoperative review of the videotape records judged by the other 2 surgeons. RESULTS: Eighty percent of the PDR eyes demonstrated the diffuse type; 10%, the focal type; and 10%, no residual VC. Fifty-eight percent of the eyes with DME demonstrated the diffuse type; 19%, the focal type; and 23%, no residual VC. Eighteen percent of the BRVO eyes showed the diffuse type; 24%, the focal type; and 59%, no residual VC. Thirty percent of the RRD eyes showed the diffuse type; 30%, the focal type; and 40%, no residual VC. A multivariate logistic regression analysis showed that PDR was a predictor of the diffuse type of residual VC in comparison to RRD (odds ratio = 8.42, 95% confidence interval = 2.07-34.3). Neither age nor the surgeon was a significant factor for a specific type of residual VC. CONCLUSIONS: Diabetic eyes more often demonstrated the diffuse type of residual VC, even after surgical PVS. This information may be valuable for surgeons performing a PPV on patients with diabetic retinopathy.

Two cases of intraoperative anterior chamber angle observation using ophthalmic endoscope in viscocanalostomy.

PURPOSE: To report endoscopic findings in the anterior chamber angle during injection of viscoelastic material in viscocanalostomy (VCS). DESIGN: Observational case reports. METHODS: Two cases of primary open-angle glaucoma were treated with VCS and cataract surgery. Immediately before and during injection of viscoelastic material into Schlemm's canal, the anterior chamber angle was observed using an ophthalmic endoscope. RESULTS: In both cases, we observed viscoelastic material in Schlemm's canal and leakage of viscoelastic material and blood from Schlemm's canal into the anterior chamber away from the injection site of the viscoelastic material. In one case, indocyanine green-stained viscoelastic material was not in Schlemm's canal the day after surgery. CONCLUSIONS: In VCS, Schlemm's canal was filled and was disrupted after viscoelastic material injection. Disruption of the inner wall of Schlemm's canal and juxtacanalicular connective tissues may contribute to the intraocular pressure reduction associated with VCS.