Interim Analysis of Clinical Outcomes with Open versus Closed Conjunctival Implantation of the XEN45 Gel Stent.

OBJECTIVE: To examine the longitudinal postoperative outcomes of open versus closed conjunctiva implantation of the XEN45 gel stent. DESIGN: Retrospective multicenter study. SUBJECTS: One hundred ninety-three patients with glaucoma underwent XEN45 implantation via an open or closed conjunctiva approach. METHODS: Data on patient demographics; diagnoses; preoperative and postoperative clinical data; outcome measures, including intraocular pressure (IOP); use of glaucoma medications; visual acuity; and complications were collected. Statistical analyses were performed with P < 0.05 as significant. MAIN OUTCOME MEASURES: Failure was defined as < 20% reduction in IOP from the medicated baseline or a IOP of > 21 mmHg at 2 consecutive visits at postoperative month 1 and beyond, the need for subsequent operative intervention or additional glaucoma surgery, or a catastrophic event, such as loss of light perception. Eyes that had not failed by these criteria and were not on glaucoma medications were considered complete successes. Overall success was defined as those who achieved success either with or without topical medications. RESULTS: Patients were followed for an average of 17 months. Complete success was achieved in 42.5% and 24.7% of the open and closed groups, respectively (P = 0.01). Overall success was achieved in 64.2% and 37.0% of the open and closed groups, respectively (P < 0.001) at the last follow-up. Bleb needling was performed in 12.4% of eyes in the open group compared with 40% of eyes in the closed group. An IOP spike of ≥ 10 mmHg was twice as likely to occur in the closed group compared with the open group during the postoperative period (40% vs. 18%; P = 0.001). CONCLUSIONS: Implantation of XEN45 with opening of the conjunctiva resulted in a lower IOP with greater success and lower needling rate compared with those achieved with the closed conjunctiva technique. Similar rates of postoperative complications and vision loss were noted in each group. Although both procedures provide substantial IOP reduction, the open technique appears to result in higher success rates and fewer postoperative interventions. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Retrobulbar tube shunt: anterior chamber to back of the eye (A2B) efficacy in glaucomatous eyes with uncontrolled IOP.

PURPOSE: The purpose of this study is to examine the efficacy and safety of a commercial model of the retrobulbar shunt, anterior chamber to back of the eye (A2B), in lowering intraocular pressure (IOP) and medication requirements after the failure of all other IOP-lowering therapies, including trabeculectomy with antimetabolites and tube shunt procedures. METHODS: This is a single-site, prospective, nonrandomized concept study. Patients with prior failed tube shunts, or moderate to severe glaucoma refractory to treatment, were included. All subjects underwent A2B shunt implantation. Each subject's IOP and number of medications were assessed from baseline at each time interval using paired t tests. Primary outcome measures were IOP and glaucoma medication use pre- and postoperatively. Complete success is defined as (1) IOP ≤ 21 mmHg; (2) IOP reduction from baseline of ≥ 20%; (3) no reoperation for glaucoma; (4) no loss of light perception vision; (5) no chronic hypotony defined as IOP ≤ 5 mmHg; and (6) no use of supplemental glaucoma medication. "Qualified success" required satisfaction of the same criteria as "complete success" but with the use of supplemental glaucoma medication at 6 months. RESULTS: Nineteen eyes of 19 patients (mean age 39.5 ± 6.4) were followed for 6 months. The mean IOP (mmHg±SEM) at 6 months dropped from baseline of 35.3 ± 2.3 to 18.5 ± 1.1(- 16.8, - 47%; p < 0.0001). The mean number of glaucoma medications (±SEM) at 30, 90, and 180 days decreased from a baseline of 2.4 ± 0.3 to < 0.3 at each interval (p < 0.0002). The complete and qualified success rates at 6 months were 46.6% (7/15) and 66.6% (11/15), respectively. The mean number of prior incisional glaucoma surgeries was 3.2. The percent of patients that had previously failed sub-Tenon tube shunt surgeries was 79%. CONCLUSIONS: The A2B shunt is an effective rescue therapy in patients that have failed other IOP-lowering procedures. By shunting aqueous humor into the retrobulbar space, IOP and number of glaucoma medications required were substantially reduced for the 6-month postoperative assessment interval. The intrinsic properties of the retrobulbar space may limit the risk of fibrosis, the principal cause of bleb failure.

Glaucoma Patch Graft Surgery Utilizing Corneas Augmented with Collagen Cross-linking.

PURPOSE: Glaucoma drainage device surgery (GDDS) has gained popularity, with outcomes equivalent to trabeculectomy. Erosion of the tube through the overlying conjunctiva may occur in 5%-10% of eyes. Donor corneal tissue has been used as a patch graft for GDDS. MATERIALS AND METHODS: This was a prospective proof of concept study in 10 patients undergoing GDDS. From patients undergoing endothelial keratoplasty, the donor tissue (approximately 300 µ in thickness) was placed epithelial side down in a well and was allowed to soak in riboflavin solution (VibeX, Avedro, Waltham, MA, USA) for 15 min. This anterior corneal lenticule received 8 mW/cm2 ultraviolet (UV) irradiation applied for 15 min (total energy of 7.2 J/cm2). Each lenticule was then bisected and utilized for the two study participants. The tissue was sutured over the tube during the GDDS and then was covered with recipient conjunctiva as per the usual technique. Representative graft tissues were fixed and examined to determine the depth of cross-linking effect. The patients were followed for 1 year. RESULTS: Histology revealed no apparent demarcation line in the cross-linked grafts; this supported a full-thickness cross-linking treatment effect. There were no intra- or postoperative complications attributed to the graft tissue. No patient developed erosion or exposure of the tube during the 1-year follow-up. CONCLUSIONS: UV-riboflavin cross-linking of the corneal tissue patch graft material appears to be a safe modification when used in GDDS and warrants ongoing study. This method of patch graft can replace other costy methods used with GDD.

Effect of Chloral Hydrate Sedation on Intraocular Pressure in a Pediatric Population.

PURPOSE: To determine the effect of oral chloral hydrate (CH) sedation on intraocular pressure (IOP) in an outpatient pediatric population. DESIGN: Prospective, noncomparative case series. METHODS: Children aged 1 month to 5 years undergoing CH sedation for ocular imaging/evaluation at a tertiary eye hospital were included. IOP was measured using an Icare tonometer prior to sedation (in some, not all), at 25 minutes after sedation, and then every 10 minutes until sedation completion. Change in IOP over time was assessed using mixed model linear regression to account for correlation of IOP readings. RESULTS: A total of 112 children were enrolled, 50.9% were female, and mean age was 2.1 (standard deviation [SD]: 1.3) years. Of the total, 83 (74.1%) participants had IOP measurement attempted prior to sedation, with 64 having presedation IOP completed. Among those completing presedation IOP, 46.9% were asleep/calm, and the rest (53.1%) were slightly/more distressed (IOP did not differ by level of agitation). Those with and without presedation IOP available had similar demographics and health status (P > .05). Heart rate, respiratory rate, and oxygen saturation all declined after sedation (P < .001). The mean dose of CH administered was 80.9 (SD: 13.2) mg/kg, and sedation was deemed "adequate" in 97.3% after a single dose. Mean IOP among those with presedation IOP was 19.5 mm Hg and, although not significant, declined to 18.7 mm Hg at 25 minutes (P = .12). There was no trend toward further decline in IOP over time (P > .05). CONCLUSIONS: CH sedation for outpatient pediatric ophthalmic procedures as administered in this prospective assessment had no impact on IOP.

Chloral Hydrate Administered by a Dedicated Sedation Service Can Be Used Safely and Effectively for Pediatric Ophthalmic Examination.

PURPOSE: To determine safety and efficacy of oral chloral hydrate sedation (CHS) for outpatient pediatric ophthalmic procedures. DESIGN: Prospective, interventional case series. METHODS: Setting: King Khaled Eye Specialist Hospital. SUBJECTS: Children aged 1 month to 5 years undergoing CHS for ocular imaging/evaluation. PROCEDURES: Details on chloral hydrate dose administered, sedation achieved, vital signs, and adverse events were recorded. OUTCOME MEASURES: Primary outcome was percentage of patients with a sedation level ≥ 4 at 45 minutes post chloral hydrate administration. Secondary outcomes were time from sedation to discharge and adverse events, including changes in vital signs following chloral hydrate administration. RESULTS: A total of 324 children were recruited with a mean age of 2.2 (SD: 1.3) years and mean weight of 10.9 (SD: 3.3) kg. Adequate sedation was obtained with a mean chloral hydrate first dose of 77.4 (SD: 14.7) mg/kg in 306 (94.4%) patients, with an additional 6 patients (1.9%) achieving adequate sedation with a second dose (overall adequate sedation: 96.3%). Mean reductions in heart rate, respiratory rate, and oxygen (O2) saturation from pre-sedation to 25 minutes post-sedation were 11.7 (SD: 14.3) beats per minute, 1.2 (SD: 2.4) breaths per minute, and 0.81% (SD: 1.2%), respectively (P < .001 for all). In multivariable regression, odds of remaining sedated 45 minutes after chloral hydrate administration were 2.53 times higher for American Society of Anesthesiologists (ASA) class II or III patients than for ASA class I (95% confidence interval [CI]: 1.11-5.78, P = .03), 1.03 times higher per mg increase in initial dose of chloral hydrate (95% CI: 1.01-1.06, P = .006), and 2.70 times higher per unit increase in number of planned procedures (95% CI: 1.63-4.47, P < .001). Three patients developed minor adverse events: 2 cases of O2 desaturation and 1 paradoxical reaction, none requiring significant intervention. Patients were discharged a median of 90 minutes after chloral hydrate administration. CONCLUSION: Chloral hydrate administered by a dedicated sedation service, as in this prospective assessment, can be used safely and effectively for outpatient pediatric ophthalmic procedures.

Retinal Detachment After Cyclophotocoagulation in a Child with Knobloch Syndrome.

Knobloch syndrome (KS) is typically characterized by high myopia, vitreoretinal degeneration, retinal detachment, and macular abnormalities. We report a case of glaucoma in KS, which represents the fourth reported case and the first description of the retinal events after the glaucoma procedure. Retinal detachment followed standard cyclophotocoagulation procedure for glaucoma in a 2-month-old boy. Ophthalmologists should be aware of the possibility of retinal detachment from any ocular intervention in patients with KS.

Intraocular Pressure Outcomes Following Transscleral Diode Cyclophotocoagulation Using Long and Short Duration Burns.

PURPOSE: The purpose of this study was to compare outcomes of transscleral diode cyclophotocoagulation using short duration (SD) versus longer duration (LD) treatment. PATIENTS AND METHODS: Data were collected retrospectively on patients with glaucoma who underwent cyclophotocoagulation with LD (4000 ms) treatment with variable power ≤1000 mW versus SD using 1500 ms with variable power ≤2000 mW. The outcome measures included: intraocular pressure (IOP) at 12 months, decrease in number of antiglaucoma medications, complications and visual acuity (VA) at the final follow-up visit. RESULTS: There were 71 patients and 70 patients in the SD and LD groups, respectively. The mean IOP±SD pretreatment baseline was 33±10 versus 36±10 mm Hg for SD and LD groups, respectively (P>0.05). At 1 year postoperatively, the IOP decreased significantly in both groups (16.7 vs. 17.4 mm Hg for SD and LD, respectively; P<0.0001). This decrease in IOP was comparable between groups (P=0.5). The average number of IOP lowering medications were 2.5 and 2.9 at baseline in the SD and LD groups, respectively, and decreased to 1.3 in both groups (P=0.83). The mean LogMAR VA decreased significantly from 1.87 at baseline to 1.96 at 1 year in the SD group (P=0.276), and 2.03 to 2.3 (P≤0.001) in the LD group, this change was comparable (0.19; P=0.075) between the 2 groups. Complications were also comparable. CONCLUSIONS: Both LD and SD burns during cyclophotocoagulation effectively lowered IOP at 1 year. Neither treatment resulted in a greater reduction of IOP. LD treatment appeared to result in a decrease in VA and greater postoperative inflammation.

Periocular skin hyperpigmentation in children treated with prostaglandin analogues.

PURPOSE: To report periocular skin hyperpigmentation related to prostaglandin analogue (PGA) use in children with glaucoma. METHODS: This cross-sectional study examined children treated with PGA for at least 6 months between June 2013 and December 2013. The pigmentation scores of the upper eyelids, lower eyelids and cheek were recorded with a chromameter. Hyperpigmentation was defined as a positive difference in scores between the cheek and the upper/lower eyelid. The influence of age, baseline skin pigmentation, duration of PGA, type of PGA and mono- or multitherapy on hyperpigmentation were evaluated. Subjective grading of pigmentation on standardized face photographs and the parent's perception of hyperpigmentation were also recorded. A P value of <0.05 was considered significant. RESULT: A total of 55 patients were included. Hyperpigmentation of the upper and lower eyelids occurred in all eyes. Subjectively, 26 (47%) eyes had mild and 14 (26%) moderate hyperpigmentation. The upper eyelid showed significantly greater hyperpigmentation than the lower eyelid (P = 0.00004). Chromameter measurements overlapped with pigmentation grading on photographs. The type of and duration of PGA use, PGA mono- or multidrug therapy or baseline skin pigmentation had no effect on the grade of hyperpigmentation. CONCLUSIONS: PGA use for more than 6 months was associated with periocular skin hyperpigmentation that was greater in the upper eyelid versus lower eyelid. All variables examined failed to show a relationship with the grade of hyperpigmentation.