Hypotony Failure Criteria in Glaucoma Surgical Studies and Their Influence on Surgery Success.

PURPOSE: Review hypotony failure criteria used in glaucoma surgical outcome studies and evaluate their impact on success rates. DESIGN: Systematic literature review and application of hypotony failure criteria to 2 retrospective cohorts. PARTICIPANTS: A total of 934 eyes and 1765 eyes undergoing trabeculectomy and deep sclerectomy (DS) with a median follow-up of 41.4 and 45.4 months, respectively. METHODS: Literature-based hypotony failure criteria were applied to patient cohorts. Intraocular pressure (IOP)-related success was defined as follows: (A) IOP ≤ 21 mmHg with ≥ 20% IOP reduction; (B) IOP ≤ 18 mmHg with ≥ 20% reduction; (C) IOP ≤ 15 mmHg with ≥ 25% reduction; and (D) IOP ≤ 12 mmHg with ≥ 30% reduction. Failure was defined as IOP exceeding these criteria in 2 consecutive visits > 3 months after surgery, loss of light perception, additional IOP-lowering surgery, or hypotony. Cox regression estimated failure risk for different hypotony criteria, using no hypotony as a reference. Analyses were conducted for each criterion and hypotony type (i.e., numerical [IOP threshold], clinical [clinical manifestations], and mixed [combination of numerical or clinical criteria]). MAIN OUTCOME MEASURES: Hazard ratio (HR) for failure risk. RESULTS: Of 2503 studies found, 278 were eligible, with 99 studies (35.6%) lacking hypotony failure criteria. Numerical hypotony was predominant (157 studies [56.5%]). Few studies used clinical hypotony (3 isolated [1.1%]; 19 combined with low IOP [6.8%]). Forty-nine different criteria were found, with IOP < 6 mmHg, IOP < 6 mmHg on ≥ 2 consecutive visits after 3 months, and IOP < 5 mmHg being the most common (41 [14.7%], 38 [13.7%], and 13 [4.7%] studies, respectively). In both cohorts, numerical hypotony posed the highest risk of failure (HR, 1.51-1.21 for criteria A to D; P < 0.001), followed by mixed hypotony (HR, 1.41-1.20 for criteria A to D; P < 0.001), and clinical hypotony (HR, 1.12-1.04; P < 0.001). Failure risk varied greatly with various hypotony definitions, with the HR ranging from 1.02 to 10.79 for trabeculectomy and 1.00 to 8.36 for DS. CONCLUSIONS: Hypotony failure criteria are highly heterogenous in the glaucoma literature, with few studies focusing on clinical manifestations. Numerical hypotony yields higher failure rates than clinical hypotony and can underestimate glaucoma surgery success rates. Standardizing failure criteria with an emphasis on clinically relevant hypotony manifestations is needed. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Minimally invasive micro sclerostomy (MIMS) procedure in the treatment of open-angle glaucoma.

BACKGROUND: To evaluate the safety and efficacy of the Minimally Invasive Micro Sclerotomy (MIMS) procedure in the management of uncontrolled open-angle glaucoma. METHODS: A prospective, open-label, single-arm clinical evaluation with intra-subject comparisons performed at the Ophthalmologic Center after S.V. Malayan, Yerevan, Armenia. Included were adults with primary open-angle glaucoma (OAG) (N = 114) or exfoliative glaucoma (N = 6) who were uncontrolled (IOP > 21) on tolerated topical medication. Mild (N = 7), moderate (N = 66) and severe (n = 47) cases were prospectively included without preselection. Following subconjunctival Mitomycin C, an ab-interno MIMS procedure was performed alone (N = 100) or combined with phacoemulsification (N = 20). Patients were followed for 52 weeks. Procedure-related complications and adverse events were recorded. Success criteria were defined as -5 < IOP ≤ 21mmHg OR a reduction in IOP of ≥ 20% from baseline with (qualified success) or without (complete success) hypotensive medications. RESULTS: Mean patient age was 69 ± 10.1 years. The mean duration of the procedure was 2:01 ± 0:41 min:sec. Scleral drainage channels were achieved in all cases. No device malfunctions, intraoperative complications, or serious adverse events were reported. Iris plugging of the sclerostomy site and early spikes in IOP were the most common adverse events. The only reason for failure was final IOP > 21 mmHg on tolerated medication. At 52 weeks (n = 93), mean IOP decreased by 38% from baseline (P < 0.001), from 27.9 ± 3.7 to 17.5 ± 5.3 mmHg, a difference of 10.5 mmHg (95% CI: -11.7, -9.3). One-year qualified success was documented in 82.1% (95% CI: 72.9%,89.2%) of the patients and complete success, in 70.5% (60.3-79.4%). 60% (95 CI:49.4%,69.9%) of the patients achieved maximum IOP level of 14 mmHg or at least 30% reduction in IOP. CONCLUSIONS: MIMS procedure is a relatively simple, short and safe minimally invasive bleb-forming procedure. Its efficacy, as found in this short-term evaluation, lends it suitable for mild and moderate uncontrolled open-angle glaucoma patients. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04503590 2019-05-29.

Wedge-Shaped Pars Plana Sclerotomies: Is It Still an Actuality in the Era of Microincision Vitrectomy?

PURPOSE: To describe and evaluate the effectiveness of wedge-shaped sclerotomies to close 25-gauge and 23-gauge transconjunctival pars plana vitrectomies. MATERIALS AND METHODS: This prospective, consecutive, interventional study examined 50 eyes of 50 patients who underwent 25-gauge and 23-gauge vitrectomy with wedge-shaped sclerotomies. RESULTS: The number of eyes requiring a wedge shape for sclerotomy closure and sclerotomies requiring sutures was collected. Three eyes had hypotony on Day 1. No statistically significant difference was observed between preoperative intraocular pressure and postoperative intraocular pressure on Days 15 and 30. No postoperative complications were observed during the follow-up period. CONCLUSION: The wedge-shaped sclerotomy is a simple, fast, and effective technique that does not require extra surgical materials and could be applied to microincision vitrectomy.

NONPERFORATING INTRASCLERAL STABBING FOR SUTURELESS 23G SCLEROTOMY CLOSURE.

PURPOSE: The need for suturing leaking sclerotomies have not been eliminated completely in transconjunctival sutureless vitrectomy (TSV). This study aims to describe a novel technique for 23-gauge (G) sclerotomy closure in TSV surgery and discuss its effectiveness. MATERIALS AND METHODS: Two hundred and thirty cases of 180 patients who underwent 23G TSV with various diagnoses were included to the study. Cases with connective tissue diseases, thin sclera, and significant conjunctival and scleral scarring were excluded. Nonperforating intrascleral stabbing (NIS) was performed to leaking 23G sclerotomies (n = 650) and 27G chandeliers (n = 84). Demographics, rate of sclerotomy closure with NIS procedure, the need for suturing, and complications of the procedure were recorded. RESULTS: The overall success of NIS was found to be 91.0% in sclerotomies. Although 9.1% of sclerotomies required sutures, 592 of the 650 sclerotomies could be closed with NIS procedure ( P < 0.001). Nonperforating intrascleral stabbing procedure helped close 98.8% of leaking 27G chandeliers. An average of 1.28 ± 0.52 NIS attempts were needed for successful sclerotomy closure. Closure of sclerotomies with the NIS technique were somewhat related to the location of the sclerotomy, history of TSV and NIS, duration of TSV, and type of endotamponade. Hypotonia and choroidal detachment were seen in one case. No additional interventions were needed to normalize intraocular pressure in any case. Subconjunctival hemorrhage happened to be the leading complication of the procedure. CONCLUSION: NIS procedure seems as a practical, reproducible, cost-effective, and uncomplicated approach, which significantly reduces the need to suture 23G sclerotomies. Further studies are required.

New Releasable Nonabsorbable Polypropylene 8.0 Suturing Technique for Sclerotomy Sealing in 23-Gauge Vitrectomy.

PURPOSE: We propose a new releasable 8.0 polypropylene suture for leaking sclerotomies at the end of vitrectomy. Characteristic of this suture is that it can be easily removed the day after surgery at the slit-lamp examination. METHODS: Patients undergoing 23-gauge pars plana vitrectomy with the need for at least 2 sclerotomy sutures and having a preoperative Ocular Surface Disease Index score <12 were consecutively allocated to sealing with either polyglactin 910 absorbable suture (VY GROUP) or nonabsorbable 8.0 polypropylene releasable suture (PR GROUP). Evaluation of adverse events, Ocular Surface Disease Index score, and conjunctival hyperemia (through the Efron scale) was performed at 1, 7, and 30 days postoperatively. RESULTS: Both methods effectively sealed sclerotomies. PR GROUP showed a significantly lower Ocular Surface Disease Index score and lower degree of conjunctival hyperemia at both 7 and 30 days follow-up. The Ocular Surface Disease Index score decreased significantly after 7 days in PR GROUP while in VY GROUP improved at 30 days postoperatively. PR GROUP showed a lower degree of conjunctival hyperemia both at 7 and 30 days follow-up. CONCLUSION: Polypropylene 8-0 releasable sutures proved to be effective in 23-gauge pars plana vitrectomy wound sealing while inducing less ocular surface inflammation and patient discomfort compared with the standard polyglactin 910 suture.

Rotational extraction of incarcerated iris (REII): a slit lamp technique to reduce incarcerated iris after nonpenetrating deep sclerectomy for glaucoma.

PURPOSE: Iris incarceration is a complication of glaucoma filtering surgery that often requires surgery. We describe a technique for reduction of incarcerated iris at the slit lamp, dubbed rotational extraction of incarcerated iris (REII). A retrospective analysis of visual function and intraocular pressure (IOP) was done in patients treated with REII after nonpenetrating deep sclerectomy. METHODS: We retrospectively evaluated a cohort of patients who received REII for iris incarceration after nonpenetrating deep sclerectomy for glaucoma. IOP (applanation) and visual acuity (VA) were measured day-of, and 1, 3, 6, and 12 months post-REII. Adverse events were recorded. Kaplan-Meier survival analysis was done with definitions of IOP control at 15, 18, and 21 mmHg. RESULTS: Forty-one eyes of 41 patients were treated with REII. Median time to iris incarceration from glaucoma surgery was 50 days (range 1-1906). Mean pre-REII IOP ± SD was 33.7 ± 14.1 mmHg, which reduced to 11.5 ± 6.1 mmHg day-of. LogMAR VA was 0.72 ± 0.8 log units at baseline and was unchanged at 12 months (P = 0.53). Survival analysis demonstrated varying efficacy depending on the definition of success. 79.0 to 92.2% of eyes achieved IOP control immediately after REII, 39.5 to 71.1% at 1 month, 26.3 to 52.6% at 3 months, 21.1 to 44.3% at 6 months, and 10.5 to 38.0% at 12 months. Nearly half (47.4%) of eyes required a tube shunt by 12 months. CONCLUSION: REII may be a safe, minimally invasive slit lamp procedure that can reduce incarcerated iris and delay more invasive intervention for 3-6 months in most eyes.

Intrascleral hydration for 23-Gauge Pars Plana Vitrectomy Sclerotomy Closure.

PURPOSE: To describe and evaluate the effectiveness of a new technique to close 23-gauge sclerotomies in transconjunctival pars plana vitrectomy. MATERIALS AND METHODS: A prospective, consecutive, interventional study of 90 eyes of 90 patients who underwent 23-gauge pars plana vitrectomy with the introduction of the new sealing technique was conducted. The 23-gauge sclerotomies were hydrated with a 30-gauge needle inserted in the scleral stroma near the scleral opening. RESULTS: A total of 90 eyes of 90 patients were recruited in the study. The number of the eyes requiring suture for sclerotomy closure was 3.3% (3 of 90), and the sclerotomies requiring suture were 1.4% (4 of 270). Three eyes had hypotony on Day 1. No statistically significant difference was registered between preoperative intraocular pressure and postoperative intraocular pressure on Days 15 and 30. No leaking of endotamponade bubble filling was noticed on Day 1. No postoperative complications were registered during the follow-up period. CONCLUSION: The intrascleral stroma hydration is a simple and fast technique that does not require extra surgical materials.

Cataract and glaucoma combined surgery: XEN® gel stent versus nonpenetrating deep sclerectomy, a pilot study.

BACKGROUND: To compare the efficacy of phacoemulsification (PKE) combined with nonpenetrating deep sclerectomy (NPDS) with mitomycin C (MMC) versus XEN® gel stent with MMC. METHODS: In this nonrandomized, retrospective, comparative, single-center pilot study, 105 consecutive eyes of 75 patients with uncontrolled primary open-angle glaucoma (POAG) and cataract who underwent PKE combined with either XEN implantation (n = 47) or NPDS (n = 58) between May 2013 and November 2018 were included. The primary outcome was complete success at 9 months, which was defined as intraocular pressure (IOP) ≤18, 15 or 12 mmHg without treatment; qualified success was IOP ≤18, 15 or 12 mmHg with antiglaucoma medications. Secondary outcome measures included the number of antiglaucoma medications, visual acuity (VA), and postoperative adverse events. RESULTS: Using the 18 mmHg threshold, complete or qualified success was achieved in 69.6 and 89.1% in the PKE + XEN group, and 63.8 and 89.7% in the PKE + NPDS group (p = .54 and p = .93), respectively, at 9 months. The mean IOP decreased from 20.8 ± 6.8 mmHg to 16.2 ± 2.8 mmHg in the PKE + XEN group (p < .001, 18.9% mean drop), and from 21.5 ± 8.9 mmHg to 14.9 ± 3.9 mmHg in the PKE + NPDS group (p < .001, 25.6% mean drop). Best-corrected VA significantly improved (p < .001) in both groups. The mean number of antiglaucoma medications was significantly reduced from 2.66 ± 1.1 to 0.49 ± 1.0 in the PKE + XEN group (p < .001) and from 2.93 ± 0.9 to 0.69 ± 1.2 in the PKE + NPDS group (p < .001). CONCLUSIONS: The XEN stent combined with PKE seemed to be as effective and safe as PKE + NPDS at 9 months in this pilot study.

Effect of filtering bleb dimensions on postoperative intraocular pressure in deep sclerectomy with collagen implant: a comparative study.

INTRODUCTION: The mechanisms of intraocular pressure (IOP) lowering in deep sclerectomy (DS) are multiple. Using collagen implants is one of the proposed mechanisms of DS success. It has been established to work via maintenance of subscleral decompression lake. However, the relation to conjunctival bleb formation is not fully established. METHOD: This study is a retrospective review of the records of 40 eyes of 30 patients with chronic open-angle glaucoma. Patients were divided into two groups; 20 eyes with DS using the Ologen implant (group A), and 20 eyes with DS without implant (group B). The records of UBM that was done for all patients 1 and 6 months after surgery were assessed for the extent, height of conjunctival bleb, depth of AC, the presence of intrascleral bleb and presence of collagen implant. RESULTS: Extent and height of conjunctival bleb by UBM in group A at 1 and 6 months were 3.46 ± 0.77 mm, 1.6 ± 0.38 and 3.71 ± 1.24 mm, 1.6 ± 0.64, respectively. In group B, they were 2.4 ± 1.12 mm, 0.99 ± 0.69 and 2.69 ± 1.77 mm, 0.81 ± 0.67 mm, respectively; the difference was statistically significant. Correlation using Pearson's correlation coefficient test showed significant negative correlation between extension of the bleb at 6 months and 3rd month postoperative IOP (r = - 0.447, P value 0.048) and significant negative correlation of the height at 6 months to 5th month IOP (r = - 0.491, P 0.028). CONCLUSION: Using collagen implant in DS significantly increases conjunctival bleb dimensions, which reflects on lower postoperative IOP.

Changes in choroidal thickness and optic nerve head morphology after filtering surgery: nonpenetrating deep sclerectomy versus trabeculectomy.

BACKGROUND: The purpose of this study was to evaluate the changes in choroidal thickness and lamina cribrosa position after nonpenetrating deep sclerectomy (NPDS) and trabeculectomy. METHODS: Twenty-three eyes with glaucoma that required filtering surgery were included (12 NDPS and 11 trabeculectomies) in this prospective observational study. OCT-enhanced depth imaging (OCT-EDI) was used to measure choroidal thickness, prelaminar tissue thickness and lamina cribrosa position before and 7 days and 1 month after surgery. All results are shown as median (interquartile range values). RESULTS: Intraocular pressure (IOP) was significantly lower 1 week after surgery than at baseline (7 (6/10) mmHg vs. 21 (18/26) mmHg; p < 0.001) with a mean 64% decrease. IOP remained significantly lower at 1 month with a 55% mean decrease as compared to baseline (10 (8/12) mmHg; p < 0.001). One week after surgery, the subfoveolar choroidal thickness (SFCT) significantly increased (372 (306/523) µm vs. 317 (227/413) µm; p = 0.04) and the prelaminar tissue (PLT) was significantly thicker (269 (162/360) µm vs. 138 (87/268) µm; p = 0.02) as compared to preoperative measurements. These changes were not statistically significant at one month. There were no differences concerning these parameters between the NPDS and trabeculectomy groups. During the first week, the SFCT increase was correlated with IOP reduction (r = - 0.41; p = 0.04). CONCLUSIONS: OCT-EDI allowed the visualization of structural changes at the level of the optic nerve and choroidal vascularization during acute IOP changes. No difference was observed between NPDS and trabeculectomy concerning these structural modifications.

Bilateral Scheie's procedure with Ophthalmic Viscoelastic Device and 5-Fluorouracil.

INTRODUCTION: The surgical management of glaucoma has evolved over time. CASE REPORT: This report describes the first ever case, to our knowledge, of bilateral Scheie's procedures performed with retention of an ophthalmic viscoelastic device and intraoperative and post-operative 5-fluorouracil injections. DISCUSSION: These procedures have now successfully controlled the intraocular pressure in both of the patient's eyes for more than 17 years.

Comparison of the effect of mitomycin C and bevacizumab-methylcellulose mixture on combined phacoemulsification and non-penetrating deep sclerectomy surgery on the intraocular pressure (a clinical trial study).

PURPOSE: Comparison of the effect of mitomycin C (MMC) versus bevacizumab-methylcellulose mixture (BMM) on combined phacoemulsification and non-penetrating deep sclerectomy surgery on the intraocular pressure in patients with open-angle glaucoma was made. METHODS: The current study is a controlled, randomized, double-blind clinical trial. Thirty-eight patients were enrolled, with a total of 40 eyes, and underwent a combined phacoemulsification and non-penetrating deep sclerectomy surgery from 2016 to 2017. MMC with concentration of 0.2 mg/mL for 2 min was used for 20 eyes before separating the scleral flap, and 0.3 mL of BMM (bevacizumab 1.25 mg incorporated into 2% methylcellulose) was injected subconjunctivally following surgery. The success rate of surgery was categorized as complete, relative and failure. Fisher's exact, Mann-Whitney U and Chi-square tests were employed to data analysis. A p value < 0.05 was supposed significant. RESULTS: Patients had the same distribution in terms of age, sex, type of glaucoma and type of cataract. Patients were followed up for a mean of 6 months. The mean intraocular pressure before surgery in the MMC group was 24.85 ± 2.83 mmHg with 3.2 ± 0.523 anti-glaucoma drugs, which reached 13.75 ± 3.552 mmHg with 0.15 ± 0.489 anti-glaucoma drugs at the latest visit. The average intraocular pressure before surgery in the BMM group was 24.45 ± 2.48 mmHg with 2.9 ± 0.641 anti-glaucoma drugs, which reached 15.40 ± 3.267 mmHg with 0.25 ± 0.55 anti-glaucoma drug at the last follow-up. The intraocular pressure was notably lower in the MMC group than BMM group 6 months after surgery. There was not a significant difference from the aspect of success rate and failure rate among the two groups at the 6-month follow-up (p = 0.135). DISCUSSION: Based on the results of this study, MMC and bevacizumab-methylcellulose both seem to be effective in the success of combined phacoemulsification and non-penetrating deep sclerectomy surgery, but MMC decreases intraocular pressure in patients at 6 months post-surgery.

[The effect of trabeculectomy combined with prophylactic sclerotomy as a treatment of late stage juvenile open angle glaucoma and primary congenital glaucoma patients: a primary observational study].

Objective: To evaluate the outcomes of trabeculectomy combined with a new prophylactic sclerotomy in late stage juvenile open angle glaucoma (JOAG) and primary congenital glaucoma (PCG) patients at high risks of intraoperative and postoperative suprachoroidal hemorrhage (SCH). Method: A retrospective case series study. Thirty-three eyes of 28 JOAG patients and 15 eyes of 12 PCG patients with high risk factors for severe choroidal effusion or SCH were enrolled from November 2006 to April 2012 at Eye and ENT Hospital of Fudan University. The standard trabeculectomy accompanied by prophylactic sclerotomy was performed (video attached). Ophthalmic examinations were performed before and after the surgery. Surgical outcome was assessed in terms of intraocular pressure (IOP), best-corrected visual acuity, optic nerve head cup disc ratio, visual field, and complications. All patients were followed up for at least 1 year. Complete success was defined as an IOP ≥6 mmHg (1 mmHg=0.133 kPa) but ≤18 mmHg without medication. Qualified success was defined as an IOP ≥6 mmHg but ≤18 mmHg with local application of medications. Kaplan-Meier survival curves were drawn for the success rate calculation. Results: The mean age of all 40 patients was (13.2±9.4) years old. And among them, 22 patients were male and 18 patients were female. The mean follow-up time was (31.8±15.9) months. At the postoperative 3(rd) year, the complete success rate was 75.8%, and the qualified success rate was 90.0%. In our case series, one eye had expulsive SCH intraoperatively and two eyes had delayed SCH postoperatively. All of them were successfully saved without further surgery and with no significant damage to visual function. Conclusion: Trabeculectomy combined with prophylactic sclerotomy is a promising technique developed to control IOP in late stage JOAG and PCG patients, which provides a potential intervention to reduce severe consequences of massive choroidal effusion or SCH. (Chin J Ophthalmol, 2019, 55: 347-354).

Central 10-degree visual field change following non-penetrating deep sclerectomy in severe and end-stage glaucoma: preliminary results.

PURPOSE: To report the impact of non-penetrating deep sclerectomy (NPDS) in severe and end-stage glaucoma treatment on the central 10° visual field progression (mean deviation, four central points, foveal threshold) and assess the risk of sudden visual loss. METHODS: Monocenter database study. We reviewed records of 34 eyes with severe or end-stage glaucoma that underwent NPDS between 2009 and 2015, at the National Ophthalmology Center of XV-XX (Paris, France). Severe and end-stage glaucoma were defined according to the Bascom Palmer Modified Glaucoma Staging System classification. All eyes had a constricted visual field < 10° (severe injury by the Humphrey visual field automated (HVFA) 10-2). Visual fields were recorded every 6 months after the procedure. Data from the last visit was used for the statistical analysis. RESULTS: The mean follow-up duration was 29 months (range 6 to 54) and 33 (97%) eyes were followed for more than 1 year. There were no cases of postoperative sudden visual loss. The intraocular pressure (IOP) decreased from 21.9 ± 8.1 to 15.0 ± 5.4 mmHg (P < .001). Twenty-eight (82%) eyes had an IOP < 21 mmHg and 19 (56%) an IOP < 16 mmHg. The MD 10-2 remained stable (- 19.8 ± 7.4 to - 19.4 ± 8.1 dB, non-significant improvement of + 0.4 dB, P = .1). The MD 10-2 slope showed an insignificant improvement of + 0.25 ± 1.8 dB per year (dB/y) (P = 0.1), but this slope was significantly better when the IOP was reduced to < 16 mmHg than when the IOP was ≥ 16 mmHg at the last visit (+ 0.84  1.2 versus - 0.48 ± 2.2 dB/y, P = .05). The mean number of the four central test points with sensitivity ≤ 5 dB and the change in mean sensitivity of the four central field points remained stable. There were no significant changes in the VFI (from 25.4% ± 13 to 25.8% ± 20) and in foveal threshold. CONCLUSION: NPDS appears to provide stability of the central 10° visual field (with a trend towards improvement but non-significant) with no occurrence of "wipe-out" phenomenon and few other complications. Consideration of NPDS in end-stage and severe glaucoma is advisable given its low risk of complications and its considerable IOP decrease with a relative stability of the central visual field.

Prospective evaluation of CO2 laser-assisted sclerectomy surgery (CLASS) with Mitomycin C.

PURPOSE: Our purpose was to evaluate the clinical safety and efficacy of CO2 laser-assisted sclerectomy surgery (CLASS) with Mitomycin C (MMC) in open angle glaucoma (OAG). METHODS: This was a prospective, uncontrolled, interventional case series. All subjects underwent CLASS procedure by a single surgeon. After the dissection of a partial thickness scleral flap, topical MMC 0.2 mg/ml was applied to the sclera and the conjunctiva for 3 min. The CO2 laser with a beam-manipulating system was used to ablate the scleral tissue and expose the Schlemm's canal area. Primary outcomes: intraocular pressure (IOP) change, number of IOP-lowering medicaments change. Adverse events were evaluated as secondary outcomes. RESULTS: Twenty-one eyes of 21 patients underwent the CLASS procedure. Thirteen were primary OAG (62%), two normal pressure glaucoma (10%), three exfoliative glaucoma (14%) and three others secondary OAG. With a mean (SD) follow-up of 15.3 (5.9) months, the IOP changed from 25.4 (6.7) mmHg at baseline to 10.9 (3.4) mmHg al the last visit. Mean reduction of IOP was -14.5 mmHg (95% CI, -17.7 to -11.2, P < 0.001). The median (IQR) number of IOP-lowering medication decreased from 3 (3-3) at baseline to 1 (0-1) at the last visit (P < 0.001). Visual acuity did not change significantly. Adverse events: five eyes (24%) developed iris adhesion to the filtration area that was successfully managed with office-based procedures. In one case (5%), CLASS was converted to trabeculectomy due to intraoperative perforation of the ablated area. There was one case of hypotony maculopathy successfully treated with placement of additional transconjunctival scleral flap sutures. CONCLUSIONS: The CLASS procedure with MMC is clinically safe and effective maintaining a large reduction in IOP and in the number of IOP-lowering medications with a mean follow-up of 15 months. Iris adhesion at the filtrating area warrants further evaluation and possibly reflects the surgeon's learning curve.

A PROSPECTIVE, RANDOMIZED TRIAL COMPARING PLAIN GUT TO POLYGLACTIN 910 (VICRYL) SUTURES FOR SCLEROTOMY CLOSURE AFTER 23-GAUGE PARS PLANA VITRECTOMY.

PURPOSE: To report a prospective, randomized comparative study assessing clinical outcomes of plain gut versus polyglactin 910 (PG910) sutures for sclerotomy closure after 23-gauge pars plana vitrectomy. METHODS: A single-masked, randomized, prospective study was undertaken with 49 eyes of 49 patients undergoing 23-gauge pars plana vitrectomy randomized to sclerotomy closure with either plain gut suture, PG910 (Vicryl) suture or a combination of the two. Assessment was based on both a postoperative pain scale and a standardized assessment of scleral inflammation at each suture site. RESULTS: No wound leakage was noted postoperatively in any patient. Across all groups, scleral inflammation was significantly higher at the PG910 suture sites compared with the plain gut suture sites at both the 1-week (P = 0.04) and 1-month postoperative visits (P < 0.001). Patients with PG910 sutures reported greater pain at the 1-month postoperative visit than those with plain gut sutures (P = 0.018). CONCLUSION: This prospective study suggests improved tolerability and reduced inflammation using plain gut suture compared with an 8-0 PG910 suture to close 23-gauge sclerotomies.

Decompression retinopathy following nonpenetrating deep sclerectomy for primary congenital glaucoma.

BACKGROUND: To describe a unique case of decompression retinopathy manifesting as pre-macular subhyaloid hemorrhage that occurs in a nine-day old child after undergoing a non-penetrating deep sclerectomy for primary congenital glaucoma. CASE PRESENTATION: We report a single case of a 9-day-old boy who was referred to our department of ophthalmology for bilateral buphtalmia and corneal edema. He presented marked elevation of the intraocular pressure in both eyes (22 mmHg and 26 mmHg, in the right eye and left eye respectively) associated with significant optic nerve cupping. Non-penetrating deep sclerectomy was performed for each eye, with effective reduction of the intraocular pressure during the first week postoperatively (11 mmHg and 7 mmHg in the right eye and left eye respectively). The right eye presented an isolated subhyaloid hemorrhage located in the pre-macular area, persisting 3 weeks after the initial surgery and requiring pars-plana vitrectomy to clear the visual axis. This uncommon complication was identified as decompression retinopathy. The intraocular pressure remained controlled in the normal range three years after initial surgery in both eyes, with reversal of optic disc cupping. CONCLUSIONS: Decompression retinopathy is a potential complication after non-penetrating deep sclerectomy in primary congenital glaucoma, requiring prompt treatment strategy to prevent potential organic amblyopia.

The treatment of malignant glaucoma in nanophthalmos: a case report.

BACKGROUND: The management of eyes with nanophthalmos is a dilemma for ophthalmologists due to various complications, especial the eye with malignant glaucoma. We report a case of effective treatment for malignant glaucoma in nanophthalmos. CASE PRESENTATION: An 82-year-old man was performed phacoemulsification in the right eye with normal ocular pressure and nanophthalmos. The surgery was uneventful: an intraocular lens (IOL) was placed and centered in the capsular bag. 2 months later, the patient presented with malignant glaucoma, and the intraocular pressure fluctuated between 18.6 mmHg and 30.8 mmHg with antiglaucoma medications. The patient did not respond to surgical peripheral iridotomy and goniosynechialysis. Then a single treatment with laser peripheral lens posterior capsulotomy and vitreous anterior membranectomy was performed. The intraocular pressure normalized, and the anterior chamber deepened within 24 h. The patient's condition remained stable for 9 months with no further treatment, and his Snellen corrected distance visual acuity was 20/50. The left eye of this patient was treated by combined surgery including phacoemulsification, IOL implantation, anterior vitrectomy, surgical peripheral iridotomy (PI), and goniosynechialysis. No intraoperative or postoperative complications were observed. CONCLUSIONS: This case suggests that it is essential to choose a suitable treatment for nanophthalmos patients to deal with malignant glaucoma and to reduce the incidence of malignant glaucoma.

Subconjunctival PRGF Fibrin Membrane as an Adjuvant to Nonpenetrating Deep Sclerectomy: A 2-Year Pilot Study.

PURPOSE: To evaluate the potential role of the autologous PRGF (plasma rich in growth factors) fibrin membrane in tissue regeneration after glaucoma filtering surgery. MATERIALS AND METHODS: Ten patients with medically uncontrolled primary open-angle glaucoma underwent nonpenetrating deep sclerectomy and were treated with PRGF fibrin membrane as adjuvant. Intraocular pressure reduction was the primary outcome. This variable was measured preoperatively and also at each follow-up visit. Secondary outcomes included the number of antiglaucoma medications, anterior segment optical coherence tomography bleb examination, photographic bleb evaluation, and subjective clinical symptomatology evaluation. RESULTS: The surgical technique showed a significant reduction (p < 0.05) in intraocular pressure in relation to preoperative values at each time of the study, decreasing from 23.3 ± 6.4 to 15.2 ± 4.6 mm Hg at 2 years. Furthermore, the number of antiglaucoma medications consumed showed a significant reduction at the end point of the study compared with the preoperative situation. Optical coherence tomography and photographic filtering bleb variables experienced a progressive reduction during the follow-up. Subjective symptoms showed a reduction from 8.3 ± 4.5 to 4.2 ± 5.3 at 2 years. CONCLUSIONS: PRGF-Endoret treatment could promote ocular surface regeneration after glaucoma surgery, enhancing the surgery success rates and reducing the need for postoperative medications. It is important to highlight that this is a preliminary study and some large clinical studies are necessary to verify these results.

Clinical outcomes after Ex-PRESS glaucoma shunt versus non-penetrating deep sclerectomy: two-year follow-up.

PURPOSE: To compare the two-year outcomes of non-penetrating deep sclerectomy (NPDS) and Ex-PRESS glaucoma shunt. METHODS: A retrospective chart review of patients who had undergone NPDS or Ex-PRESS since 2012 was conducted. Patients were excluded if they had undergone eye surgery other than cataract extraction, were diagnosed with ocular pathology other than glaucoma or had less than two-year follow-up. Pre- and postoperative visual acuity, intraocular pressure (IOP), number of hypotensive drugs and visual fields were recorded, as well as intra- and postoperative complications. RESULTS: Thirty-nine eyes were included in the NPDS and twenty-three eyes in the Ex-PRESS group. There were no differences in baseline IOP and hypotensive drugs, IOP reduction or postoperative IOP-lowering medications between groups. Two years after surgery, IOP decrease compared to baseline was 23.5% with NPDS and 24.8% with Ex-PRESS. Qualified success (a 20% IOP reduction, with IOP ≤ 18 mmHg with or without medication) rates were similar: 53.8 and 69.6% for NPDS and Ex-PRESS. Visual fields progressed in four eyes of the NPDS (10.2%) and in three eyes (8.7%) of the Ex-PRESS group. As regards complications, early hypotony was more frequent after NPDS (9 eyes, 23.1%) than Ex-PRESS (2 eyes, 8.7%), although the difference was not statistically significant. CONCLUSIONS: Both NPDS and Ex-PRESS produce an IOP-lowering effect of approximately 25%. Success rates are similar after both procedures, and both seem to lead to a stabilization of visual loss.