Efficacy and safety of deep sclerectomy with uveoscleral implant plus collagen matrix implant overcoming the superficial scleral flap in glaucoma surgery.

AIM: To assess the efficacy and safety of non-penetrating deep sclerectomy (NPDS) with uveoscleral implant plus subconjunctival and intrascleral collagen matrix overcoming the superficial scleral flap lips (modified deep sclerectomy technique, DS) and minimal use of mitomycin C in glaucoma surgery. METHODS: A retrospective review of 47 consecutive glaucoma patients who underwent NPDS with DS between January 2017 and May 2018. Best-corrected visual acuity, intraocular pressure (IOP), post-operative need for glaucoma medications, visual field mean deviation (MD), re-interventions, needling revisions and laser goniopuncture were noted. Absolute success was defined as IOP≤18 mm Hg without topical medication. Relative success was defined as the same criteria but with the addition of any antihypertensive medication. IOP over 18 mm Hg on two consecutive follow-up visits was considered as a failure. RESULTS: Fifty-two eyes of 47 patients were evaluated. Mean preoperative IOP was 25.37±6.47 mm Hg, and decreased to 15.04±4.73 at 12mo and 12.21±4.1 at 24mo (all P<0.0001). Requirement for topical medications dropped from a mean of 3.06±0.25 per patient to 0.51±0.99 and 1.11±1.23 respectively after 12 and 24mo (all P<0.0001). No medications were required in 45.5% of patients after 24mo. Relative and absolute success rate at 24mo were 85.5%±5% and 48.5%±7.4%, respectively. CONCLUSION: DS is a safe and effective non-penetrating glaucoma surgery variation. It aims to retain the patency of all pathways created for aqueous humor drainage: the intrascleral bleb, the supraciliary space and the open communication between intrascleral and subconjunctival compartments.

Ocular Decompression Retinopathy with Macular Edema after Deep Sclerectomy with Intrascleral Implantation.

We report a case of ocular decompression retinopathy (ODR) with macular edema, diagnosed by optical coherence tomography, after a deep sclerectomy (DS) with an intrascleral implant, resolved with medical therapy 6 months later. The medical literature reports that in 14% of patients suffering from ODR, a pars plana vitrectomy was required, and 15% of patients had a poor final visual acuity. An otherwise healthy 75-year-old man with high myopia and a primary open-angle glaucoma, with previous intraocular pressure (IOP) of 24 mm Hg, underwent a DS with intrascleral implant without complications. The patient suffered postoperatively from ODR with macular edema that required medical therapy with nonsteroidal anti-inflammatory eye drops (Nepafenac® 0.3%) for a period of 6 months. ODR is an infrequent complication that may occur after any surgical or medical procedure that causes a sudden IOP decrease. The presence of macular edema is only reported in 5% of cases and can occur in patients who report a decreased visual acuity, commonly associated with a retinal hemorrhage. We have described a case of ODR with macular edema after DS with intrascleral implant. Although ODR is considered to cause a low level of morbidity, in some patients this may not be the case.

Supraciliary versus intrascleral implantation with hema implant (Esnoper V-2000) in deep sclerectomy: a multicenter randomized controlled trial.

PURPOSE: To compare the supraciliary versus intrascleral implantation of the hema implant (Esnoper V-2000) in terms of the efficacy and safety in nonpenetrating deep sclerectomy (NPDS). PATIENTS AND METHODS: Prospective, randomized, unmasked, competitive and multicenter clinical trial. Eighty-three eyes from 83 patients suffering from open-angle glaucoma (40 males, 43 females) were enrolled and followed up for 12 months. Main outcome measures were best-corrected visual acuity (BCVA), intraocular pressure (IOP), perimetry (mean defect, MD and Visual Field Index, VFI), pachymetry, number of antiglaucoma medications and analysis of blebs according Moorfields Bleb Grading. RESULTS: The IOP was significantly reduced in both groups from 23.74 ± 6.9 mmHg (implant sutured to the sclera, group 1) and 23.46 ± 6.47 mmHg (implant placed in the suprachoroidal space, group 2) to 15.43 ± 4.27 mmHg (p < 0.001) and 14.62 ± 3.64 mmHg (p < 0.001), respectively. There were no statistically significant differences in mean IOP values between the groups a year after the surgery (p = 0.581). BCVA did not show statistical differences in comparison with baseline (p = 0.09, group 1; p = 0.42, group 2). The mean number of antiglaucoma medications was reduced in both groups from 2.58 ± 0.04 and 2.68 ± 0.02 before the surgery to 0.32 ± 0.76 and 0.24 ± 0.66 after surgery. CONCLUSION: Nonpenetrating deep sclerectomy using hema implant (Esnoper V-2000) is safe and effective regardless of the positioning of the implant. We achieved IOP decrease and reduction in antiglaucoma medications during the first year after surgery without significant differences between both techniques.

Two-year Results After Deep Sclerectomy With Nonabsorbable Uveoscleral Implant (Esnoper-Clip): Surgical Area Analysis Using Anterior Segment Optical Coherence Tomography.

PURPOSE: To report 2-year results of deep sclerectomy (DS) with mitomycin C and the uveoscleral implant Esnoper-Clip (AJL Ophthalmics, Álava, Spain), a nonabsorbable hema implant, and the morphologic analysis of the surgical area with anterior segment optical coherence tomography (AS-OCT). MATERIALS AND METHODS: In total, 41 eyes of 41 patients with medically uncontrolled open angle glaucoma who underwent DS with the uveoscleral implant were included in this prospective interventional study. Patients were recruited and selected sequentially. All patients were followed at least for 12 months and 36 of them for 24 months. Absolute success was defined as intraocular pressure (IOP)≤18 mm Hg and ≥20% of IOP reduction without topical medication. Relative success was defined with the same criteria but with the addition of any antihypertensive medication. Primary outcomes were IOP decrease in the postoperative stage. Secondary outcomes were number of medication, best-corrected visual acuity changes, rate of goniopuncture, needle revision, and AS-OCT analysis of the bleb area. AS-OCT analysis, using Visante OCT, was performed at 1, 12, and 24 months. RESULTS: Absolute success rate was 68.3% at 12 months and 61.1% at 2 years. Relative success was 78.0% and 71.4%, at 12 and 24 months, respectively. A significant IOP decrease was observed, from 27.3±6.3 to 14.9±4.4 mm Hg at 12 months and 15.3±5.2 mm Hg at 24 months (P<0.001). There was also a significant reduction in the number of medications, dropping from a mean of 2.5 to 0.28 one year and 0.36 two years after the surgery (P<0.001). Main postoperative complications were transient: 4 eyes with seidel phenomenon at 24 hours (10.3%), 3 hyphema (7.7%), and 1 choroidal detachment (2.6%). Mean intrascleral space height, measured by AS-OCT, was 0.78 mm and it showed a significant positive correlation with IOP at 12 months. Neodymium-doped yttrium aluminium garnet laser goniopuncture was performed in 25 eyes (61%) at 12 months and in 27 (66.8%) by 24 months. CONCLUSIONS: DS with the uveoscleral implant is a safe and effective procedure to lower IOP in open angle glaucoma patients. IOP reduction is maintained over 2 years and is correlated to the postoperative height of the intrascleral bleb. Supraciliary implantation reduces intrascleral lake dependency, being a simultaneous drainage alternative to the subconjunctival pathway.

Deep Sclerectomy With a New Nonabsorbable Uveoscleral Implant (Esnoper-Clip): 1-Year Outcomes.

PURPOSE: To report the safety and the effectiveness of deep sclerectomy (DS) with a new nonabsorbable uveoscleral hema implant (Esnoper-Clip) designed to increase trabecular and uveoscleral outflow and to achieve higher intrascleral blebs. MATERIALS AND METHODS: Twenty-seven eyes of 27 patients with open-angle glaucoma, who underwent DS with an Esnoper-Clip implant, were included in this study. All patients were followed up after 12 months. RESULTS: A significant decrease in intraocular pressure was observed after surgery, changing from a preoperative mean of 26.6±5.2 mm Hg to a postoperative mean of 15.3±5 mm Hg (P<0.001) at 12 months. There was also a significant reduction in the number of glaucoma drugs needed, varying from 2.5 per patient to 0.3 (P<0.001) 1 year after surgery. The main intrascleral lake height and volume at 12 months was 0.7±0.1 mm and 3.9±1.3 mm, respectively. No intraoperative complications occurred. The main postoperative complications were a positive Seidel test result at 24 hours in 2 eyes (7.4%), hyphema in 2 eyes (7.4%), and choroidal detachment in 1 eye (3.7%). All these complications resolved successfully. The need for additional mitomycin-C injections was recorded in 4 eyes (14.8%), twice in 2 of them. Twelve eyes (44.4%) underwent postsurgical Nd:YAG laser goniopuncture with a mean time between surgery and this procedure of 4.3 months. Mean intraocular pressure after Nd:YAG laser goniopuncture decreased from 19.2 to 15.5 mm Hg (P<0.001). CONCLUSION: DS with an uveoscleral hema implant (Esnoper-Clip) is a safe and effective technique for the management of open-angle glaucoma.