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.

Efficacy and Safety of Sutureless Deep Sclerectomy in Juvenile and Adult Open Angle Glaucoma: 2-Year Outcomes.

PRCIS: Sutureless deep sclerectomy (SDS) achieved significant reduction in primary open angle glaucoma (POAG) and juvenile open angle glaucoma (JOAG). PURPOSE: To assess long-term results of SDS in cases with POAG and JOAG. PATIENTS AND METHODS: A prospective interventional study included 84 eyes of 54 patients underwent SDS with the superficial scleral flap left un-sutured. Changes in intraocular pressure (IOP) were recorded over 2 years. Success was defined according to the world glaucoma association criteria: Criterion A: IOP ≤18 mmHg and IOP reduction ≥30% from the preoperative status without medications [complete success (A1)], with and without medications [qualified success (A2)]. Criterion B: IOP ≤15 mmHg and IOP reduction ≥40% from the preoperative status without medications [complete success (B1)], with and without medications [qualified success (B2)]. RESULTS: There was statistically significant reduction in IOP compared with the preoperative IOP (mean IOP = 26.21± 10.46 mmHg) starting from 1 st postoperative day (mean IOP = 7.18 ± 1.8 mmHg) till the end of follow-up period at 2 years (mean IOP = 15.85± 4.46) ( P < 0.001). Also, number of medications dropped significantly from 3.27 ± 1.14 to 0.82 ± 0.97 at the end of follow up period. At 2 years complete success (A1) was achieved in 57.1% and qualified success (A2) was achieved in 91.6% of cases. Subgroup analysis into males and females, POAG and JOAG showed no statistically significant difference between subgroups regarding IOP reduction. CONCLUSION: SDS is an effective and safe modification to deep sclerectomy in cases with POAG and JOAG.

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.

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.

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.

Safety, efficacy, and timing of Nd:YAG laser goniopuncture after nonpenetrating deep sclerectomy for glaucoma: A retrospective cohort study.

BACKGROUND: Neodymium-doped yttrium aluminum garnet laser goniopuncture is an adjuvant procedure for nonpenetrating deep sclerectomy. We investigated optimal laser goniopuncture timing and the effect of laser iridoplasty on success rates. METHODS: This single-center retrospective cohort study compared intraocular pressure control in patients with early versus late laser goniopuncture after nonpenetrating deep sclerectomy and evaluated the effects of laser iridoplasty pretreatment. A 3-month cut-off was used to define early versus late laser goniopuncture. The primary outcome was the proportion of patients maintaining intraocular pressure control according to definitions of complete (no medications) and qualified (with medications) success at 15, 18, and 21 mmHg thresholds. Data were analyzed using right-censored Kaplan-Meier estimation and log-rank testing. RESULTS: A total of 124 eyes of 124 patients were analyzed. Complete success rates after 3 years were 9.2%, 14.6%, and 23.3% for early laser goniopuncture and 21.8%, 26.0%, and 55.4% for late laser goniopuncture for 15, 18, and 21 mmHg, respectively (all p < .01). Qualified success rates after 3 years were 16.6%, 24.8%, and 40.9% for early laser goniopuncture and 21.5%, 56.1%, and 69.6% for late laser goniopuncture for 15, 18, and 21 mmHg, respectively (p = .096, .0026, .0061). Late laser goniopuncture was associated with decreased risk of iris incarceration and bleb collapse. Iridoplasty pretreatment was not associated with improved outcomes. CONCLUSION: Late laser goniopuncture (3-month cut-off) was associated with better intraocular pressure control and less adverse events than early laser goniopuncture.

Minimally Invasive Micro Sclerostomy (MIMS) Procedure: A Novel Glaucoma Filtration Procedure.

PRCIS: Intermediate-term results suggest that ab interno Minimally Invasive Micro Sclerostomy (MIMS) stent-less subconjunctival filtration procedure is a promising treatment option for patients with open-angle glaucoma (OAG). PURPOSE: MIMS is a novel ab interno, stent-less, subconjunctival filtration procedure. This study set to investigate the safety, performance, and efficacy of MIMS in OAG patients. METHODS: Prospective, open-label, single arm clinical trial with intrasubject comparisons. Study participants were adults with OAG who were candidates for a filtration procedure. Patients were operated by a single surgeon (A.A.) in Chennai, India. Following mitomycin-C pretreatment, ab interno MIMS procedure was performed alone or combined with phacoemulsification surgery. Procedure-related complications and adverse events were assessed. Primary outcomes: patients (%) achieving an intraocular pressure (IOP) ≥5 mm Hg and ≤18 mm Hg, and an IOP reduction of >20% as compared with baseline, with or without hypotensive medications, with no need for recurrent surgery. RESULTS: Twenty-one phacoemulsification-MIMS and 10 standalone MIMS procedures were performed. Mean age was 63.94±6.33 years. Mean duration of MIMS was 1:58±0:25 (min:s). Scleral tunnels were achieved in all cases. No device malfunctions, intraoperative complications, or serious adverse events were reported. Five (16.12%) patients presented with iris clogging 1 to 24 weeks following procedure. Two were treated with laser and 3 required trabeculectomy. Mean IOP change from baseline at 24 weeks was 47.4% (31.2 to 16.4 mm Hg, P<0.0001, n=23). The mean difference was -14.8 mm Hg (95% confidence interval: -17.6, -11.9) with no statistically significant differences between groups. Qualified success was achieved in 21 (84%), 17 (74%), and 13 (93%) after 12, 24, and 52 weeks, respectively. Complete success was achieved in 17 (68%), 13 (57%), and 8 (57%) after 12, 24, and 52 weeks, respectively. CONCLUSIONS: The interim results suggest that MIMS procedure may be a simple and effective surgical option for early OAG patients requiring target IOP in high teens although iris clogging of incision site is the major concern with this procedure.

Hematoma endocapsular: complicación inusual tras facoemulsificación y esclerectomía profunda no perforante / Endocapsular haematoma: An unusual complication of phacoemulsification and non-penetrating deep sclerectomy

CASO CLÍNICO: Varón de 68 años con catarata y glaucoma primario de ángulo abierto no controlado con máximo tratamiento tópico en ojo derecho, intervenido de cirugía combinada de esclerectomía profunda no perforante y facoemulsificación. No presentó complicaciones intraoperatorias, pero en el postoperatorio inmediato acudió por disminución brusca de agudeza visual tras maniobra de Valsalva; se objetivó en la exploración un hematoma endocapsular. En ausencia de resolución espontánea, a los 3meses se realizó capsulotomía posterior con láser neodomio: YAG con mejoría visual inmediata y óptimo control de la presión intraocular. DISCUSIÓN: Se describe el primer caso de hematoma endocapsular como complicación de cirugía no perforante en glaucoma, manejado eficazmente con capsulotomía YAG

CASE REPORT: A 68-year-old male with a cataract and uncontrolled primary open angle glaucoma with maximal tolerated medication underwent non-penetrating deep sclerectomy combined with phacoemulsification surgery in right eye. There were no complications during the procedure, but shortly after the surgery, he lost visual acuity after a Valsalva manoeuvre due to an endocapsular haematoma. Neodymium:YAG laser posterior capsulotomy was performed for the treatment of an unresolving endocapsular haemorrhage at the third month of the follow-up, with immediate visual improvement and optimal control of intraocular pressure. DISCUSSION: To the best of our knowledge, this is the first reported case of endocapsular haematoma as a complication of non-penetrating glaucoma surgery that has been successfully solved by a YAG capsulotomy

Lamellar sclerectomy augmented XEN gel stent glaucoma surgery.

PURPOSE: To describe a surgical technique to optimize XEN gel stent position and its outflow. METHODS: A small 1- to 1.5-mm square lamellar sclerectomy was created at the external tip of the XEN gel stent implant. The lamellar scleral tissue, served as a patch graft, was secured at the gel stent insertion site. RESULTS: Four sequential, unselected, patients with failed primary XEN gel stent surgeries underwent bleb revisions with the technique described. These four patients achieved unmedicated intraocular pressures between 10 and 12 mmHg and a favourable bleb morphology despite repeated mitomycin C applications at 6 months. CONCLUSION: Lamellar sclerectomy with auto-scleral graft augmented XEN gel stent surgery deliver successful short-term outcomes without major complications observed.

A Retrospective Case Series of Uveal Effusion Syndrome.

PURPOSE: This study aimed to describe the clinical findings and management of eyes affected by uveal effusion syndrome. METHODS: We retrospectively evaluated the charts of 13 eyes of 8 consecutive patients diagnosed with uveal effusion syndrome attending the Ophthalmology Unit of the University Hospitals Leuven, Belgium, between 2007 and 2018. The presenting features, investigations, management, and outcomes were analyzed for each case. RESULTS: Cataract surgery was the predisposing factor for uveal effusion in 6 eyes, 2 bilateral uveal effusions (4 eyes) were considered to be medication-induced, and in 3 eyes, the uveal effusion was described as idiopathic. Fundus examination of 5 of 13 eyes showed bullous choroidal detachment, treated with pars plana vitrectomy with superotemporal sclerectomy or transscleral punction. Fundoscopy showed uveal effusion without serous retinal detachment in 3 eyes. Serous retinal detachment accompanied by uveal swelling was observed in 3 eyes and the 2 remaining eyes presented with uveal swelling only. The 8 nonbullous choroidal detachments were treated in a conservative way. A rapid resolution of subretinal fluid and uveal effusion was observed in all cases. CONCLUSIONS: A conservative approach with acetazolamide treatment or just observation was used in our case series in choroidal detachment without substantial visual loss if, over time, slow improvement was documented. However, further studies are needed to verify the effectiveness of the reported therapy.

iStent Inject (Second-generation Trabecular Microbypass) Versus Nonpenetrating Deep Sclerectomy in Association With Phacoemulsification for the Surgical Treatment of Open-angle Glaucoma and Cataracts: 1-Year Results.

PRECIS: Both nonpenetrating deep sclerectomy (NPDS) and iStent inject are safe and effective when combined with phacoemulsification. The NPDS group presented lower final intraocular pressure (IOP); however, more postoperative intervention and longer recovery time was required. AIM: The aim of this study was to assess the 1-year efficacy and safety of second-generation trabecular microbypass stent implantation (iStent inject) versus NPDS in association with phacoemulsification (Phaco) for the concomitant surgical treatment of open-angle glaucoma and cataracts. MATERIALS AND METHODS: This was a single-center longitudinal retrospective comparative study of eyes treated with Phaco-NPDS, with adjunctive use of collagen matrix implant and mitomycin C (group 1), or Phaco-iStent inject (group 2). The main outcome measures were success rates [absolute success: proportion of eyes with IOP<18 mm Hg without any glaucoma medication; relative success: proportion of eyes achieving different target IOPs (<18; <15; and <12 mm Hg) with or without medication]; mean reduction (%) in IOP and medication use; number of postoperative reinterventions (goniopuncture, needling, and reoperation); and number of complications. RESULTS: The mean age (y) was 69.3 in group 1 and 72.7 in group 2. Groups 1 (n=51) and 2 (n=32) achieved absolute success rates of 74.5% and 81.3%, respectively (P=0.333). Concerning relative success rates, no significant difference was found for IOP<18 mm Hg or an IOP<15 mm Hg between the 2 groups. However, significantly more eyes achieved an IOP <12 mm Hg in the Phaco-NPDS group. The mean percentage of IOP reduction from baseline to the end of follow-up was also statistically higher in group 1 (39.9% vs. 24.5%). Both groups achieved similar results in the mean reduction of medications per eye. No significant complications were found in either group, but patients in group 1 required more postoperative intervention than group 2. CONCLUSIONS: Both techniques are safe and effective for the concomitant surgical treatment of open-angle glaucoma and cataracts and presented comparable relative success rates at different target IOP levels (<18 and <15 mm Hg). A larger proportion of patients in group 1 achieved a target IOP <12 mm Hg; however, more postoperative intervention was required.

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.

Comparison of early versus late laser goniopuncture following deep sclerectomy for the management of open-angle glaucoma.

PURPOSE: To compare the outcome of early versus late Nd:YAG laser goniopuncture (LGP) after deep sclerectomy with mitomycin C (DSMMC) for open-angle glaucoma (OAG). METHODS: A retrospective study of consecutive OAG eyes that underwent a LGP following DSMMC was recruited between June 2012 and November 2015. Success was defined as intraocular pressure (IOP) less than 21, 18 or 15 mm Hg with a reduction of more than 20% IOP from baseline without (complete success) or with medications (qualified success). RESULTS: 99 eyes with OAG that underwent DSMMC were recruited into the study. Of these, 49 eyes (49.49%) had undergone LGP post-DSMMC. IOP was significantly reduced following LGP from 28.4 to 11.8 mm Hg. Comparison of Kaplan-Meier survival curves out to 60 months after LGP showed a trend towards better outcomes in the late LGP group with the only statistically significant difference noted for qualified success with IOP target <15 mm Hg. Complications were few with no difference noted between early and late LGP groups. CONCLUSION: There appears to be a trend towards late LGP being more effective after DSMMC when compared with early LGP; this however was not significant. This study corroborates previous published data confirming LGP is an effective and safe procedure for lowering IOP post-DSMMC procedure.

Modified CO2 Laser-assisted Sclerectomy Surgery in Chinese Patients With Primary Open-Angle Glaucoma and Pseudoexfoliative Glaucoma: A 2-Year Follow-up Study.

PRECIS: A modified CO2 laser-assisted sclerectomy surgery (CLASS) based on the characteristics of Chinese eyeball was carried out in Chinese patient and was confirmed to be effective and safe during long-term follow-up. PURPOSE: The purpose of this study was to study the long-term efficacy and safety of modified CLASS in Chinese patients with primary open-angle and pseudoexfoliative glaucoma. METHODS: We enrolled 25 medically uncontrolled primary open-angle and pseudoexfoliative glaucoma patients in this prospective, interventional case series. A combination of modified CLASS and preoperative laser iris management was administered to 29 eyes. Visual acuity, intraocular pressure (IOP), slit-lamp examinations, visual field, and gonioscopy were carried out at baseline and until 24 months postoperatively. Ultrasound biomicroscopy examinations were repeated at 3, 12, and 24 months postsurgically. RESULTS: Mean patient age was 53.92±12.08 years. Mean preoperative IOP was 30.66±10.41 mm Hg; and mean postoperative IOP was 8.17±3.76, and 13.25±2.73, 13.76±2.50, and 13.76±2.50 mm Hg at 1 day, and 6, 12, and 24 months, respectively. Proportional changes in IOP from baseline at 6, 12, and 24 months was 58.33%, 56.25%, and 58.97% (P<0.001), respectively. Complete postoperative success rates at 12 and 24 months were 62.07% and 48.28%. Qualified success rates at 12 and 24 months postoperatively were both 89.66%. Number of medications administered per patient reduced from 3 at baseline to 0 at 12 and 24 months (P<0.0001). Two patients demonstrated severe peripheral anterior synechiae (6.90%). Ultrasound biomicroscopy examination revealed a severe scleral lake diminution in 1 patient (3.40%) at 12 months and 2 patients (6.90%) at 24 months. CONCLUSION: Combination of modified CLASS and preventive laser iris management was effective and safe in the long-term treatment of primary open-angle glaucoma patients.

Prospective evaluation of penetrating deep sclerectomy in advanced open-angle glaucoma: Filtration surgery adapted to resource scarcity in developing countries.

PURPOSE: Two of the hurdles that are facing ophthalmologists in developing countries are scarcity of resources and patient follow-up. Deep sclerectomy (DS) has proven less costly and more effective than topical therapies and has a more favorable safety profile than trabeculectomy. The main factors preventing its use in developing countries are the need to perform laser goniopuncture in 40-80% of cases to maintain filtration and the risk of postoperative iris incarceration. The purpose of this study is to assess the efficacy and safety profile in advanced open-angle glaucoma of a relatively new surgical technique designed to overcome this limitation: penetrating DS. SETTING: This was an investigator-initiated, prospective, interventional study, conducted at a single ophthalmology center in Kinshasa, Congo. The study was conducted in full compliance with the Declaration of Helsinki. METHODS: Fifty-one eyes (34 patients) with uncontrolled advanced primary open-angle glaucoma (visual field mean deviation<-10 dBs) were enrolled between October 2012 and June 2016. Age, gender, comorbidities (hypertension/diabetes), best-corrected visual acuity, topical medications, medicated and unmedicated intraocular pressure (IOP) were recorded. All patients underwent penetrating DS, during which, following standard dissection of the scleral flaps, the anterior chamber was penetrated through the trabeculo-Descemet membrane and an iridectomy was performed. Patients attended postoperative appointments at months 1, 3, 6 and 12. Surgical success was defined as a 20% reduction of IOP from baseline in conjunction with a 12-month unmedicated IOP≤12mmHg. RESULTS: The mean age was 64.5±14.0 years (44.1% female, 100% African). Mean IOP decreased from 20.2±6.1 (medicated) and 30.7±9.8mmHg (unmedicated) preoperatively to 12.1±4.1 at 12 months. Concomitantly, the number of topical medications decreased from 1.5±0.7 to 0.0. Complete surgical success was achieved in 64.7%. Four eyes (7.8%) were considered surgical failures due to uncontrolled IOP. None of the eyes lost light perception or required additional surgery. A significant association between surgical failure and hypertension was observed (HR=1.49; P=0.008). There were no intraoperative complications. Postoperatively, 4 bleb encapsulations (7.8%) and 1 iris incarceration (2%) were observed. CONCLUSIONS: The present study demonstrates that penetrating DS achieved similar efficacy and safety results to traditional non-penetrating DS. In addition, it showed a lower potential for intraoperative complications, which might be associated with a more benign surgical learning curve. Finally, the rates of serious postoperative complications (iris incarceration, choroidal effusion and hypotony) were significantly lower than in DS and trabeculectomy, and this technique does not require subsequent Nd: YAG laser goniopuncture to maintain filtration, making frequent follow-up visits less critical. In view of these findings, perforating deep sclerectomy could offer a viable option for glaucoma management in developing countries as well as worldwide.

Penetrating deep sclerectomy in primary open-angle and pseudoexfoliative glaucoma.

PURPOSE: To evaluate the outcomes of a new antiglaucoma surgical method, a modification of the standard deep sclerectomy, the penetrating deep sclerectomy. PARTICIPANTS: Patients with medically uncontrolled primary open-angle glaucoma or pseudoexfoliative glaucoma were prospectively, in a consecutive way, enrolled in this study. METHODS: The study was conducted in Glaucoma Unit, Department of Ophthalmology, University of Hospital of Alexandroupolis, Greece, in 29 eyes of 29 patients. In a fornix-based surgical procedure, all eyes underwent the proposed penetrating deep sclerectomy (deep sclerectomy plus trabeculectomy) with the use of mitomycin C applied intraoperatively (0.2 mg/mL for 2 min). The follow-up period was 3 years. Ocular examination was conducted before the operation and at 1, 3, 6, 12, 18, 24, and 36 months postoperatively. RESULTS: The average reduction in intraocular pressure at the end of follow-up was 11.24 (57.88%). The complete success rate (intraocular pressure ⩽21 mm Hg without medication) after 3 years was 58.6%. The qualified success rate (intraocular pressure ⩽21 mm Hg without or with medication) was 75.86%. Postoperatively, the mean number of medication dropped from 3.75 ± 0.89 to 0.89 ± 0.98. Low postoperative complications were recorded. CONCLUSION: During the 3-year follow-up period, penetrating deep sclerectomy presented very positive outcome. The addition of a controlled perforation of the trabeculo-Descemet's membrane in deep sclerectomy, playing the role of an early goniopuncture, seems to ensure a satisfactory outcome and is not associated with additional complications.