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.

Outcomes of combined phacoemulsification, anterior vitrectomy, and sclerectomy in nanophthalmic eyes with glaucoma.

OBJECTIVES: To compare the long-term efficacy and safety of combined phacoemulsification, anterior vitrectomy, and sclerectomy (triple procedure surgery, TS); combined phacoemulsification and anterior vitrectomy (double procedure surgery, DS); and filtering surgery (FS) in nanophthalmos with angle-closure glaucoma (NACG). METHODS: Retrospective cohort study. Forty patients (44 eyes) diagnosed with NACG who underwent TS, DS, and FS were included. All eyes in the TS group and seven (47%) eyes in the DS group also underwent goniosynechialysis during the surgery. The main outcome measures (intraocular pressure [IOP], best-corrected visual acuity, complications, and second surgeries) were recorded at the early- (within 1 week) and late-stage (>3 months) follow-up. RESULTS: The late-stage IOP was significantly lower in the TS (mean ± standard deviation: 13.29 ± 2.49 mm Hg) than in the DS (19.69 ± 6.97 mm Hg) and FS groups (27.57 ± 12.26 mm Hg, p < 0.001). More visual improvements were observed in the TS and DS groups than in the FS group at late-stage follow-up (p = 0.04). The complication rates in the TS, DS, and FS groups were 26%, 33%, and 70%, respectively (p = 0.046); the second surgery rates were 0%, 33%, and 60%, respectively (p < 0.001). In total, one, three, and six severe complications were observed in the TS, DS, and FS groups, respectively. The mean follow-up durations in the TS, DS, and FS groups were 18.89, 20.02, and 25.75 months, respectively. CONCLUSIONS: NACG management remains challenging. TS presented relatively good clinical efficacy and safety with better postoperative IOP outcomes, lower complications, and second surgery rates among the three groups in eyes with NACG.

Laser goniopuncture after deep sclerectomy: incidence, long-term outcomes and risk factors for failure.

AIMS: To report the incidence, risk factors and long-term outcomes of laser goniopuncture (LGP) in patients with previous deep sclerectomy (DS). METHODS: Retrospective cohort study of 1765 eyes (1385 patients) undergoing DS with or without cataract surgery between 2001 and 2020 in two UK institutions. Kaplan-Meier was used to estimate LGP incidence. DS success after LGP was calculated for criteria A, B, and C defined as intraocular pressure (IOP) of ≤18, ≤15 and ≤12 mm Hg with 20%, 25% and 30% reduction, respectively. Cox regression was used to investigate factors associated with the risk of failure. RESULTS: LGP had an estimated incidence of 33.3% (30.9%-35.6%), 56.3% (53.5%-58.9%) and 62.8% (59.7%-65.6%) at 1, 3, 5 years, respectively. Mean (±SD) IOP significantly (p<0.001) decreased from 21.2 (±6.0) mm Hg pre-LGP to 13.8 (±5.2) mm Hg and 12.9 (±4.7) mm Hg at 3 and 5 years post-LGP, respectively. Success rates at 3 and 5 years were, respectively, 40.9% (37.5%-44.6%) and 33.7% (30.3%-37.6%) for criterion A; 27.1% (24.0%-30.5%) and 22.3% (19.3%-25.7%) for criterion B and 13.9% (11.6%-16.7%) and 11.6% (9.5%-14.3%) for criterion C. In all models, higher pre-LGP IOP (p<0.001) and higher pre-LGP medication number (p<0.001) were associated with increased failure, while male gender (p≤0.004), intraoperative mitomycin C (p≤0.031), longer interval between DS and LGP (p≤0.01) with reduced failure. CONCLUSION: Most patients undergoing DS will eventually require LGP. LGP is effective at rescuing eyes with a failing DS. This study identifies several factors associated with LGP outcomes, knowledge of which may help clinicians predict LGP success.

Non-penetrating deep sclerectomy with the sub flap (Ahmed's) suture: a 12-month comparative study.

PURPOSE: To assess the IOP-lowering effect of adding a mattress suture (Ahmed's suture) to non-penetrating deep sclerectomy (NPDS), in patients with open angle glaucoma over a 12-month follow-up period. METHODS: This is a randomized controlled study comparing 52 eyes with a sub-flap Ahmed's suture modified NPDS (group A) and 51 with a conventional NPDS (group B). Success of surgery was categorized as complete success if the IOP remained between 6 and 18 mmHg without medications and as qualified if topical medications were required. RESULTS: The post-operative IOP at the 1st week, 3rd, 6th, 9th & 12th months follow ups in group A were significantly lower (7.3 ± 2.1, 12.0 ± 2.3, 12.6 ± 2.7, 13.6 ± 3.4 & 13.8 ± 3.8 mmHg) than in B (9.2 ± 1.9, 14.0 ± 3.1, 14.8 ± 2.9, 15.4 ± 2.6 & 15.7 ± 2.7 mmHg) (p = 0.001, p = 0.001, p = 0.002, p = 0.027 & p = 0.029 respectively). The percentage of IOP reduction after 1 year was significantly higher in group A than in group B (49% vs. 36.5%). At the end of the 12-month follow-up, 81% of group A and 69% of group B were considered as complete success. Multivariate regression analysis showed lower 1st week post-operative IOP was associated with better outcome. CONCLUSION: In conclusion, the Ahmed's suture, a simple, novel and economic modification, maintains lower IOP levels and has a higher success rate over conventional DS, as it is 30% more effective in reducing the IOP.

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.

Novel Technique for 27-Gauge Forceps-Assisted Transscleral Refixation of the Dislocated CZ70BD Intraocular Lens.

PURPOSE: To report a novel technique for refixation of the dislocated CZ70BD intraocular lens. METHODS: Posterior vitrectomy is performed with a 23-gauge or 25-gauge pars plana vitrectomy system with chandelier illumination. One needle of a double-arm 9-0 prolene needle is passed through the sclera 1.5 mm postlimbus. The needle is retrieved through the corneal paracentesis using a 27-G needle, and the suture is then cut. The suture end is passed through the eyelet of the dislocated CZ70BD intraocular lens inside the vitreous cavity. This is aided with a pair of 27-G MaxGrip forceps, which is inserted through a 27-G sclerostomy site at the intended scleral outlet. After passing the suture through the eyelet, the suture is pulled out at the 27-G sclerostomy site and a knot is tied and rotated. Similar procedure is performed for the second haptic if necessary. RESULTS: Seven eyes were successfully operated on using this technique with a mean follow-up of 12.4 months. There was significant improvement in the best-corrected visual acuity after the operation ( P = 0.016). Postoperative intraocular lens centration and alignment were satisfactory. One patient developed macula-on retinal detachment 1 month after the operation, which was successfully repaired without loss in the best-corrected visual acuity. CONCLUSION: The described novel technique is effective for refixation of dislocated CZ70BD intraocular lens.

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.

Efficacy and Safety of Deep Sclerectomy With the Esnoper Clip Implant for Uncontrolled Primary Open Angle Glaucoma: A 1 Year Prospective Study.

PRCIS: Deep sclerectomy (DS) with the Esnoper Clip drainage implant in patients with uncontrolled primary open angle glaucoma (POAG) achieved a complete success rate of 87.2% at the 1-year follow-up. PURPOSE: To investigate the efficacy and safety of DS followed by Esnoper Clip implantation in patients with uncontrolled POAG. MATERIALS AND METHODS: In a prospective, consecutive, interventional study, we investigated 39 eyes of 35 patients with uncontrolled POAG who underwent DS with Esnoper Clip implantation. Complete ophthalmologic examinations including corrected visual acuity and intraocular pressure (IOP), were performed preoperatively, and at 1 day, at 1 week as well as at 1, 3, 6, 9, and 12 months postoperatively. Moreover, any goniopunctures and glaucoma medications required postoperatively were noted. RESULTS: The mean preoperative IOP was 20.8±5.2 mm Hg and it decreased to 13.9±3.1 mm Hg at 1 year postoperatively ( P <0.001). The number of glaucoma medications decreased from 2.9±0.7 preoperatively to 0.3±0.8 after 1 year ( P <0.001). The complete success rate (IOP≤21 mm Hg without glaucoma medication) and the qualified success rate (IOP ≤21 mm Hg with or without glaucoma medication) were 87.2% and 94.9%, respectively. Goniopuncture was performed in 33.3% of cases. No significant corrected visual acuity changes were registered at the final follow-up. Perioperative complications consisted of 3 micro-perforations of the trabeculo-descemet membrane. Postoperative complications included: hyphema (6 eyes), hypotony (6 eyes), shallow anterior chamber (3 eyes), choroidal detachment (4 eyes)-all of which were resolved without surgical intervention during the first postoperative month-and conjunctival dehiscence, which required resuture (2 eyes). CONCLUSION: Deep sclerectomy with the Esnoper Clip implant was safe and effectively lowered IOP in patients with uncontrolled POAG.

Same-site trabeculectomy with mitomycin and Ologen™ following failed non-penetrating deep sclerectomy.

PURPOSE: To assess the effectiveness and safety of same-site trabeculectomy (TRAB) with mitomycin C (MMC) and Ologen™ (Aeon Astron Europe BV. Leiden, The Netherlands) in patients with a failed non-penetrating deep sclerectomy (NPDS). METHODS: A retrospective study of 24 consecutive eyes (22 patients) undergoing reintervention by same-site TRAB with at least one-year follow-up after failed NPDS. Mean visual acuity (VA), intraocular pressure (IOP) and use of glaucoma medications were compared before and one year after surgery. Early and late postoperative complications were registered. Kaplan-Meier survival analysis was performed according to four levels of success criteria. RESULTS: Overall the mean IOP reduced significantly (24.9 ± 7.1 vs. 14.4 ± 4.5 mmHg; p < 0.001), and the number of glaucoma medications (2.80 ± 1.01 vs. 0.55 ± 0.94; p < 0.001) significantly decreased, one year after surgery. The mean VA remained stable one year after surgery (p = 0.516). Hypotony, defined as IOP ≤ 5 mmHg, in the early postoperative period was observed in 62.5% of eyes, but only in 2 patients (8.33%) in the long term. The mean survival time ranged from 10 months (CI 95% 5-15) to 29 months (CI 95%: 26-32) according to the most stringent and lenient success criteria respectively. CONCLUSION: Same-site TRAB augmented with MMC and Ologen™ may provide an effective, safe and lasting alternative following failed NPDS, especially when sparing of the conjunctiva is highly desirable. Postoperative hypotony is the most common postoperative complication.

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.

Sutureless versus conventional deep sclerectomy for management of open angle glaucoma.

INTRODUCTION: To compare sutureless deep sclerectomy to conventional deep sclerectomy regarding their lowering effect on intraocular pressure (IOP) in cases with open-angle glaucoma. METHODS: This is a prospective interventional randomized comparative study that included 60 eyes of 50 patients with open-angle glaucoma (OAG) who were indicated for surgical intervention. Patients were recruited from the glaucoma subspecialty clinic of the Cairo University teaching hospital and were divided into two groups: group A (underwent sutureless deep sclerectomy) and group B (underwent conventional deep sclerectomy). RESULTS: Both surgeries showed significant reduction of IOP all through the study period: in group A, mean reduction was 71.37%, 53.35%, 50.3%, and 44.33% at 1st day, 1 month, 3 months, and 6 months respectively, and in group B, mean reduction was 57.62%, 40.63%, 37.41%, and 31.68% at 1st day, 1 month, 3 months, and 6 months, respectively. Comparison between percentage of reduction in both groups showed no statistically significant difference. Also, use of anti-glaucoma medications dropped significantly at 6 months postoperatively in both groups with no significant difference between the 2 groups. Regarding reported complications, 12.9% in group A and 10.3% in group B presented with non-serious complications. One month postoperatively, UBM detected non-functioning blebs in 6.4% of group A and 3.4% in group B. Other cases with non-functioning blebs were detected at 3 and 6 months postoperatively, and all cases were managed. CONCLUSION: Sutureless deep sclerectomy seems to be a safe and effective modification, with significant IOP reduction in POAG.

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.

A modified model of glaucoma filtering surgery in Sprague-Dawley rats.

Animal models are useful in glaucoma research to study tissue response to wound healing. Smaller animals such as rats offer additional advantages in terms of availability of detection antibodies and microarrays with cheaper maintenance costs. In this study, we describe a glaucoma filtering surgery (GFS) model in adult Sprague-Dawley rats by performing a sclerostomy using a 26-G needle and additionally placing a silicone tube (27 G) connecting the anterior chamber to the subconjunctival space to maintain a patent fistula for the flow of aqueous humor, thus providing a more definitive bleb. This technique will be useful in identifying and modifying newer targets in the wound healing process in order to improve surgical outcomes following GFS.

Intermediate Outcomes of Deep Sclerectomy in Juvenile Glaucoma.

PRCIS: In this retrospective study of patients with predominantly severe juvenile open-angle glaucoma, deep sclerectomy (DS) achieved a success rate [defined as intraocular pressure (IOP) between 5 to 18 mm Hg] of 72% at 3 years. PURPOSE: The purpose of this study was to evaluate the safety and efficacy of DS in patients with juvenile open-angle glaucoma (JOAG). METHODS: A retrospective chart review of all JOAG patients that underwent DS with mitomycin C at a tertiary care eye center during the period from May 2014 to May 2019. RESULTS: A total of 50 eyes in 37 patients were included. The mean age at the time of surgery was 27.1±11.3 years and the majority of patients (86%) had a cup-disc ratio of 0.8 to 0.9. The mean duration of follow-up was 26.1±13.4 months (range 12 to 54 mo). Mean IOP was reduced from 26.1±13.4 mm Hg at baseline to 15.2±6.4 mm Hg at the last follow-up visit (P<0.01). Moreover, the mean number of glaucoma medications decreased from 3.8±0.5 at baseline to 0.8±1.2 at the last follow-up visit (P<0.01). The cumulative probabilities of overall success (defined as IOP between 5 and 18 mm Hg) at 12, 24, and 36 months were 94%, 85%, and 72%, respectively. Hypotony occurred in 4 eyes (8%), and in one of these patients, the final visual acuity was >2 lines worse compared with presentation. No other vision-threatening complications were encountered. CONCLUSION: DS in JOAG was safe and successfully controlled IOP in most patients for 3 years.

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.