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.

Risk Factors for Failure in Glaucoma Patients Undergoing Microshunt Implantation.

PURPOSE: To evaluate risk factors for failure of Microshunt in glaucoma patients. DESIGN: Multicenter retrospective cohort study. METHODS: The study included 220 eyes from 220 consecutive glaucoma patients undergoing Microshunt implantation at six glaucoma units. Four intraocular pressure (IOP) success criteria were defined: (A) IOP ≤21 mm Hg with ≥20% IOP reduction; (B) IOP ≤18 mm Hg with ≥20% IOP reduction; (C) IOP ≤15 mm Hg with ≥25% IOP reduction; and (D) IOP ≤12 mm Hg with ≥30% IOP reduction from baseline. Kaplan-Meier analysis was used to estimate success rates according to the criteria above, and multivariable Cox models were used to identified risk factors for failure according to criterion A. RESULTS: Success rates varied based on different criteria, ranging from 43.3% to 62.5% (overall success for criteria D and A, respectively) and from 35.3% to 44.4% (complete success for criteria D and A, respectively) at 1-year follow-up. Higher intraoperative MMC concentration was associated with reduced risk of failure to maintain complete (0.4 vs 0.2 mg/mL: hazard ratio [HR] = 0.441, P < .001) and overall (0.4 vs 0.2 mg/mL: HR = 0.360, P = .004) success. For complete success, other risk factors for failure were pseudoexfoliation glaucoma/pigmentary glaucoma (HR = 1.641, P = .004), primary angle closure glaucoma (HR = 1.611, P < .001), and previous non-glaucomatous ocular surgeries (HR = 2.301, P = .002). For overall success, other risk factors for failure were lower preoperative IOP (for 1-mm Hg increase, HR = 0.934, P = .005), higher number of preoperative antiglaucoma agents (HR = 1.626, P < .001), and Microshunt combined with cataract surgery (HR = 1.526, P = .033). CONCLUSIONS: This study identified risk factors for Microshunt failure, highlighting the importance of high intraoperative MMC dose and careful patient selection to optimize surgical success.

Epidemiology of Corneal Neovascularization and Its Impact on Visual Acuity and Sensitivity: A 14-Year Retrospective Study.

Purpose: To quantify the severity and location of corneal neovascularization (cNV) and its impact on the visual acuity and corneal sensitivity in a cohort of the patients referred to a specialist cornea clinic and also to describe the etiology of cNV in the cohort. Methods: We retrospectively evaluated the charts of 13,493 subjects referred to the San Raffaele Cornea Unit between January 2004 and December 2018 to search for cNV diagnosis. The corneal neovascularization severity was measured in the quadrants (range: 1-4) and location was defined as superficial, deep, or both. Best spectacle corrected visual acuity (BSCVA) was measured in logMar. We used the multiple regression analysis to identify the independent predictors of logMAR, after adjusting for age, gender, keratoconus, herpes keratitis, penetrating keratoplasty, trauma, and cataract surgery. Results: Corneal neovascularization was diagnosed in 10.4% of the patients analyzed. The most prevalent etiology of cNV in our population was non-infectious corneal dystrophies/degenerations followed by herpes simplex virus infection. cNV affected OD, OS, or both eyes in 35.6, 40.2, and 24.2 of cases, respectively. Mean BSCVA (SD) was 0.59 (0.76), 0.74 (0.94), and 1.24 (1.08) in cNV one, two, and three or four of the quadrant groups. Superficial, deep, or mixed cNV occurred in 1,029, 348, and 205 eyes. Severe cNV (three or four of the quadrants) was a significant predictor of low visual acuity (p < 0.001) and reduced corneal sensitivity (p < 0.05). cNV location and its severity were associated (p < 0.05). In addition, corneal anesthesia was associated with lower BSCVA (p < 0.001). Conclusion: Severe and deep cNV are associated with the reduced visual acuity and corneal sensitivity. Our data strongly support the relevance of appropriate follow-up as cNV is a major risk factor for graft rejection.

Treatment Outcomes Using the PAUL Glaucoma Implant to Control Intraocular Pressure in Eyes with Refractory Glaucoma.

PURPOSE: To investigate efficacy 1 year after implantation of a novel glaucoma tube shunt, the PAUL Glaucoma Implant (PGI; Advanced Ophthalmic Innovations, Singapore, Republic of Singapore), in the treatment of eyes with refractory glaucoma. DESIGN: Clinical trial. PARTICIPANTS: Glaucoma patients who are recalcitrant to maximum tolerated medical therapy and require tube shunt surgery. METHODS: Interventional cohort study involving consecutive PGIs implanted at 6 international centers between December 1, 2017, and December 1, 2018. All the participants were followed up for 1 year after surgery. MAIN OUTCOME MEASURES: The primary outcome measure was failure, defined prospectively as intraocular pressure (IOP) of more than 21 mmHg or less than 20% reduction from the preoperative baseline on 2 consecutive visits, 3 months or more after surgery; persistent late hypotony, defined as IOP of less than 6 mmHg on 2 consecutive visits after 3 months; additional glaucoma surgery; loss of light perception vision; or removal of the implant for any reason. RESULTS: Of 82 patients enrolled, 74 (74 eyes) completed 12 months of follow-up. The mean age ± standard deviation at enrollment was 62.3±14.7 years, 73.0% were men, and 36.5% had secondary glaucoma. One year after surgery, 4 patients (5.4%) fulfilled the surgical criteria for failure, 68.9% (51/74 eyes) were deemed complete successes, and 93.2% (69/74 eyes) were considered qualified successes. Compared with the medicated preoperative IOP (23.1±8.2 mmHg), the postoperative IOPs at 6 and 12 months were 13.8±4.0 mmHg and 13.2±3.3 mmHg, respectively (P < 0.001). The mean number of IOP-lowering drugs used before surgery and after 12 months of follow-up were 3.3±0.9 and 0.3±0.6, respectively (P < 0.001). Significant postoperative complications included self-limiting shallow anterior chamber (n = 11; 14.9%), hypotony requiring intervention (n = 7; 9.5%), tube shunt occlusion (n = 5; 6.8%), tube exposure (n = 3; 4.1%), and endophthalmitis with resultant loss of vision (n = 1; 1.4%). CONCLUSIONS: The PGI demonstrated comparable efficacy with other currently available implants, with almost three quarters of the enrolled patients with refractory glaucoma achieving complete surgical success after 1 year of follow-up.

Correlation of SD-OCT findings and visual function in patients with retinitis pigmentosa.

PURPOSE: To describe the morphological macular changes detected by spectral domain optical coherence tomography (SD-OCT) in eyes with retinitis pigmentosa (RP) and to analyze their correlation with the visual function. METHODS: Twenty-two patients (44 eyes) patients affected by RP were recruited. The following structures were evaluated on SD-OCT: outer plexiform layer (OPL), outer nuclear layer (ONL), external limiting membrane (ELM), photoreceptor inner/outer segment (IS/OS) junction, photoreceptor outer segment/retinal pigmented epithelium (OS/RPE) junction, inner limiting membrane thickening (ILMT), ganglion cell complex (GCC), and cystoid macular edema (CME). The relation between each SD-OCT finding and BCVA was evaluated at uni- and multivariate analysis. RESULTS: Mean age and mean best-corrected visual acuity (BCVA) were 51 ± 17.5 years and 0.4 ± 0.5 LogMAR, respectively. Univariate linear regression model revealed a correlation between BCVA and the absence of ELM, IS/OS, ONL, and OS/RPE layers (R (2) values were, respectively, 0.51, 0.57, 0.48, and 0.68, with p values all <0.0001). At multivariate regression analysis, the absence of OS/RPE and ELM layers remained the only variables independently associated with a decrease of BCVA (R (2) = 0.85, t = 3.49, p = 0.0014). CONCLUSIONS: Data show that in patients afflicted with RP, ELM and OS/RPE layers are independently associated with BCVA on multivariate regression analysis. These results highlight the key-role of external retinal layers in determining the visual function impairment attributable to RP.

Stereotactic radiotherapy for polypoidal choroidal vasculopathy: a pilot study.

PURPOSE: To evaluate low-voltage X-ray stereotactic radiotherapy (SRT) delivered in conjunction with intravitreal ranibizumab for the treatment of active macular polypoidal choroidal vasculopathy (PCV). METHODS: At baseline, all eyes received an intravitreal injection of ranibizumab, followed by 16-Gy X-ray SRT to the macula. Further ranibizumab injections were given pro re nata. The primary outcome measure was regression of the polyps assessed by indocyanine green angiography. Secondary outcome measures were best-corrected visual acuity (BCVA) and central foveal thickness (CFT) changes on optical coherence tomography. Local or systemic adverse events were evaluated as well. RESULTS: We examined 12 eyes of 12 patients with PCV. At month 12, an angiographic regression of the polyps was observed in 10 of the 12 eyes. The mean BCVA improved by 7.6 letters: from 65.08 ± 11.4 to 72.7 ± 14.75 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The mean CFT decreased from 372.3 ± 79.6 to 215.9 ± 57.9 µm (p < 0.01). No local or systemic adverse events were reported. CONCLUSIONS: The preliminary data support the safety of low-voltage X-ray SRT for the treatment of macular PCV and show polyp closure, reduction in CFT and improvement in the mean BCVA. Additional research is warranted to confirm the efficacy and longer-term safety of this therapy in this population.

Changes in macular function after ozurdex for retinal vein occlusion.

PURPOSE: To investigate changes in macular function after intravitreal dexamethasone implant (Ozurdex) for macular edema (ME) secondary to retinal vein occlusion (RVO). METHODS: Nineteen treatment-naive patients with RVO-related ME were treated with intravitreal Ozurdex and followed up to 6 months to evaluate functional outcomes, by means of best-corrected visual acuity, microperimetry, and multifocal electroretinography, and their correlations with morphological parameters by enhanced depth imaging optical coherence tomography. RESULTS: Nineteen eyes of 19 patients were included for analysis. At 1 month, mean best-corrected visual acuity, retinal sensitivity, and central macular thickness (CMT) improved from 0.50 ± 0.34 LogMAR, 10.51 ± 4.31 dB, and 762 ± 259 µm (baseline) to 0.38 ± 0.34 LogMAR (p = 0.043), 12.28 ± 5.06 dB (p = 0.025), and 385 ± 191 µm (p = 0.001), respectively. At 3 months, improvement of mean retinal sensitivity and CMT was still significant (11.62 ± 5.05 dB [p = 0.047] and 518 ± 251 µm [p = 0.006]). Multifocal electroretinography measurements also showed (nonsignificant) improvement. No significant changes in choroidal thickness were recorded. Improvements recorded during the first 3 months were no longer significant from month 4. At each time point, we found a negative significant correlation between CMT and retinal sensitivity. Interestingly, 7 eyes did not undergo retreatment of less than 6 months; these eyes showed a significantly better baseline retinal sensitivity than eyes requiring retreatment of less than 6 months (12.27 ± 3.52 dB vs. 9.48 ± 4.53 dB [p = 0.038]). CONCLUSIONS: In eyes with ME secondary to RVO, intravitreal dexamethasone implant provides functional benefits as soon as 1 month after treatment. In most cases, the optimum retreatment interval is less than 6 months from first intravitreal Ozurdex. Microperimetry is a very useful tool to characterize macular function. Baseline macular sensitivity may predict the need for early (<6 months) retreatment.

Impact of intravitreal dexamethasone implant (Ozurdex) on macular morphology and function.

PURPOSE: To investigate the impact of intravitreal dexamethasone implant (Ozurdex) on macular morphology and function in eyes with macular edema secondary to central retinal vein occlusion. METHODS: Twelve treatment-naive patients with decreased visual acuity because of central retinal vein occlusion-related macular edema were enrolled in this prospective uncontrolled study. Patients were treated with intravitreal Ozurdex and followed up at 1 month and 3 months for the evaluation of morphologic and functional outcomes, by means of best-corrected visual acuity, microperimetry, multifocal electroretinography, and customized high-resolution enhanced depth imaging spectral-domain optical coherence tomography scans. RESULTS: Twelve eyes of 12 patients (10 men, 2 women; mean age 56.2 ± 13.0 years) were included for analysis. At 1 month, mean best-corrected visual acuity, retinal sensitivity (microperimetry), multifocal electroretinography parameters, central macular thickness, and specific neurosensorial retinal measurements improved significantly. We found a significant negative correlation between retinal sensitivity and central macular thickness at 1 month and 3 months (r = -0.831, P = 0.001; r = -0.881, P = 0.001; respectively). Moreover, retinal sensitivity was negatively related to both outer and inner retinal thickness in all four intervals from the fovea. From baseline to Month 1, change in outer retinal thickness was positively related to multifocal electroretinography N1R1 amplitude change (r = 0.698, P = 0.012), whereas change in central macular thickness was negatively related to multifocal electroretinography P1R1 amplitude change (r = -0.701, P = 0.011). At 3 months, improvement of mean retinal sensitivity and central macular thickness slightly decreased. CONCLUSION: In eyes with macular edema secondary to central retinal vein occlusion, intravitreal dexamethasone provides functional benefits that correlate well with ultrastructural macular changes.

Natural course of photic maculopathy secondary to uncomplicated cataract surgery.

We report on a 36-year-old man who developed photic maculopathy in the left eye shortly after uncomplicated cataract surgery. The visual acuity (VA) of the left eye was 6/39 and spectral domain optical coherence tomography (SD-OCT), performed one week after surgery, revealed a hyporeflective space in the outer retina (a 'partial-thickness hole') at the fovea. Microperimetry showed a relative central scotoma and multifocal electroretinogram (ERG) showed reduced responses within the central 10°. Two months later, VA in the felt eye improved to 6/6 and SD-OCT showed an almost complete resolution of the 'partial-thickness hole'. Microperimetry showed the resolution of the relative scotoma at the fovea and multifocal ERG showed improved responses within the central 10°. SD-OCT, microperimetry and multifocal ERG are useful tools in the diagnosis and follow-up of photic maculopathy after uncomplicated cataract surgery. Its natural history may be characterised by resolution of both morphological and functional changes shortly after surgery.

In vivo confocal microscopy in goldenhar syndrome: a case report.

BACKGROUND: Goldenhar Syndrome is characterized by malformations of multiple anatomical districts. Between these, bulbar dermoids are common and represent a significant clinical problem as they can affect both ocular function and aesthetic comfort.Histologic characterization of dermoids has been extensively performed; however, no reports exist describing in vivo confocal microscopy (IVCM) of these lesions. We aimed to (i) describe the in vivo confocal morphology of limbal dermoids in Goldenhar syndrome and (ii) compare these findings with standard light microscopy. CASE PRESENTATION: A 15-year-old Caucasian female affected by Goldenhar Syndrome showed a left, infero-temporal, limbal neoformation, with extension to the left orbital region. Prior to surgical removal, IVCM was performed with the Heidelberg Retina Tomograph II, Cornea Module, using the "section" modality. The IVCM sections showed structures resembling corneal epithelium and vascular structures. Surgical removal of the lesion was decided as it caused poor eyelid closure. After surgical removal, sectioning and standard optical microscopy were performed. The comparison between IVCM imaging and standard microscopy sections were highly correlated in the detection of the pilar and vascular structures. CONCLUSIONS: This study showed that IVCM may be a useful technique to study limbal dermoids, given its ability to detect typical microscopic features and its comparability to optical microscopy, which is the current standard.

Spectral domain optical coherence tomography findings in patients with retinitis pigmentosa.

BACKGROUND: To report the morphological macular findings detected by spectral domain optical coherence tomography (SD-OCT) and to determine their prevalence in patients with retinitis pigmentosa (RP). METHODS: SD-OCT scans of 176 eyes from 90 patients affected by RP were reviewed. A careful evaluation was carried out on photoreceptor inner/outer segment (IS/OS) junction, external limiting membrane (ELM), inner limiting membrane thickening (ILMT), epiretinal membranes (ERMs), retinal micropseudocysts (MPCs), cystoid macular edema (CME), macular holes (MHs) and choroidal neovascularization (CNV). RESULTS: The photoreceptor IS/OS junction was absent in the foveal region of 24 eyes (13.6%) and disrupted in 84 eyes (47.7%). The ELM was absent in 24 eyes (13.6%), whereas the ILMT was found in 118 eyes (67%). The presence of an ERM was detected in 48 eyes (27.3%). Some sort of vitreomacular alteration (ILMT and/or ERM) was identifiable in a total of 94.3% of eyes with RP. The presence of MPCs was detected in 32 eyes (18.2%). An evident CME was found in 22 eyes (12.5%). We also found MHs in 8 eyes (4.5%) and CNV in 3 eyes (1.7%). CONCLUSIONS: Our data indicate that RP is associated with alterations of many retinal layers. In particular, the vitreoretinal interface is affected in 94% of patients, and MPC can be identified in 18% of eyes. SD-OCT may contribute to the understanding of the pathophysiological mechanism involved in RP.