Evaluation of the Use of Highly Concentrated Autologous Platelet-Rich Plasma and Platelet-Rich Fibrin Membrane to Improve the Outcome in the Management of Severe Dry Eye Disease, Corneal Neurotrophic Ulcer and Corneal Burn.

INTRODUCTION: The aim of this study was to evaluate the use of highly concentrated platelet-rich plasma (PRP) subconjunctival injections, in combination with eye drops (eye PRP, or E-PRP), in treating dry eye disease (DED) and the use of platelet-rich fibrin (PRF) membrane in treating corneal burns and neurotrophic ulcers for the restoration of the homeostasis of the tear film and the morphology and function of the cornea. METHODS: We studied 16 patients (n=32 eyes) with severe DED. The disease was graded as severe according to the Oxford Grading Scale. There were 12 males (75%) and four females (25%) with a mean age of 56 years; these patients were treated with monotherapy, which involved a single subconjunctival injection of 0.2-0.3 mL of PRP prepared from autologous blood, followed by application of autologous PRP eye drops four times a day for 15 days between September 2019 and December 2020 in the same geographic area. All patients gave written informed consent before undergoing the outlined treatment protocol. We evaluated best corrected visual acuity (BCVA), Schirmer test score, tear film breakup time (TBUT) and corneal staining with fluorescein (Oxford Grading Scale) before and after six to eight weeks of treatment. Subjective normalization was defined by a decrease in the Ocular Surface Disease Index (OSDI) score to 10 or less, an objective normalization of the TBUT to five to six seconds, improvement in the Schirmer test score and Oxford grading and the BCVA gain of at least one line in the vision chart (Snellen chart). Furthermore, we report on the results from different variants of platelet concentrate-based treatments in five cases of corneal diseases: neurotrophic ulcers and corneal burns due to different causes (e.g., chemical burns) using E-PRP and PRF membrane with regard to normalization of morphology and function. RESULTS: The OSDI score decreased to normalization in 75% of the patients (p=6.545 × 10-15). TBUT was restored significantly in 20 of 32 eyes from 2.78±0.55 to 5.43±0.71 (p=1.612 × 10-24). The Schirmer test score showed an improvement from 4.46±0.67 to 10.28±1.18 (p=3.411 × 10-29), and BCVA improved by 43.75%, from 0.15±0.19 to 0.09±0.16 (logMAR, p=0.2331). Oxford grading changed to Scale I in 75% and Scale 0 in 25% of the patients. No complications or adverse reactions occurred in the five cases of corneal injuries. We observed a restoration of the morphology and function of the cornea with PRP injections or PRF+PRP application in 7-12 days, depending on the severity of the initial finding. CONCLUSION:  PRP treatment is a new approach in ophthalmology with impressive results. Although patients show good compliance and acceptance of the treatment protocol, studies with larger sample sizes are needed to confirm and optimize its use.

Long-term effect of canaloplasty on intraocular pressure and use of intraocular pressure-lowering medications in patients with open-angle glaucoma.

PURPOSE: To assess the long-term safety and effectiveness of canaloplasty in reducing intraocular pressure (IOP) and use of IOP-lowering medications in eyes with open-angle glaucoma (OAG). SETTING: Surgical center (Augencentrum Köln, Köln, Germany). DESIGN: Retrospective study. METHODS: 206 eyes from 130 patients were included. Canaloplasty was performed using the VISCO360 or OMNI surgical system as a stand-alone procedure in 22 eyes and concomitantly with cataract extraction (CE) in 185 eyes with chronic OAG insufficiently controlled or intolerant to IOP-lowering medications. The number of hypotensive medications and IOP were recorded at baseline, day 1, week 1, month 1, month 3, and every 3 months thereafter, with the last follow-up visit at 36 ± 6 months postoperatively. Patients were stratified by baseline IOP (Group 1, IOP >18 mm Hg; Group 2, IOP ≤18 mm Hg). Treatment success in Group 1 was defined as a reduction in IOP and the use of IOP-lowering medications; Group 2 success was defined as maintenance of a lower IOP and a reduction in medication use. RESULTS: The preoperative mean IOP of both groups was 21.1 ± 8.8 mm Hg, with a mean of 2.0 ± 0.9 hypotensive medications. The primary success end point was met by 73% of patients, with a mean IOP reduction in Group 1 (131 eyes; 21.8 to 15.6 mm Hg, P < .0001) and a maintenance of IOP control in Group 2 (76 eyes; 15.4 to 13.9 mm Hg, P = .24). Medications decreased from 2.2 ± 0.9 to 0.9 ± 1.1 in Group 1 ( P = .024) and from 1.8 ± 0.8 to 0.7 ± 1.0 in Group 2 ( P = .003). CONCLUSIONS: Canaloplasty alone or in conjunction with CE with the VISCO360 or OMNI surgical system is a safe, tissue-sparing, and effective minimally invasive glaucoma surgery, using a clear corneal incision in phakic or pseudophakic eyes. Canaloplasty performed with both evaluated devices achieved statistically significant, consistent, and clinically meaningful reductions in IOP and use of IOP-lowering medications in adult patients with OAG. In the consistent cohort (n = 42), the IOP-lowering effect lasted up to 42 months, with ongoing data collection expected to describe long-term effectiveness of this intervention.

360° ab-interno Schlemm's canal viscodilation in primary open-angle glaucoma.

Purpose: To evaluate the safety and effectiveness of ab-interno microcatheterization and 360° viscodilation of Schlemm's canal (SC) using the VISCO360® Viscosurgical System in treatment of primary open angle glaucoma (POAG). Setting: Surgical center (Augencentrum Köln, Köln, Germany). Design: Retrospective analysis of 106 eyes from 71 consecutive patients. Methods: Ab-interno canal viscodilation (VISCO360®) with or without cataract extraction was performed in two groups of patients with mild-moderate POAG: Group 1 had a baseline intraocular pressure (IOP) ≥18 mmHg (n=72 eyes) and Group 2 had a baseline IOP <18 mmHg (n=34 eyes). IOP without washout was measured and number of IOP-lowering medications were documented at all visits. Effectiveness was determined by reduction in IOP and reduction in the number of IOP-lowering medications at 12±3 months from baseline. Safety was determined by the rate of adverse events (AEs) and secondary surgical interventions (SSI). Results: In Group 1, all eyes available at 12±3 months (n=72), had a 41.0% reduction in mean IOP (from 24.6±7.1 mmHg to 14.6±2.8 mmHg), 87% (n=62) of which showed an IOP reduction of ≥20% with no increase in IOP-lowering medications. In Group 2, all eyes (n=34) maintained their baseline IOP at all postoperative visits. In both groups, a significant decrease (>89%) in mean number of IOP-lowering medications was seen at 12 months with 86% of eyes completely off medication with no increase in IOP. The most common AE seen was hyphema (13%) and no eye required SSI during the study period. Conclusion: Ab-interno SC viscodilation (VISCO360) is safe and effective in lowering IOP and reducing hypotensive medications in patients with OAG.

Clinical evaluation of aqueous outflow system in vivo and correlation with intraocular pressure before and after non-penetrating glaucoma surgery.

PURPOSE: The aim of this study was to evaluate the aqueous outflow system through channelography with fluorescein during non-penetrating glaucoma surgery (canaloplasty or phacocanaloplasty) and find correlations with preoperative and postoperative intraocular pressure (IOP). METHODS: Thirty-six patients (40 eyes) who had channelography while undergoing non-penetrating glaucoma surgery were included in this prospective study. Several parameters assessed during the channelography included: diffuse and superficial scleral staining, the number of visible superficial connections to collectors, trabecular permeability and number of micro-ruptures of the trabecular meshwork. IOP, the best-corrected visual acuity, the number of glaucoma medications was recorded at 1 day, 7 days, 3 months and 6 months after the operation. RESULTS: The change in IOP at 6 months from baseline significantly correlated with the number of visible superficial connections to collectors (r = 0.4, p = 0.021). Eyes with canaloplasty showed a mean baseline IOP of 19.4 (4.9) mmHg and mean glaucoma medication usage of 2.9 (1.0), which decreased to 13.2 (3.1) mmHg with 0.3 (0.8) medications, respectively, at 6 months postoperatively (p < 0.001). Eyes with phacocanaloplasty surgery showed a mean baseline IOP of 28.2 (9.6) mmHg with 2.6 (0.9) mean drugs, which decreased to IOP of 12.8 (3.4) mmHg with 0.5 (0.8) medications at 6 months (p < 0.001). CONCLUSION: A larger number of defined visible superficial connections to collectors after injection of fluorescein into SC is related to a more pronounced IOP decrease after non-penetrating glaucoma surgery.

Ab interno canaloplasty for the treatment of glaucoma: a case series study.

PURPOSE: To describe and evaluate the efficacy of ab interno canaloplasty (ABiC) in patients with primary open-angle glaucoma (POAG). METHODS: This single-center consecutive case series study included patients with cataract and open-angle glaucoma (combined procedure) and pseudophakic patients (mean age, 76 years; range, 66-83 years) with POAG who underwent ABiC using the iTrack™ 250-µm microcatheter (Ellex Medical Lasers Pty Ltd, Adelaide, Australia) to circumferentially viscodilate and intubate Schlemm's canal without placement of a tensioning suture. The primary endpoints were mean intraocular pressure (IOP) and mean number of glaucoma medications at 1, 3, 6, 9, and 12 months postoperatively. RESULTS: In total, 20 patients (20 eyes) were enrolled in the study. Mean IOP reduced from 18.5 ±â€¯3.44 mm Hg preoperatively to 14.88 ±â€¯2.82 mm Hg (n = 17), 13.80 ±â€¯2.05 (n = 12), 14.57 ±â€¯2.59 mm Hg (n = 9) and 15.47 ±â€¯2.42 (n = 6) at 1, 3, 6 and 9 months postoperatively. The 12­month data for two patients showed that IOP had reduced from 17 mm Hg preoperatively to 16 mm Hg in one patient and from 20 mm Hg to 13 mm Hg in the other patient. The mean number of medications was reduced from 2.4 preoperatively to 0.25 at the last follow-up visit. There was one reported complication of limited descemetolysis near the limbus by the viscoelastic during the dilatation of Schlemm's canal. No adverse events as a result of the device were reported. CONCLUSIONS: ABiC was straightforward to perform in this group of patients with minimal complications. Although initial findings from this study indicate that ABiC is comparable to conventional canaloplasty in lowering IOP and medication dependency, long-term follow-up in a large patient cohort is required to confirm the efficacy of this minimally invasive glaucoma procedure.

SURGICAL AND FUNCTIONAL RESULTS OF 27-GAUGE VITRECTOMY COMBINED WITH COAXIAL 1.8 MM MICROINCISION CATARACT SURGERY: A Consecutive Case Series.

PURPOSE: To investigate outcomes after coaxial 1.8 mm microincision cataract surgery combined with 27-gauge vitrectomy (MICVIT) in eyes with vitreoretinal disease and age-related cataract. METHODS: A single-center, retrospective case series study of 62 subjects (62 eyes) with a mean age of 70 years who underwent combined microincision phacoemulsification, intraocular lens implantation, and 27-gauge vitrectomy during the 12-month period to January 2015. Intraoperative and postoperative complications, and visual results were the main outcome measures. RESULTS: The mean follow-up period was 6 months (range 2-10 months). Intraoperative findings were retinal break (9.7%) and one posterior capsule tear (1.6%). No cases required corneal or scleral suture, or conversion to larger-gauge vitrectomy. Postoperative complications consisted of posterior capsule opacification (8%), elevated intraocular pressure >30 mmHg (6.4%), retinal detachment (1.6%), and fibrin reaction (1.6%). There were no cases of hypotony (<9 mmHg), intraocular lens decentration, or postoperative endophthalmitis. Visual acuity improved 3 Early Treatment of Diabetic Retinopathy Study (EDTRS) score lines from 0.48 ± 0.4 logMAR (20/60) preoperatively to 0.17 ± 0.23 logMAR (20/30) at final postoperative visit (P = 0.001). CONCLUSION: Findings suggest 27-gauge vitrectomy combined with microincision phacoemulsification and intraocular lens implantation is feasible, safe, and effective as a 1-step surgical procedure for the management of vitreoretinal pathologies and concurrent cataract.

Determination of a New Parameter, Elevated Epiretinal Membrane, by En Face OCT as a Prognostic Factor for Pars Plana Vitrectomy and Safer Epiretinal Membrane Peeling.

Purpose. To evaluate the significance of the area of epiretinal membrane (EM) that is not in contact with the retinal structure as a preoperative parameter for safer grasping of the EM and a prognostic factor for visual improvement/outcome. Methods. This prospective observational study included 73 consecutive patients (80 eyes) who underwent pars plana vitrectomy (PPV) and EM peeling. Corrected distance visual acuity (CDVA) and central foveal thickness (CFT) were evaluated preoperatively and at 12 months postoperatively. The number of initial peeling grasps was recorded in the operation protocol. The elevated EM portion was identified by en face optical coherence tomography (OCT) and processed digitally to calculate its area. Results. Surgery was found to significantly improve CDVA and decrease CFT. CDVA improvement correlated with elevated EM, preoperative CFT, and the number of grasping attempts. Conclusion. The detection of elevated EM via en face OCT could assist safer grasping of the EM and indicate the potential for visual outcome improvement after PPV and EM peeling.

Quality of life following glaucoma surgery: canaloplasty versus trabeculectomy.

PURPOSE: To evaluate quality of life (QoL) with a new questionnaire after canaloplasty (CP) and trabeculectomy (TE). PATIENTS AND METHODS: We assessed outcomes of surgery, rate of revision surgeries, patients' mood, and influence of postoperative care on QoL, surgery interference with daily activities, and postsurgical complaints. Patients completed the QoL questionnaire 24 months after surgery. RESULTS: Patients who underwent CP (n=175) were compared to TE patients (n=152). In the CP group, 57% of patients expressed high satisfaction, while 41% of patients in the TE group said they were highly satisfied. The satisfaction difference was statistically significant (P=0.034). Significantly fewer second surgeries were needed after CP (8% CP versus 35% TE, P<0.001). Patients were more positive in the CP group (54% CP versus 37% TE, P<0.009). Stress related to postoperative care was lower in the CP group compared to the TE group (14% versus 46%). Difficulties with activities of daily living, such as reading, were much lower or even nonexistent after CP, and complaints like eye burning or stinging were significantly lower in the CP group. CONCLUSIONS: Compared with TE, CP is associated with less QoL impairment and higher patient satisfaction after surgery. However, long-term data on intraocular pressure reduction after surgery are needed to confirm long-term patient satisfaction with this surgery.

Three-year canaloplasty outcomes for the treatment of open-angle glaucoma: European study results.

BACKGROUND: To report 3-year results investigating the safety and efficacy of canaloplasty, a procedure involving circumferential viscodilation of Schlemm's canal and tensioning of the inner canal wall to treat open-angle glaucoma. METHODS: This was a prospective, multi-center, interventional study of 109 eyes of 109 adult, open-angle glaucoma patients undergoing canaloplasty or combined cataract-canaloplasty surgery. Qualifying preoperative intraocular pressures (IOP) were at least 16 mmHg with historical IOPs of at least 21 mmHg with or without medical therapy. A flexible microcatheter was used to viscodilate the full circumference of the canal and to place a trabecular tensioning suture. Primary outcome measures included IOP, glaucoma medication usage, and adverse events. RESULTS: Eyes with canaloplasty showed a mean baseline IOP of 23.0 ± 4.3 mmHg and mean glaucoma medication usage of 1.9 ± 0.7 medications, which decreased to a mean IOP of 15.1 ± 3.1 mmHg on 0.9 ± 0.9 medications at 3 years postoperatively. Eyes with combined cataract-canaloplasty surgery showed a mean baseline IOP of 24.3 ± 6.0 mmHg on 1.5 ± 1.2 medications, which decreased to a mean IOP of 13.8 ± 3.2 mmHg on 0.5 ± 0.7 medications at 3 years. Intraocular pressure and medication use results for all study eyes were significantly decreased from baseline (p <0.00001) at all intervals. Late postoperative complications included cataracts (19.1%) and transient IOP elevation (1.8%). CONCLUSIONS: Canaloplasty demonstrated significant and sustained IOP reductions accompanied by an excellent short- and long-term safety profile in adult patients with open-angle glaucoma.

Circumferential viscodilation and tensioning of Schlemm canal (canaloplasty) with temporal clear corneal phacoemulsification cataract surgery for open-angle glaucoma and visually significant cataract: one-year results.

PURPOSE: To evaluate the safety and efficacy of circumferential viscodilation and tensioning of the inner wall of Schlemm canal, a new nonpenetrating surgical procedure (canaloplasty) to treat open-angle glaucoma (OAG), combined with clear corneal phacoemulsification and posterior chamber intraocular lens (IOL) implantation. SETTING: Multicenter surgical sites. METHODS: This international multicenter prospective study comprised adult patients with OAG having combined glaucoma and cataract surgery. Patients with qualifying treated preoperative intraocular pressure (IOP) of at least 21 mm Hg or higher and open angles were eligible. Evaluation was performed at baseline and 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively. Intraoperative and postoperative high-resolution ultrasound imaging was used to assess Schlemm canal and anterior segment angle morphology, including distension of the trabecular meshwork due to the tensioning suture. RESULTS: Data from 54 eyes that had combined glaucoma and cataract surgery performed by 11 surgeons at 9 study sites were analyzed for this interim analysis. The mean baseline IOP was 24.4 mm Hg+/-6.1 (SD) with a mean of 1.5+/-1.0 medications per eye. In all eyes, the mean postoperative IOP was 13.6+/-3.8 mm Hg at 1 month, 14.2+/-3.6 mm Hg at 3 months, 13.0+/-2.9 mm Hg at 6 months, and 13.7+/-4.4 mm Hg at 12 months. Medication use dropped to a mean of 0.2+/-0.4 per patient at 12 months. Surgical complications were reported in 5 eyes (9.3%) and included hyphema (n=3, 5.6%), Descemet tear (n=1, 1.9%), and iris prolapse (n=1, 1.9%). Transient IOP elevation of more than 30 mm Hg was observed in 4 eyes (7.3%) 1 day postoperatively. CONCLUSION: Circumferential viscodilation and tensioning of Schlemm canal combined with clear corneal phacoemulsification and posterior chamber IOL implantation was a safe and effective procedure to reduce IOP in adult patients with OAG.

Canaloplasty: circumferential viscodilation and tensioning of Schlemm's canal using a flexible microcatheter for the treatment of open-angle glaucoma in adults: interim clinical study analysis.

PURPOSE: To evaluate the safety and efficacy of circumferential viscodilation and tensioning of the inner wall of Schlemm's canal in a new surgical procedure for the treatment of open-angle glaucoma (OAG). SETTING: Fourteen clinical sites in the United States and Germany. METHODS: In this international multicenter prospective study of adult patients with OAG having glaucoma surgery, patients with qualifying preoperative intraocular pressure (IOP) of at least 16 mm Hg or higher and open angles were eligible. Evaluation was performed at baseline and 1 day, 1 week, and 1, 3, 6, and 12 months preoperatively. After a nonpenetrating dissection technique to expose Schlemm's canal was performed, a flexible microcatheter (iTrack 250A, iScience Interventional) was used to dilate the full circumference of the canal by injecting sodium hyaluronate 1.4% (Healon GV) during catheterization. A suture loop was placed in the canal to apply tension to the trabecular meshwork. High-resolution ultrasound imaging was used to assess Schlemm's canal and anterior segment angle morphology, including distension of the trabecular meshwork caused by the tensioning suture. Data analysis was performed in 2 groups: Group 1, in which patients met all inclusion criteria, and Group 2, made up of Group 1 patients who had successful suture placement. RESULTS: Group 1 comprised 94 patients and Group 2, 74 patients. The mean baseline IOP in Group 1 was 24.7 mm Hg+/-4.8 (SD) on a mean of 1.9+/-1.0 medications per patient. In Group 2 (patients with sutures), the mean IOP was 16.1+/-4.7 mm Hg 3 months postoperatively, 15.6+/-4.0 mm Hg at 6 months, and 15.3+/-3.8 mm Hg at 1 year. Medication use dropped to a mean of 0.6+/-0.9 per patient at 12 months. Suture tensioning was an apparent contributing factor in achieving surgical success. Patients with measurable trabecular meshwork distension from suture tension had a mean IOP of 15.9+/-5.2 mm Hg at 6 months and 14.5+/-3.0 mm Hg at 12 months. Surgical and postsurgical adverse events were reported in 15 of 94 patients (16%) and included hyphema (3), elevated IOP greater than 30 mm Hg (3), Descemet's tear (1), hypotony (1), choroidal effusion (1), and exposed closure suture with eyelid edema and erythema epiphora (1); 4 patients were subsequently converted to trabeculectomy. CONCLUSION: Circumferential viscodilation and tensioning of Schlemm's canal was a safe and effective surgical procedure to reduce IOP in adult patients with OAG.