Bleb-Independent Glaucoma Surgery to Activate the Uveolymphatic Route of Non-Trabecular Aqueous Humor Outflow: Short-Term Clinical and OCT Results

The deep sclerectomy technique was modified to enhance aqueous humor (AH) outflow via the non-trabecular pathway. A pilot study was carried out to assess its safety and effectiveness. Thirty-eight patients were under observation. After superficial scleral flap (4 × 4 mm), deep scleral layers were divided into three parts by three parallel-to-limbus incisions. Deep sclerectomy without creating a window in the Descemetes’ membrane was carried out in the distal part. A collagen implant was placed under the sclera of the remaining two parts with one end in the intrascleral pool. The third proximal part was excised to expose the uvea and implant. A Nd:YAG laser trabeculotomy at the surgery site was made on postoperative days 7–10. Outcome measures were IOP change, use of hypotensive medication(s), complications, and the need for a second surgery. At six months, the mean IOP decreased from 29.1 ± 9.2 mm Hg to 14.0 ± 4.3 mm Hg (p = 1.4 × 10−9); hypotensive medication use reduced from 2.9 ± 0.9 to 0.6 ± 1.0 (p = 1.3 × 10−10); complete success was achieved in 68.4% of cases and partial success was achieved in 31.6% of cases. Intraoperative and postoperative complications were rare and manageable. The OCT of the surgery site revealed the absence of bleb in all cases. Lymphatic vessels with characteristic bicuspid valves in their lumen were detected in conjunctiva near the operation site and over it in 32 patients. IOP decrease in the proposed technique was achieved by activation of the uveolymphatic route of AH outflow.

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.

Safety and performance of a suprachoroidal sensor for telemetric measurement of intraocular pressure in the EYEMATE-SC trial

AimTo investigate the safety and performance of a telemetric suprachoroidal intraocular pressure (IOP) sensor (EYEMATE-SC) and the accuracy of its IOP measurements in open angle glaucoma (OAG) patients undergoing simultaneous non-penetrating glaucoma surgery (NPGS).MethodsProspective, multicentre, open-label, single-arm, interventional clinical trial. Twenty-four eyes of 24 patients with OAG regularly scheduled for NPGS (canaloplasty or deep sclerectomy) were simultaneously implanted with an EYEMATE-SC sensor. Six-month follow-up on the sensor’s safety and performance as well as on the level of agreement between the EYEMATE-SC measurements and IOP measurements with Goldmann applanation tonometry (GAT).ResultsThe eyes underwent canaloplasty (n=15) or deep sclerectomy (n=9) and achieved successful implantation of the sensor. No device migration, dislocation or serious device-related complications occurred. A total of 367 comparisons were included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 1.31 mm Hg (lower limit of agreement (LoA) 7.55 mm Hg; upper LoA –4.92 mm Hg). The maximum difference of 2.5 mm Hg ±3.96 (LoA 0.30–2.29) was reached on day 10 and continuously improved to an agreement of –0.15 mm Hg ±2.28 (LoA –1.24 to 0.89) after 6 months. Accordingly, the percentage of eyes within an IOP difference of ±5 mm Hg improved from 78% (day 3) to 100% (6 months).ConclusionsAfter 6 months, the EYEMATE-SC sensor was safe and well tolerated, and allowed continual IOP monitoring.Trial registration numberNCT03756662.

Experience in the management of patients with cataract-associated glaucoma

Purpose. Analysis of the effectiveness of surgical treatment of patients with primary open-angle glaucoma associated with cataract the first stage realization of cataract phacoemulsification with IOL implantation (PHACO), and the second stage - microinvasive nonpenetrating deep sclerectomy (MNPDS). Material and methods. The results of 234 cases of performing PHACO and MNPDS at various stages have been analyzed. The main group included patients who underwent PHACO, followed by MNPDS – 39 persons, 40 eyes. The group was divided into a subgroup based on the date of the second intervention. 1 subgroup – patients who underwent MNPDS 1 month after PHACO (11 cases); 2 subgroup – 3 months after PHACO (29 cases). The control group included patients who underwent MNPDS followed by PHACO – 180 persons, 195 eyes. Also, subgroups of patients were identified for whom PHACO + IOL was performed in the second stage after 1 month – 1 subgroup (99 cases) and after 3 months – 2 subgroup (96 cases). Results. Patients of the main group showed a significant decrease in intraocular pressure after each stage of treatment. in the control group, intraocular pressure decreased after the first stage of treatment, but increased 6 months after surgery. Conclusions. According to the study, in primary open-angle glaucoma associated with cataract, the most persistent hypotensive effect is observed when the first stage of cataract phacoemulsification is performed, and the second stage is antiglaucoma surgical intervention. Key words: glaucoma, cataract, cataract phacoemulsification, microinvasive nonpenetrating deep sclerectomy.

Immunohistochemical identification of lymphatic outflow in filtering blebs after non-penetrating deep sclerectomy (NPDS)

Relevance. One of the conditions for the functional outflow pathways' formation after filtering glaucoma surgeries is the uniform moisture absorption from the filtering blebs, which is provided by the blood and, possibly, lymphatic vessels of the conjunctiva. Purpose. To conduct a structural and molecular assessment of filtering blebs in patients with open-angle glaucoma (OAG) after non-penetrating deep sclerectomy (NPDS) according to OCT data, as well as ultrastructural and immunohistochemical studies. Material and methods. A clinical study of 12 patients with primary open-angle glaucoma (POAG) after NPDS was conducted. In the long-term postoperative period (12–18 months), the level of intraocular pressure (IOP) was determined, the structure of the filtering blebs using biomicroscopy and OCT of the anterior segment of the eye was evaluated, the immunohistochemical study of the filtering blebs' tissue for the expression of podoplanin and ultrastructural analysis of the samples obtained using a laser confocal microscope LSM 710 (Zeiss) was performed. In 8 cases (group 1), these were non-functional scarred filtering blebs, IOP 24.12± 2.24 mm Hg, in 4 cases (group 2) – functional filtering blebs, IOP 15.31± 4.08 mm Hg. Results. During the immunohistochemical examination of the first group patients' conjunctival samples, no vessels with characteristics of the lymphatic system were detected in any case. In each sample of the second group patients' filtering blebs, from 5 to 7 vessels with different variants of podoplanin expression were determined. Conclusion. The aqueous outflow entering the subconjunctival space through the newly created outflow pathway during glaucoma surgery is carried out at the expense of conjunctival lymphatic structures, the condition of which to a certain extent determines the success or failure of the surgery. Key words: non-penetrating deep sclerectomy; open-angle glaucoma; lymphatic outflow; filtering blebs

Refractive Astigmatism in Phaco-Canaloplasty vs Phaco-Non-Penetrating Deep Sclerectomy in 24-months Period, in a Randomized, Prospective Study.

PurposeThis study aimed to assess refractive astigmatism, in Phaco-Canaloplasty (PC) vs Phaco-Non-Penetrating Deep sclerectomy (PDS) in a randomized, prospective study within 24 months.MethodsPatients were randomized pre-operatively, 37 underwent PC and 38 PDS. The following data was collected: BCVA, IOP, number of antiglaucoma medications, refraction with autokeratorefractometry. The assessment of astigmatism was simple arithmetic and vector analysis included double angle plots and cumulative refractive astigmatism graphs.ResultsPre-operative mean BCVA in PC was 0.40±0.43 and was comparable to BCVA in PDS 0.30±0.32logMAR (P=0.314). In the sixth month follow-up, mean BCVA showed no difference (P=0.708) and was 0.07±0.13 and 0.05±0.11, respectively. However, two years after the intervention mean BCVA was better in PC 0.05±0.12 than in PDS 0.12±0.23 and it was statistically significant (P=0.039). Mean astigmatism in PC at baseline was 1.13±0.73Dcyl and 1.35±0.91 for PDS(P=0.544). At six months it was 1.09±0.61 and 1.24±0.86 respectively,(P=0.595). At two years 1.17±0.51 for PC and 1.24±0.82(P=0.917). The direction of mean astigmatism was against the rule throughout observation for both groups. Centroids pre-operatively were 0.79D@172˚±1.10Dcyl in PC and 0.28D@10˚±1.63D in PDS. At six months 0.75D@166˚±1.01 and 0.26D@11˚±1.5, respectively. At 24-months 0.64D@164˚±1.11 and 0.47D@20˚±1.43. The mean baseline IOP in PC was 19.4±5.8mmHg and 19.7±5.4mmHg in PDS(P=0.639). From the six-month IOP was lower in PC, at 24-months it was 13.8±3.3mmHg in PC and 15.1±2.9mmHg in PDS(P=0.048). In both groups preoperatively patients used median(Me) of 3 antiglaucoma medications(P=0.197), at 24-months in PC mean 0.5±0.9 Me=0.0 and 1.1±1.2 Me=1.0 in PDS(P=0.058). ConclusionsBoth surgeries in mid-term observation are safe and effective. They do not generate vision-threatening astigmatism and don’t even change the preoperative direction of mean astigmatism. Refractive astigmatism is stable throughout the observation.

Microcatheter-Assisted Trabeculotomy Combined With Deep Sclerectomy and Trabeculectomy in Young to Middle-Aged Adults With Advanced Primary Open-Angle Glaucoma: 1-Year Result

Objective: We aimed to evaluate the safety and clinical efficacy of ab externo microcatheter-assisted trabeculotomy combined with deep sclerectomy and trabeculectomy (MATT-DS-Trab) in the surgical management of advanced primary open-angle glaucoma (POAG).Methods: According to the inclusion criteria, we retrospectively collected and analyzed 37 POAG cases in advanced stage who received MATT-DS-Trab. The intraocular pressure (IOP), best corrected visual acuity (BCVA), use of anti-glaucoma drugs, shape of the filtering bleb, size of the scleral lake, complications, and the surgical success rate were recorded.Results: The mean IOP was 37.50 ± 8.11 mmHg before the operation, while it depleted to 10.08 ± 2.01 and 11.43 ± 2.07 mmHg at 1 week and 12 months after the operation, respectively (both P &lt; 0.001 compared to preoperative IOP). From none to two kinds of anti-glaucoma drugs were used 12 months after surgery on the patients, which were significantly reduced compared with that preoperatively (P &lt; 0.001). An L-type filtering bleb was the main form at all time points after the operation. At 12 months following surgery, an F-type filtering bleb accounted for 5.41% and no E-type filtering bleb was recorded. The length and height of the scleral lake shrunk with time, but there was no statistical significance (P &gt; 0.05). Also, there was no correlation between the size of the scleral pool and the IOP (P &gt; 0.05). At 12 months after the operation, the complete success rates were 94.59, 83.78, and 72.97% according to standards A (≤18 mmHg), B (≤15 mmHg), and C (≤12 mmHg), respectively. Intraoperative complications were mainly anterior chamber hemorrhage, and no complications related to the filtration bleb were observed after the operation.Conclusion: Based on multichannel mechanisms, MATT-DS-Trab is able to effectively reduce IOP in advanced POAG patients, with few serious complications and a high success rate.

Changes in Ocular Surface Disease Evaluated after Nonpenetrating Deep Sclerectomy

Objective: To analyse the ocular surface changes in eyes after the withdraw of anti-glaucomatous drugs when non-penetrating deep sclerectomy (NPDS) is performed.Methods: 31 patients (33 eyes) diagnosed of glaucoma that underwent NPDS, were included in this prospective study. Control group included 33 eyes of 33 age and sex-matched volunteers. Five variables were studied with Keratograph 5M (K5M): ocular hyperaemia (OH), non-invasive tear film break-up time (NI-BUT), lower tear meniscus height (LTMH) and meibography. LTMH was also measured using the anterior segment module of Spectralis Fourier-Domain Optical Coherence Tomography (FD-OCT). Also, an evaluation of corneal and conjunctival staining was performed.In addition, patients were asked to answer two questionnaires: Ocular Surface Disease Index (OSDI) and National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) before and 6-months after surgery.Results: Before NPDS, treated eyes, showed worse objective data than healthy controls (p ≤0.049). In this group, a significant improvement was observed in the questionnaires (p< 0.001), LTMH FD-OCT (p=0.037) and LTMH K5M (p=0.025), K5M OH (p=0.003), NI-BUT (=0.022) and conjunctival and corneal staining (p<0.001). No significant differences were observed between groups in FD-OCT and K5M LTMH, NI-BUT, corneal-conjunctival staining and in the most OH sector values at 6 months(p ≥0.62).Conclusion: A significant improvement in the ocular surface was observed 6 months after NPDS, suggesting that the withdrawn of the topical anti-glaucomatous treatment has a beneficial effect.