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.

Treatment of Partial-Thickness Rotator Cuff Tears With a Resorbable Bioinductive Bovine Collagen Implant: 1-Year Results From a Prospective Multicenter Registry

Background: Surgical treatment of partial-thickness rotator cuff tears remains challenging and controversial, with several traditional options including debridement with acromioplasty, transtendon or in situ repair, and take-down and repair. A resorbable bioinductive bovine collagen implant has shown promise as an alternative treatment option for partial-thickness tears. Purpose: Data from a registry were analyzed to further establish that the implant contributes to improved patient-reported outcome (PRO) scores across a large number of patients treated for partial-thickness rotator cuff tears. Study Design: Case series; Level of evidence, 4. Methods: A total of 19 centers in the United States enrolled patients >21 years old with partial-thickness tears of the rotator cuff in a comprehensive prospective multicenter registry. PRO scores were recorded preoperatively and postoperatively at 2 and 6 weeks, 3 and 6 months, and 1 year: American Shoulder and Elbow Surgeons, Single Assessment Numeric Evaluation, Veterans RAND 12-Item Health Survey (physical and mental component scores), and Western Ontario Rotator Cuff scores. Revisions were reported throughout the study. Results: The registry included 272 patients with partial-thickness tears (49 grade 1 tears, 101 grade 2 tears, and 122 grade 3 tears), 241 who underwent isolated bioinductive repair (IBR; collagen implant placed after bursectomy without a traditional rotator cuff repair), and 31 who had take-down and repair with bioinductive augmentation. Patients experienced statistically significant and sustained improvement from baseline for all PRO scores beginning at 3 months. Among patients with grade ≥2 tears, those with take-down and repair had significantly inferior scores at 2 and 6 weeks for most PRO scores as compared with those who underwent IBR, but the difference was no longer significant at 1 year for all but the physical component score of the Veterans RAND 12-Item Health Survey. There were 11 revisions, which occurred at a mean ± SD of 188.7 ± 88.0 days after the index surgery. There were no infections. Conclusion: This registry analysis further establishes across a large data set that this resorbable bioinductive bovine collagen implant improves PROs in all grades of partial-thickness tears, whether used as IBR or in conjunction with take-down and repair. IBR may offer improved early clinical outcomes (≤6 weeks) and comparable outcomes at 1 year when compared with a more invasive “take-down and repair” approach.

Treatment of Partial-Thickness Rotator Cuff Repairs With A Resorbable Bioinductive Bovine Collagen Implant: 1-Year Results From A Prospective Multi-Center Registry

Objectives: Surgical treatment of partial-thickness rotator cuff tears remains challenging and controversial, with several traditional options including debridement with acromioplasty, transtendon or in-situ repair, and take-down and repair. A bioinductive resorbable bovine collagen implant has shown promise as an alternative treatment option for partial-thickness tears. It was our hypothesis that data from a comprehensive, prospective, multi-center registry will further establish the implant’s efficacy and safety across larger numbers of patients. Methods: Nineteen US centers enrolled patients >21 years old with partial-thickness tears of the rotator cuff. Patient-reported outcome (PRO) scores including the American Shoulder and Elbow Surgeons (ASES), single-assessment numeric evaluation (SANE), Veterans RAND 12-Item (VR-12) for both Physical Component Score (PCS) and Mental Component Score (MCS), and Western Ontario Rotator Cuff (WORC) outcome measures were recorded at pre-operative baseline, surgery, and postoperatively at 2 and 6 weeks, 3 and 6 months, and 1 year. Revisions were reported throughout the study. Results: The registry included 272 patients with partial-thickness tears (49 grade 1 tears, 101 grade 2 tears, and 122 grade 3 tears), 241 who underwent isolated bioinductive repair (“IBR”; collagen implant placed over the tear following bursectomy without a traditional rotator cuff repair - FIGURE 1) and 31 tradtitional take-down and repair with supplemental placement of the implant. Patients experienced statistically significant and sustained improvement from baseline for all PRO scores beginning at 3 months (TABLE 1). Among patients with grade ≥2 tears, those with take-down and repair had significantly inferior scores at 2 and 6 weeks for most PRO scores compared with those undergoing IBR, but the difference was no longer significant at 1 year for all but VR-12 PCS. There were 11 revisions, which occurred at a mean of 188.7 days (standard deviation, 88.0) after index surgery. Conclusions: Efficacy and safety of the implant are further established across a larger data set. IBR may offer improved early clinical outcomes and equivalent long-term results to supplemented take-down and repair, potentially with lower risk of complications. This implant can improve rotator cuff healing and clinical outcomes with minimal revisions. [Table: see text]

A Variant of Micro-Invasive Glaucoma Surgery: Calibrated Reverse Meridional Cyclodialysis ab interno Involving Implantation of a Non-Absorbable Collagen Implant

Purpose. To assess safety and effectiveness of calibrated cyclodialysis ab interno involving implantation of a non-absorbable collagen implant in the suprauveal space in decreasing IOP in glaucoma patients.Methods. Forty-three patients (43 eyes; 16 male and 27 females; average age — 70.4 ± 10.0 years) were included in this pilot study. A 6 mm long and 2.0 mm wide cyclodialysis cleft was created ab interno in one of the lower quadrants of the eye using a specially designed spatula followed by insertion of a strip of implant in the cleft. In 19 eyes (44.3 %) the procedure was performed as standalone procedure and in 24 eyes (55.7 %) along with cataract surgery. Outcome measures were IOP change, use of hypotensive medication(s), complications, and need for a second surgery. Decrease in IOP by >20 % and IOP between 6 and 21 mmHg without hypotensive medication(s) constituted complete success; similar changes in IOP with medication(s) constituted partial success. Need for second surgery constituted failure.Results. At 6 months, baseline IOP decreased from 20.6 ± 7.4 mmHg to 12.9 ± 4.9 mmHg (a decrease by 37.4 %; р < 0.001) and hypotensive medication use reduced from 2.6 ± 0.8 to 1.0 ± 1.1 (a reduction by 57.7 %; р < 0.001). Complete success was achieved in 19 eyes (44.2 %), partial in — 15 eyes (34.9 %). Nine eyes had unsuccessful outcomes (20.9 %); among these, seven eyes (78 %) had severe glaucoma and five eyes (55 %) had undergone previously glaucoma surgeries. Hemorrhaging at the cleft site was the most common intraoperative complication — 18 eyes (41.9 %). Postoperative complications included hyphema, which was completely resorbed within one week.Conclusion. Calibrated cyclodialysis ab interno procedure involving implantation of a non-absorbable collagen implant in the suprauveal is safe and easy to perform. It effectively decreases IOP in patients with moderate glaucoma but is less effective in patients with severe glaucoma and in patients with previously failed glaucoma surgeries. Complications were found to be minimal.