In vivo study comparing an X-shaped polymethylmethacrylate and a cylindrical collagen implant for deep sclerectomy.

BACKGROUND: Study in vivo characteristics of a polymethylmethacrylate (PMMA) implant compared to the standard cylindrical collagen implant for deep sclerectomy (DS). DESIGN: Six-month comparative study. SAMPLES: Twenty eyes of ten rabbits. METHODS: Eyes were randomized to have DS with PMMA implant in one eye and collagen implant in the opposite eye. The growth of the new subconjunctival drainage vessels was assessed by combined fluorescein and indocyanin green anterior segment angiography; intrascleral and subconjunctival blebs were imaged by ultrasound biomicroscopy (UBM). At six months, outflow facility (C) was measured by anterior chamber perfusion and portions of one side of the DS were compared to portions on the 180° opposite side and native sclera on histology. RESULTS: The mean IOP preoperatively and at one, four, twelve, and twenty-four weeks was comparable in both groups (P > 0.1). UBM showed a statistically insignificant quicker regression of the subconjunctival bleb as well as a durable intrascleral lake in the PMMA group (P > 0.05). New drainage vessels were initially observed one month after surgery; they were more numerous in the PMMA group on angiographic and histological findings at 6 months (P < 0.05). The mean C increased significantly after surgery compared to preoperative values (P < 0.05) and no difference was observed between the implants (0.24 ± 0.06 µl/min/mmHg [PMMA] and 0.23 ± 0.07 µl/min/mmHg [collagen implant]) (P = 0.39). CONCLUSIONS: Deep sclerectomy performed with PMMA or collagen implants showed similar IOP lowering effects, outflow facility increase, and degree of inflammatory reaction.

Long-term results of deep sclerectomy with collagen implant.

PURPOSE: To study prospectively the success rate and complications of deep sclerectomy with collagen implant (DSCI). SETTING: Glaucoma Unit, Department of Ophthalmology, Hôpital Ophtalmique Jules Gonin, University of Lausanne, Lausanne, Switzerland. METHODS: This nonrandomized prospective trial comprised 105 eyes of 105 patients with medically uncontrolled primary and secondary open-angle glaucoma. Visual acuity, intraocular pressure (IOP), and slitlamp examinations were performed before surgery and after surgery at 1 and 7 days, and 1, 3, 6, 9, 12, 18, 24, 30, 36, 48, 54, 60, 66, 72, 78, 84, 90, and 96 months. Visual field examinations were repeated every 6 months. RESULTS: Mean follow-up period was 64 months +/- 26.6 (SD). Mean preoperative IOP was 26.8 +/- 7.7 mm Hg, and mean postoperative IOP was 5.2 +/- 3.35 mm Hg at day 1 and 12 +/- 3 mm Hg at month 78. At 96 months, the qualified success rate (ie, patients who achieved IOP <21 mm Hg with and without medication) was 91%, and the complete success rate (ie, IOP <21 mm Hg without medication) was 57%. At 96 months, 34% of patients had an IOP <21 mm Hg with medication. Fifty-one patients (49%) achieved an IOP < or =15 mm Hg without medication. Neodymium:YAG goniopuncture was performed in 54 patients (51%); mean time of goniopuncture performance was 21 months, and mean IOP before goniopuncture was 20 mm Hg, dropping to 11 mm Hg after goniopuncture. No shallow or flat anterior chamber, endophthalmitis, or surgery-induced cataract was observed. However, 26 patients (25%) showed a progression of preexisting senile cataract (mean time 26 months; range 18 to 37 months). Injections of 5-fluorouracil were administered to 25 patients (23%) who underwent DSCI to salvage encysted blebs. Mean number of medications per patient was reduced from 2.3 +/- 0.7 to 0.5 +/- 0.7 (signed rank P<.0001). CONCLUSION: Deep sclerectomy with collagen implant appears to provide stable and reasonable control of IOP at long-term follow-up with few immediate postoperative complications.

24-hour intraocular pressure fluctuation monitoring using an ocular telemetry Sensor: tolerability and functionality in healthy subjects.

PURPOSE: To evaluate the tolerability, comfort, and reliability of the signal transmission of an ocular Sensor used for 24-hour intraocular pressure fluctuation monitoring in humans. PATIENTS AND METHODS: In this uncontrolled open trial involving 10 healthy volunteers, an 8.7-mm radius prototype ocular telemetry Sensor (SENSIMED Triggerfish, Lausanne, Switzerland) and an orbital bandage containing a loop antenna were applied and connected to a portable recorder after full eye examination. Best-corrected visual acuity and position, surface wetting ability, and mobility of the Sensor were assessed after 5 and 30 minutes, 4, 12, and 24 hours. Subjective wearing comfort was scored and activities documented in a logbook. After Sensor removal, a full eye examination was repeated and the recorded signal analyzed. RESULTS: The comfort score was high and did not fluctuate significantly over time. The mobility of the Sensor was limited across follow-up visits and its surface wetting ability remained good. Best-corrected visual acuity was significantly reduced during Sensor wear and immediately after its removal (from 1.07 before, to 0.85 after, P value 0.008). Three subjects developed a mild, transient corneal abrasion. In all but 1 participant, we obtained usable data of a telemetric signal recording with sufficient sensitivity to depict ocular pulsation. CONCLUSIONS: This 24-hour trial has encouraging results on the tolerability and functionality of the ocular telemetric Sensor for intraocular pressure fluctuation monitoring. Further studies with different Sensor radii conducted on a larger study population are needed to improve comfort, precision, and interpretation of the telemetric signal.

Combined Ex-PRESS LR-50/IOL implantation in modified deep sclerectomy plus phacoemulsification for glaucoma associated with cataract.

PURPOSE: This is a prospective study reporting on modified deep sclerectomy (DS) using the Ex-PRESS LR-50 in combined cataract and glaucoma surgery. METHODS: Twenty-four eyes of 24 patients with medically uncontrolled glaucoma underwent modified DS. After phacoemulsification and intraocular lens implantation, the Ex-PRESS LR-50 was inserted into the anterior chamber under a scleral flap. A partial posterior DS was performed to provide an intrascleral bleb. The complete success rate was intraocular pressure (IOP) without medication =18 mmHg; the qualified success rate was IOP =18 mmHg with or without medication. Postoperative bleb management (subconjunctival mitomycin C injections ± needling) was performed in case of postoperative hypertension or bleb fibrosis. RESULTS: Follow-up was 40.1±10.8 (mean ± SD) months. Preoperatively, IOP was 18.1±5.3 mmHg, best-corrected visual acuity (BCVA) was 0.6±0.3, and number of medications was 2.3±1.1. The IOP decreased by 25.4% at 24 months and by 27.0% at 48 months. At 24 months, 19 patients (86.3%) achieved a BCVA of 0.5 or better, and at 48 months the mean BCVA was 0.7±0.3. At the last visit, the mean number of medications was 0.6±0.8 (p<0.05). The complete and qualified success rates were 45.6% and 85.2%. Mitomycin C injections were performed in 5 eyes. No conjunctival erosions over the Ex-PRESS LR-50 were seen. CONCLUSIONS: The Ex-PRESS LR-50 inserted into the anterior chamber after modified DS efficiently lowers IOP in combined surgery, preventing conjunctival erosion, a significant complication when using this device without scleral flap coverage.

Ultrasound biomicroscopy images: long-term results after deep sclerectomy with collagen implant.

PURPOSE: The aim of this study was to understand the long-term outflow pathway mechanisms after deep sclerectomy - when collagen implant is resorbed - using ultrasound biomicroscopy (UBM). METHODS: Forty-three eyes of 32 patients with medically uncontrolled open-angle glaucoma at least 1 year after deep sclerectomy were studied in an observational, non-randomised, consecutive case series. Postoperatively 15 eyes (35.7%) had goniopuncture with the Nd:YAG laser. Four eyes (9.5%) had postoperative subconjunctival injections of mitomycin C and two eyes (4.7%) had an injection of 5-fluorouracil, because of intraocular pressure (IOP) increase. Complete examination and UBM of the filtering site were performed 1-6 years after surgery. The following parameters were assessed: (1) Presence of a subconjunctival filtering bleb; (2) presence and volume of an intrascleral cavity; (3) presence of a suprachoroidal hypoechoic area. RESULTS: Intraocular pressure decreased significantly from 28.1+/-2.5 mmHg preoperatively to 12.4+/-3.8 (range 7-25) mmHg at the time of UBM (at least 1 year after surgery). Forty eyes showed clinically a diffuse filtering bleb. UBM demonstrated a subconjunctival space in all eyes. In 39 eyes (92.8%) an intrascleral cavity was observed. The mean volume of this cavity was 1.8 (range 0.11-6.53) mm(3). In 19 eyes (45.2%) we observed a hypoechoic area in the suprachoroidal space. CONCLUSION: UBM examination demonstrated several aqueous humour drainage pathways. A low-reflective diffuse subconjunctival space meant persistent filtration in all eyes. More than 1 year after surgery 92.8% of eyes had a remaining intrascleral cavity. In almost half of the patients an additional suprachoroidal outflow was observed, significantly correlated with a lower IOP.