Retrospective analysis of the success and safety of Gold Micro Shunt Implantation in glaucoma.

BACKGROUND: To evaluate the success rate and adverse effects of Gold Micro Shunt Plus (GMS+) implantation into the supraciliary space. METHODS: This retrospective study included 31 eyes of 31 patients diagnosed with severe glaucoma and uncontrolled intraocular pressure (IOP) with implantation of a GMS+ by means of a full-thickness scleral flap. The main outcome measures were surgical failure or success, based on the intraocular pressure and adverse effects. Clinical examination data are reported up to 4 years postoperatively. RESULTS: Thirty eyes (97%) met one of our criteria for failure. Within a mean of 7.3 ± 7.7 months another surgery was performed because of elevated IOP in 24 of 31 eyes (77%) and because of adverse effects in 2 (6%). The remaining 4 eyes, that met one of our criteria for failure, had an IOP reduction of less than 20% with comparable medication. Six GMS+'s were explanted; because of IOP elevation, 2; rubeosis iridis, 2; and low grade inflammation, 2. CONCLUSIONS: GMS+ implantation is not an effective method to control IOP in patients with glaucoma, when using our surgical technique. The reason for the found signs of chronic low grade inflammation or rubeosis iridis in 4 eyes (13%) remains unknown and has to be further investigated.

Capsule excision and Ologen implantation for revision after glaucoma drainage device surgery.

BACKGROUND: There is little information available about surgical management after failed glaucoma drainage device (GDD) surgery. We present the outcome of capsule excision after failed GDD surgery compared to capsule excision with additional use of a biodegradable implant (Ologen, version 2) as a placeholder. METHODS: In an observational comparative case series of 19 patients undergoing excision of the GDD capsule, ten prospectively observed consecutive patients were treated by excision of the capsule, topical mitomycin C application, and implantation of an 10 x 10 x 2 mm-sized Ologen implant (group A) while 9 retrospectively observed consecutive patients were treated by excision of the capsule and topical mitomycin C application alone (group B). RESULTS: Mean preoperative IOP was 29.4 mmHg for group A and 27.6 mmHg for group B, while mean postoperative IOP at the last follow-up (mean follow-up 11.2 (group A) and 8.6 (group B) months) was 17.3 mmHg for group A and 19.3 mmHg for group B (p > 0.05). Follow-up of the two groups demonstrated a significant difference in success rate (log-rank test, p = 0.04) in favor of group A. No further pressure-reducing surgery was necessary in any of the patients in group A, but it was needed in three of nine patients in group B. CONCLUSIONS: Although our study has the limitations of small sample size and observational study design, it shows that further investigation is warranted into the potential of Ologen in revision surgery after GDD implantation.

A prospective trial of phaco-trabeculotomy combined with deep sclerectomy versus phaco-trabeculectomy.

BACKGROUND: Combined phacoemulsification, intraocular lens implantation, and trabeculectomy (PTE) is currently the standard procedure for most ophthalmic surgeons to treat uncontrolled open-angle glaucoma and cataract at one time. This study was designed to prospectively compare a new technique of phaco-trabeculotomy plus deep sclerectomy (PDSTO) with standard phaco-trabeculectomy (PTE). METHODS: A consecutive series of 43 patients with uncontrolled open-angle glaucoma and cataract underwent combined glaucoma and cataract surgery. The procedure started as a two-site approach with phacoemulsification and IOL implantation through a temporal incision in clear cornea. Trabeculotomy and deep sclerectomy were performed in the superior quadrant. Trabeculectomy was also performed in the superior quadrant as a modified Cairns trabeculectomy. Postoperatively, examinations were performed on a daily base for 1 week. Follow-up visits were applied 1, 3, 6, and 12 months after surgery. RESULTS: The mean preoperative intraocular pressure (IOP) was 26.5 mmHg (SD 7.8) for all patients enrolled. The mean IOP was 12.3 mmHg (SD 5.1) 1 day post surgery for the PTE group (p < 0.001) and 14.4 mmHg (SD 4.0) for the PDSTO group (p < 0.001). At 12 months post surgery the success rate according to the Advanced Glaucoma Intervention Study (AGIS), defined as an IOP lower than 18mmHg without medication, was 20% in the PTE group and 50% in the PDSTO group (p = 0.03). The number of postoperative complications was equally low for both groups. No severe complications, such as bleb infection, endophthalmitis, or choroidal hemorrhage were seen in this series. CONCLUSIONS: PDSTO offered significant IOP reduction and a success rate which was higher than that of the current standard, PTE. The specific intra- and postoperative complications of deep sclerectomy, trabeculotomy, and trabeculectomy were seen in our series, although the overall rate of postoperative complications proved low.

Combined cataract-glaucoma surgery using the intracanalicular Eyepass glaucoma implant: first clinical results of a prospective pilot study.

PURPOSE: To study prospectively the safety and pressure-reducing efficacy of the Y-shaped Eyepass glaucoma implant (GMP Vision Solutions, Inc.). SETTING: Departments of Ophthalmology, University of Cologne, Cologne, and University of Erlangen, Erlangen, Germany. METHODS: This study comprised 12 patients with primary open-angle or exfoliative glaucoma and cataract who had phacoemulsification with endocapsular implantation of a foldable intraocular lens and intracanalicular implantation of an Eyepass glaucoma implant. The implant is a silicone microtube shunt that bypasses the trabecular meshwork and connects the lumina of Schlemm canal with the anterior chamber in combined cataract-glaucoma surgery. Perioperative complications, intraocular pressure (IOP), and pressure-reducing topical medications were monitored over a preliminary follow-up. RESULTS: Perforation of the trabecular meshwork during Eyepass implantation occurred in 2 eyes; the antiglaucoma procedure was converted to trabeculotomy after the shunt was explanted, and both eyes were excluded from further follow-up. In the remaining 10 eyes, the mean maximum IOP was 30.4 mm Hg +/- 7.5 (SD) (range 21 to 46 mm Hg) preoperatively, 12.0 +/- 6.1 mm Hg (range 2 to 20 mm Hg) 1 day postoperatively, 17.2 +/- 4.1 mm Hg (range 12 to 27 mm Hg) at 4 weeks, and 18.3 +/- 4.5 mm Hg (range 12 to 25 mm Hg) at the end of the preliminary follow-up. The mean number of topical medications was 3.2 +/- 0.8 preoperatively and 0.9 +/- 0.7 at the end of follow-up (mean 7.1 months). Although there were no major complications requiring surgical revision, 4 eyes had an IOP of 18 or higher at the end of follow-up. CONCLUSION: Combined cataract surgery with Eyepass shunt implantation was safe and appeared to be beneficial in glaucomatous eyes with cataract not requiring a low target IOP.

Phaco-trabeculotomy combined with deep sclerectomy, a new technique in combined cataract and glaucoma surgery: complication profile.

PURPOSE: Combined phacoemulsification, intraocular lens implantation and trabeculectomy (PTE) is currently the standard procedure for most ophthalmic surgeons for treating uncontrolled open-angle glaucoma and cataract at the same time. The present pilot study was designed to prospectively evaluate outcomes in glaucoma patients who underwent a new technique of phaco-trabeculotomy plus deep sclerectomy, with particular attention to the complication profile. METHODS: A consecutive series of 15 patients with uncontrolled open-angle glaucoma and cataract underwent combined glaucoma and cataract surgery. The procedure started as a two-site approach with phacoemulsification and intraocular lens (IOL) implantation through a temporal incision in clear cornea. Trabeculotomy and deep sclerectomy were performed in the superior quadrant. Postoperative examinations were performed daily for 1 week. Follow-up visits were carried out at 1, 3, 6 and 12 months after surgery. RESULTS: At 1 day post-surgery, mean intraocular pressure (IOP) was significantly reduced to 14.2 mmHg (SD 4.4). At 12 months post-surgery, the complete success rate, defined as IOP < 22 mmHg without medication, was 60%. Qualified success was achieved in 93.3% of patients. At 12 months post-surgery, the mean number of antiglaucoma medications had fallen to 0.4 (SD 0.6) (p < 0.001). Visual acuity improved by a mean value of 1.6 lines (SD 2.4) over baseline (p = 0.021). Specific complications such as choroidal deroofing, inadvertent perforation of the trabeculo-descemetic membrane, and non-identification of Schlemm's canal were seen among the patients in our trial. The incidence of complications due to overfiltration was low. A relatively high incidence of hyphaemas (53%) was noted in this series. All the hyphaemas were trivial and resolved quickly. No severe complications, such as bleb infection, endophthalmitis or choroidal haemorrhage were seen in this series. CONCLUSIONS: Phaco-trabeculotomy plus deep sclerectomy offered significant IOP reduction and a success rate that may be comparable with that of the current standard, PTE. Intra- and postoperative complications specific to deep sclerectomy and trabeculotomy were seen in our series, although the overall rate of postoperative complications proved low. Prospective comparative trials are needed to assess which of PTE and phaco-trabeculotomy plus deep sclerectomy is more successful.

Cyclodialysis ab interno as a surgical approach to intractable glaucoma.

PURPOSE: In glaucoma filtration surgery, the problem of subconjunctival scarring has still not been satisfactorily solved. Suprachoroidal drainage of aqueous humour offers a promising, alternative option for intractable glaucoma. We here present a clinical study on the surgical approach of gonioscopic cyclodialysis ab interno. PATIENTS AND METHODS: Twenty-eight eyes of 20 patients with intractable glaucoma were included in this prospective, consecutive, case-control study. The eyes had had a mean of 4.4 +/- 2.4 previous antiglaucomatous interventions. Baseline intraocular pressure (IOP) was 34.3 +/- 10.5 mmHg despite maximum therapy. Under gonioscopic control, cyclodialysis ab interno was performed over two clock times to gain access to the suprachoroidal space. No additional trabecular meshwork surgery was performed. Success was defined as a lowering of IOP to below 21 mmHg without the need for further medication or intervention. RESULTS: Mean postoperative IOP was 14.6 +/- 12.4 mmHg. Mean follow-up (FU) for all eyes was 121.8 days. After a mean of 60 days, 21 eyes (75%) needed further surgical intervention. Qualified success was seen in four eyes (14.3%), with a mean FU of 383.6 days. Three eyes (10.7%) showed absolute success after a mean FU period of 202.7 days. In our series, we obtained the best results for phakic eyes, followed by pseudophakic and aphakic eyes. CONCLUSION: The results of this study do not provide convincing evidence of the functional efficacy of cyclodialysis ab interno. Nevertheless, the technique is easy to perform and offers safe and atraumatic access to the resorptive capability of the choroid. Conjunctival manipulation is avoided. Contrary to reports in the current literature, in our series, the best results were obtained for phakic eyes, though the small number of eyes included does not allow reliable statistics. Further studies will need to focus on the use of different space-retaining substances or a widening of the cyclodialysis cleft to improve surgical outcome.

A novel approach to suprachoroidal drainage for the surgical treatment of intractable glaucoma.

PURPOSE: In glaucoma surgery, scarring of the artificial fistula is the limiting factor for long-term control of intraocular pressure (IOP). Several devices and surgical techniques have been developed for artificial aqueous humor drainage in intractable glaucoma. The authors describe a novel surgical technique that uses a silicone tube as a shunt for aqueous flow from the anterior chamber to the suprachoroidal space. PATIENTS AND METHODS: Thirty-one eyes of 31 patients with uncontrollable refractory glaucoma were included in this prospective consecutive case-control study. Each eye had undergone an average of 3.5+/-1.9 previous interventions for glaucoma. The baseline IOP was 44.25+/-8.7 mm Hg despite maximum therapy. As in trabeculectomy, a limbus-based scleral flap was prepared. The suprachoroidal space was accessed via a deep posterior scleral flap. The silicone tube was inserted as an intrascleral connection from the anterior chamber to the suprachoroidal space. Cyclodialysis was avoided by this surgical approach. Success was defined as a lowering of IOP to below 21 mm Hg without the need for further medication or intervention. RESULTS: The mean functional shunt survival was 55.9+/-45.6 weeks. IOP was reduced to 12.9+/-5.2 mm Hg in 70% of all eyes after 30 weeks postoperatively. After 52 weeks, 60% of the eyes could be classified as representing success, and 76 weeks after surgery, 40% of the eyes still showed controlled IOP. In none of the eyes were severe postoperative hypotony or suprachoroidal bleeding observed. No localized or general inflammation or infection was seen in connection with the silicon tube. Two patients needed anterior chamber lavage because of bleeding. In 2 patients the tube had to be removed because of corneal endothelial contact. Shunt failure of the tube was caused in some cases by connective tissue formation at the posterior lumen of the tube. CONCLUSION: This novel surgical approach and the placement of the silicone tube described here have several advantages. Its intrascleral course minimizes the risk of conjunctival erosion and associated infections. No cyclodialysis is performed. Connection to the suprachoroidal space exploits the resorptive capability of the choroid. It guarantees drainage but also provides a natural counterpressure, avoiding severe postoperative hypotony. The suprachoroidal shunt presented here achieves good follow-up results in terms of IOP control. No serious complications have been observed. This new method promises to be an effective surgical technique and presents a new therapeutic option in intractable glaucoma. Fibroblast reaction obstructing the posterior lumen, seemed to be the only factor limiting drainage. Further studies and experiments will be needed to elucidate the exact physiologic mechanisms underlying the draining, the capacity and duration of the draining effect, and the histologic background of suprachoroidal scarring.

Late hypotony as a complication of viscocanalostomy: a case report.

BACKGROUND: We report a long-term hypotony syndrome after deep sclerectomy, associated with intermittent rise in intraocular pressure (IOP) due to steroid response. PATIENT PRESENTATION: A 55-year-old woman with high myopia (RE -9.25, LE -10.50) suffering from uncontrolled pigment open-angle glaucoma, despite laser trabeculoplasty and a cyclodestructive procedure, underwent an uneventful viscocanalostomy. FOLLOW-UP: Intraocular pressure was between 9 and 17 mm Hg with local steroid medication 5 times a day, but became unstable with steroid reduction to 3 times a day and the patient developed hypotonous IOP (3-5 mm Hg) in the fourth postoperative month. With intensification of local steroid therapy, IOP rose to 49 mm Hg, and a reduction in medication was followed by hypotony. The instability of IOP with steroid medication could not be controlled and the IOP response due to steroids diminished with time; a long-term hypotony syndrome with maculopathy developed. Surgical inspection 10 months later with repeated preparation of the scleral flap showed (like ultrasound biomicroscope examination) a normal status after viscocanalostomy, without signs of leakage. CONCLUSIONS: Late hypotony syndrome should be considered as a potential complication of viscocanalostomy, perhaps especially in cases of myopia and former cyclodestructive procedures. In our case, despite nonpenetrating glaucoma surgery, the steroid response at first observed indicated additional outflow via the trabecular meshwork. After some months it could not be provoked any longer, leaving us to consider whether a gradual change in the trabecular meshwork hinders steroid medication changing aqueous outflow facility.

Contact lens, hyperopia and endothelial changes. A case report.

INTRODUCTION: We report on a 62-year-old healthy woman who suffered from bilateral predescemetic opacities, where the underlying disorder could not be identified. She had bilateral keratopathy with corneal edema, a diffuse predescemetic avascular haze and deszemetic folds. Because of high hyperopia (right +7.50/left +7.75) she weared soft contact lenses for years. METHODS: Removal of contact lenses. Treatment with local steroids and tear substitutes. RESULTS: One year after cessation of contact lenses VA recovered from RE 0.3/LE 0.1 to 0.8/0.63, the deep stromal opacity cleared up, the corneal edema recessed slightly. DISCUSSION: The differential diagnosis concludes either a pure contact lens change that is not completely reversible or a possible posterior polymorphous dystrophy that worsens with long-term contact lens wear and improves on cessation.

Treatment of granular dystrophy with soft contact lenses.

PURPOSE: To prevent recurrence of granular dystrophy by treatment with soft contact lenses. METHODS: After penetrating keratoplasty, a soft contact lens was fitted in a 61-year-old woman patient with granular corneal dystrophy. The lens was worn continuously for 53 months. RESULTS: No recurrence was observed. However, the other eye, which was operated on first and not treated with a contact lens, showed severe recurrence of the underlying disease, with granular deposits in the stroma. CONCLUSIONS: Fitting of a soft contact lens should be considered in this disease after penetrating keratoplasty.

A prospective randomized trial of viscocanalostomy versus trabeculectomy in open-angle glaucoma: a 1-year follow-up study.

PURPOSE: To assess the intraocular pressure-lowering efficacy and the postoperative complication profile of viscocanalostomy versus trabeculectomy. PATIENTS AND METHODS: Sixty eyes of 60 patients with medically uncontrolled open-angle glaucoma were randomized either to the viscocanalostomy or to the trabeculectomy group of the trial. Viscocanalostomy was performed according to Stegmann's technique using high-molecular-weight sodium hyaluronate to fill the ostia of the Schlemm canal. For trabeculectomy, a modified Cairns-trabeculectomy was performed. Examinations were performed before surgery and postoperatively daily for 1 week. Follow-up visits were scheduled 1, 6, and 12 months after surgery. RESULTS: The mean (SD) preoperative intraocular pressure was 27.1 (7.1) mm Hg for all patients enrolled. One day after surgery, mean (SD) intraocular pressure was 15.9 (5.2) for the trabeculectomy group (P <0.001) and 15.7 (3.6) for the viscocanalostomy group (P <0.001), respectively. The success rate, defined as an intraocular pressure lower than 22 mm Hg without medication, was 56.7% in the trabeculectomy group and 30% in the viscocanalostomy group at 12 months postoperatively (P = 0.041). The number of postoperative complications was lower in the viscocanalostomy group than in the trabeculectomy group. CONCLUSIONS: In eyes with open-angle glaucoma, viscocanalostomy is less effective in reducing intraocular pressure than standard filtering surgery. However, postoperative complications are more frequent after filtering surgery.

Risk profile of deep sclerectomy for treatment of refractory congenital glaucomas.

OBJECTIVES: To evaluate the effectiveness and risk profile of deep sclerectomy in surgery for refractory congenital glaucoma. DESIGN: Retrospective non-comparative interventional case series. PARTICIPANTS AND INTERVENTIONS: Ten eyes of eight consecutive patients underwent deep sclerectomy for refractory congenital glaucoma. The procedure was converted to a trabeculectomy in four eyes and supplemented by a trabeculotomy in two eyes. Six eyes had primary congenital glaucoma, and four eyes had secondary congenital glaucoma. The patients' ages at the time of surgery in our department ranged from 8 months to 14 years. All eyes had a history of previous glaucoma surgery. MAIN OUTCOME MEASURES: The surgical outcome was assessed in terms of complication rate, intraocular pressure (IOP) change, need for surgical revision, or additional glaucoma medication. RESULTS: Preoperatively, the mean IOP was 31.9 mmHg (standard deviation [SD], 5.6 mmHg). At first follow-up 1 week after surgery, the mean IOP for all eyes was 12.7 mmHg (SD, 6.8 mmHg). The average reduction of IOP was statistically significant (P < 0.001). In accordance with the success criteria, all eyes were ultimately classified as failures. Average time to failure was 2.1 months (SD, 3.6 months). Specific complications were seen in terms of non-identification of Schlemm's canal (40%), choroidal deroofing (10%), and visible perforation of the trabeculodescemetic membrane (20%). Further complications were hyphema (40%), ocular hypotony (10%), vitreous hemorrhage (10%), and vitreous loss with subsequent retinal detachment (10%). CONCLUSIONS: Although deep sclerectomy may reduce the IOP in patients with refractory congenital glaucoma, this study indicates a specific risk profile associated with deep sclerectomy in surgery for refractory congenital glaucoma.