
Винод Кумар
Born and schooling in Delhi, India. Graduation, post graduation, Ph.D. and D.Sc (medicine) in USSR/Russian federation. Presently professor of ophthalmology at Peoples' friendship university of Russia and head of ophthalmic unit of Skhodnya city hospital, Khimki, Moscow province.
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Joel Schuman
NYU School of Medicine
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Material. A total of 50 glaucoma cases were operated upon. In all cases MCai was performed. In the study group (29 cases), to keep the cyclodialysis cleft open, after MCai a SMI was implanted. Rest 21 cases served as control. Surgically, ciliary body was gently detached from sclera at 45 o’clock position with the help of a specially designed spatula inserted through a clear corneal incision, creating a cleft of 2,5 mm wide and 56 mm deep. Outcome measures: IOP change, use of hypotensive me dications, need for repeat glaucoma surgery and complications. Minimum followup period – 18 months.
Results. Baseline IOP, which was 28.9 ± 4.7 и 30.2 ± 7.2 mmHg in study and control groups respectively, at 18 months redu ced to 19.6 ± 1.6 (р = 2Е08) and 20 ± 1.4 mmHg (p = 0.0006). Use of hypotensive medications reduced from 2.7 ± 0.8 to 1.1 ± 0.9 (р = 1Е06) in study group and from 2.6 ± 0.9 to 0.8 ± 0.7 (р = 2Е05) in control group. There was no statistically significant difference between groups in relation to decrease in IOP and use of hypotensive medications. Overall success in study group was 86 %, in control group – 67 % (p = 0.12). Failure rate was 14 % in study group and 33 % – in control group (p = 0.006).
Conclusion. MCai is effective in decreasing IOP and in reducing use of hypotensive medications, however MCai followed by implantation of a SMI reduces significantly number of cases requiring repeat glaucoma surgery.
METHODS: A total of 9 cases (9 eyes) having visually significant cataract and insufficiently controlled by their current ocular hypotensive medication(s) glaucoma were operated upon. There were 5 cases of pseudoexfoliation syndrome, rigid pupils and weakening of Zinn’s ligaments resulting in instability of native lens and requiring implan-tation of a capsule tension ring (CTR) into the capsular bag to stabilize it. A one-stage combined surgery — phaco-emulsification with in-the-bag implantation of a foldable acrylic hydrophilic intraocular lens (IOL) and implantation of SCE in Schlemm’s canal (SC) was performed in all cases. A 4-5 mm long SCE made from 0.05mm thick medical grade vanadium stainless steel wire was implanted into the SC lumen by ab externo approach. Primary outcome measure was intraocular pressure (IOP) change, secondary — num-ber of glaucoma medications pre- and postoperatively and complications. A paired t-test was used for IOP and medi-cation analysis. 25% decrease in IOP or IOP of 18 mm Hg or less without medication was considered a complete suc-cess, with medication — partial success. The need for sub-sequent filtering surgery was qualified as failure. Success was evaluated on the basis of Kaplan-Meier cumulative probability at each follow-up visit. Results were considered statistically significant with p<0.05. Minimum postoperative follow-up was 18 months.
RESULTS: Out of 9 operated cases a total of 7 cases (7 eyes) were included for analysis. 1 patient who died of natural causes 3 months after the surgery and another case with incomplete follow up were excluded from the study. Mean preoperative IOP was 26.1±4.6 mm Hg (range: 19.0-30.9;5% CI 22.7-29.5) and mean number of preoperative medi-cations was 2.1±0.4 (range: 2–3; 95% CI 1.9-2.4). At each follow-up a decrease in mean IOP was observed, resulting in 11.3+3.0 mmHg (range: 7.1-15.3; CI 9.1-13.5) at 18 months (p=0.0000015). This represents a reduction of 56.3±11.6% from the baseline IOP. A reduction in glaucoma medica-tions use was observed at each follow up visit and was 0.9+1.2 (range: 0-3; 95% CI 0.0-1.8) at 18 months (p=0.016). Complete and partial success was observed in 4 and 3 cases at the 18-month point, respectively. Microperforation of the trabecular meshwork (TM) in areas other than the exposed part of SC occurred in 1 case. In 5 cases the device could be pushed into SC completely. In 2 cases one end (0.5 to 1.0 mm in length) of the device was left in the exposed part of SC. No specific complications related to the device were noted. A filtration bleb was noticed in 5 cases on day one, 2 cases at 1 week and 1 case at 1 month. At 3 months and afterwards no filtration bleb was noticed in any of the cases. In 1 case laser capsulotomy for secon- dary cataract was performed to restore vision. Goniosco-pically the device was in the lumen of the SC in all cases except the case with intra-operative microperforation, where one end of the device was lying in the anterior cham-ber (AC) without any contact with intraocular structures.
CONCLUSION: Eighteen months results of the SCE implantation in surgical management of OAG in cataract patients show significant reduction in IOP from the base-line and in hypotensive medication(s) use.
KEYWORDS: Schlemm’s canal surgery, Schlemm’s ca- nal expander, stainless steel spiral Schlemm’s canal expander, glaucoma surgery, open angle glaucoma, mini invasive glaucoma surgery, combined surgery for cataract and glaucoma.
METHODS: Nine consecutive patients (9 eyes) having failed filters (failed trabeculectomy — 6 cases, failed deep sclerectomy — 2 cases and failed selective laser trabecu-loplasty — 1 case), who’s IOP was insufficiently controlled, were operated upon. A 2.5-3.0 mm long stainless steel spi-ral 2nd generation SCE made from 0.04mm thick medical grade stainless steel wire, having outer diameter of 0.2 mm and inner lumen diameter of 0.12 mm was implanted into Schlemm’s canal (SC) ab externo. Two patients (2 eyes) with coexisting cataract and glaucoma underwent a combined procedure. Patients were evaluated daily during hospital stay, after 1 week, and at 1, 3, 6 and 12 months after surgery. IOP was considered a primary outcome measure. Secondary outcome measures were as follows: the number of glaucoma medications pre- and postoperatively and complications. A paired t-test was used for IOP and medication analysis. Decrease in IOP >20% or IOP from 6 to 18 mmHg without medication was considered a complete success, with medi-cation — partial success. Failure was declared if the patient had IOP < 6 mmHg or > 18 or reduction in IOP was <20% after 3 months and if patient needed a subsequent filter-ing surgery. Success rates were evaluated at each follow-up visit after 3 months after surgery. Statistical analysis was performed using MS office application — Excel 2007 at each follow-up visit taking into account the change in the number of patients. Results were considered significant with p<0.05.RESULTS: Mean (mean±standard deviation (SD)) preope-rative IOP was 25.2±5.5 mmHg. At each follow-up a decrease in mean IOP was observed, resulting in 12.5±3.9 mmHg (p=.00003) at 6 months and 12.9±1.4 mmHg (p=.00009) at 12 months. This represents a reduction in IOP from baseline of 49.4±17.4 and 44.2±9.8% at 6 and 12 months respectively. Mean number of used medications decreased from base-line 2.4±1.0 to 1.4±1.0 (p=0.05) and 1.0±1.0 (p=0.03) at 6 and 12 months respectively. Complete and partial success were observed in 2 and 6 cases (n=9) at 3 months, in 2 and 7 cases (n=9) at 6 months and 2 and 3 cases (n=5) at 12 months. There was only 1 case at 3 months, who fulfilled the failure criteria. There were no failure cases at 6 and 12 months. Intraoperative microperforation of trabecular meshwork (TM) in areas other than exposed part of SC occurred in 1 case. In 7 cases the device could be inserted completely into SC lumen. In 2 cases the caudal end (0.5 mm) of the device was left in the exposed part of SC. In the early post-operative period a bleb was noticed in 3 cases at 1 week and in 1 case at 1 and 3 months each. Complications like device dislocation, inflammation at the implanta-tion site, devices’ erosion through TM, loss of device were nil. YAG laser trabeculopucture was not required in any of the cases.
CONCLUSION: Kumar’s 2nd generation SCE is effective in decreasing IOP in patients with primary OAG refractory to previous penetrating and non-penetrating glaucoma surgeries. Use of medications is significantly reduced after implantation of this device.
KEYWORDS: Schlemm’s canal surgery, Schlemm’s canal expander, glaucoma surgery, refractory glaucoma surgery.
Material. A total of 50 glaucoma cases were operated upon. In all cases MCai was performed. In the study group (29 cases), to keep the cyclodialysis cleft open, after MCai a SMI was implanted. Rest 21 cases served as control. Surgically, ciliary body was gently detached from sclera at 45 o’clock position with the help of a specially designed spatula inserted through a clear corneal incision, creating a cleft of 2,5 mm wide and 56 mm deep. Outcome measures: IOP change, use of hypotensive me dications, need for repeat glaucoma surgery and complications. Minimum followup period – 18 months.
Results. Baseline IOP, which was 28.9 ± 4.7 и 30.2 ± 7.2 mmHg in study and control groups respectively, at 18 months redu ced to 19.6 ± 1.6 (р = 2Е08) and 20 ± 1.4 mmHg (p = 0.0006). Use of hypotensive medications reduced from 2.7 ± 0.8 to 1.1 ± 0.9 (р = 1Е06) in study group and from 2.6 ± 0.9 to 0.8 ± 0.7 (р = 2Е05) in control group. There was no statistically significant difference between groups in relation to decrease in IOP and use of hypotensive medications. Overall success in study group was 86 %, in control group – 67 % (p = 0.12). Failure rate was 14 % in study group and 33 % – in control group (p = 0.006).
Conclusion. MCai is effective in decreasing IOP and in reducing use of hypotensive medications, however MCai followed by implantation of a SMI reduces significantly number of cases requiring repeat glaucoma surgery.
METHODS: A total of 9 cases (9 eyes) having visually significant cataract and insufficiently controlled by their current ocular hypotensive medication(s) glaucoma were operated upon. There were 5 cases of pseudoexfoliation syndrome, rigid pupils and weakening of Zinn’s ligaments resulting in instability of native lens and requiring implan-tation of a capsule tension ring (CTR) into the capsular bag to stabilize it. A one-stage combined surgery — phaco-emulsification with in-the-bag implantation of a foldable acrylic hydrophilic intraocular lens (IOL) and implantation of SCE in Schlemm’s canal (SC) was performed in all cases. A 4-5 mm long SCE made from 0.05mm thick medical grade vanadium stainless steel wire was implanted into the SC lumen by ab externo approach. Primary outcome measure was intraocular pressure (IOP) change, secondary — num-ber of glaucoma medications pre- and postoperatively and complications. A paired t-test was used for IOP and medi-cation analysis. 25% decrease in IOP or IOP of 18 mm Hg or less without medication was considered a complete suc-cess, with medication — partial success. The need for sub-sequent filtering surgery was qualified as failure. Success was evaluated on the basis of Kaplan-Meier cumulative probability at each follow-up visit. Results were considered statistically significant with p<0.05. Minimum postoperative follow-up was 18 months.
RESULTS: Out of 9 operated cases a total of 7 cases (7 eyes) were included for analysis. 1 patient who died of natural causes 3 months after the surgery and another case with incomplete follow up were excluded from the study. Mean preoperative IOP was 26.1±4.6 mm Hg (range: 19.0-30.9;5% CI 22.7-29.5) and mean number of preoperative medi-cations was 2.1±0.4 (range: 2–3; 95% CI 1.9-2.4). At each follow-up a decrease in mean IOP was observed, resulting in 11.3+3.0 mmHg (range: 7.1-15.3; CI 9.1-13.5) at 18 months (p=0.0000015). This represents a reduction of 56.3±11.6% from the baseline IOP. A reduction in glaucoma medica-tions use was observed at each follow up visit and was 0.9+1.2 (range: 0-3; 95% CI 0.0-1.8) at 18 months (p=0.016). Complete and partial success was observed in 4 and 3 cases at the 18-month point, respectively. Microperforation of the trabecular meshwork (TM) in areas other than the exposed part of SC occurred in 1 case. In 5 cases the device could be pushed into SC completely. In 2 cases one end (0.5 to 1.0 mm in length) of the device was left in the exposed part of SC. No specific complications related to the device were noted. A filtration bleb was noticed in 5 cases on day one, 2 cases at 1 week and 1 case at 1 month. At 3 months and afterwards no filtration bleb was noticed in any of the cases. In 1 case laser capsulotomy for secon- dary cataract was performed to restore vision. Goniosco-pically the device was in the lumen of the SC in all cases except the case with intra-operative microperforation, where one end of the device was lying in the anterior cham-ber (AC) without any contact with intraocular structures.
CONCLUSION: Eighteen months results of the SCE implantation in surgical management of OAG in cataract patients show significant reduction in IOP from the base-line and in hypotensive medication(s) use.
KEYWORDS: Schlemm’s canal surgery, Schlemm’s ca- nal expander, stainless steel spiral Schlemm’s canal expander, glaucoma surgery, open angle glaucoma, mini invasive glaucoma surgery, combined surgery for cataract and glaucoma.
METHODS: Nine consecutive patients (9 eyes) having failed filters (failed trabeculectomy — 6 cases, failed deep sclerectomy — 2 cases and failed selective laser trabecu-loplasty — 1 case), who’s IOP was insufficiently controlled, were operated upon. A 2.5-3.0 mm long stainless steel spi-ral 2nd generation SCE made from 0.04mm thick medical grade stainless steel wire, having outer diameter of 0.2 mm and inner lumen diameter of 0.12 mm was implanted into Schlemm’s canal (SC) ab externo. Two patients (2 eyes) with coexisting cataract and glaucoma underwent a combined procedure. Patients were evaluated daily during hospital stay, after 1 week, and at 1, 3, 6 and 12 months after surgery. IOP was considered a primary outcome measure. Secondary outcome measures were as follows: the number of glaucoma medications pre- and postoperatively and complications. A paired t-test was used for IOP and medication analysis. Decrease in IOP >20% or IOP from 6 to 18 mmHg without medication was considered a complete success, with medi-cation — partial success. Failure was declared if the patient had IOP < 6 mmHg or > 18 or reduction in IOP was <20% after 3 months and if patient needed a subsequent filter-ing surgery. Success rates were evaluated at each follow-up visit after 3 months after surgery. Statistical analysis was performed using MS office application — Excel 2007 at each follow-up visit taking into account the change in the number of patients. Results were considered significant with p<0.05.RESULTS: Mean (mean±standard deviation (SD)) preope-rative IOP was 25.2±5.5 mmHg. At each follow-up a decrease in mean IOP was observed, resulting in 12.5±3.9 mmHg (p=.00003) at 6 months and 12.9±1.4 mmHg (p=.00009) at 12 months. This represents a reduction in IOP from baseline of 49.4±17.4 and 44.2±9.8% at 6 and 12 months respectively. Mean number of used medications decreased from base-line 2.4±1.0 to 1.4±1.0 (p=0.05) and 1.0±1.0 (p=0.03) at 6 and 12 months respectively. Complete and partial success were observed in 2 and 6 cases (n=9) at 3 months, in 2 and 7 cases (n=9) at 6 months and 2 and 3 cases (n=5) at 12 months. There was only 1 case at 3 months, who fulfilled the failure criteria. There were no failure cases at 6 and 12 months. Intraoperative microperforation of trabecular meshwork (TM) in areas other than exposed part of SC occurred in 1 case. In 7 cases the device could be inserted completely into SC lumen. In 2 cases the caudal end (0.5 mm) of the device was left in the exposed part of SC. In the early post-operative period a bleb was noticed in 3 cases at 1 week and in 1 case at 1 and 3 months each. Complications like device dislocation, inflammation at the implanta-tion site, devices’ erosion through TM, loss of device were nil. YAG laser trabeculopucture was not required in any of the cases.
CONCLUSION: Kumar’s 2nd generation SCE is effective in decreasing IOP in patients with primary OAG refractory to previous penetrating and non-penetrating glaucoma surgeries. Use of medications is significantly reduced after implantation of this device.
KEYWORDS: Schlemm’s canal surgery, Schlemm’s canal expander, glaucoma surgery, refractory glaucoma surgery.