Shreyas Temkar1, Shikha Gupta1, Ramanjit Sihota1, Reetika Sharma1, Dewang Angmo1, Amar Pujari1, Tanuj Dada2. 1. Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. 2. Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. Electronic address: tanujdada@gmail.com.
Abstract
PURPOSE: To compare outcomes of illuminated microcatheter-assisted circumferential trabeculotomy vs combined mitomycin C-augmented trabeculotomy-trabeculectomy for primary congenital glaucoma. DESIGN: Prospective, randomized trial. METHODS: Of the 30 patients (60 eyes) analyzed with bilateral primary congenital glaucoma aged ≤2 years, 1 eye of each patient was randomized to: illuminated microcatheter-assisted trabeculotomy (Group I) or combined trabeculotomy with trabeculectomy augmented with mitomycin C (Group II). Primary outcome measure was intraocular pressure (IOP) reduction. Categorization into absolute success (IOP ≤15 mm Hg without medication) and qualified success (IOP ≤15 mm Hg with medication) was done. Secondary outcomes included change in corneal diameter and clarity, optic disc status, refraction, need for anti-glaucoma therapy, and occurrence of complications. RESULTS: Mean age of patients was 6.63 ± 5.74 months. IOP fell by 49.3% (22.25 ± 10.88 to 11.56 ± 3.33 mm Hg) in Group I and 46.6% in Group II (21.73 ± 8.89 to 11.60 ± 3.03 mm Hg) (P < .001 in both). At 1 year, absolute success was achieved in 86.7% (26/30) and 90.0% (27/30) in Groups I and II, respectively (P >.99) and qualified success in 93.3% (28/30) in both groups (P = 1). There was significant improvement in corneal clarity (P < .001) and cup-to-disc ratio (P ≤ .01) in both groups at 1 year. Though incidence of hyphema was significantly more in Group I (P = .0001), no vision-threatening complications occurred in either group. CONCLUSIONS:Illuminated microcatheter-assisted circumferential trabeculotomy achieved comparable surgical outcomes to mitomycin C-augmented combined trabeculotomy-trabeculectomy and may be recommended as the initial surgical procedure for primary congenital glaucoma.
RCT Entities:
PURPOSE: To compare outcomes of illuminated microcatheter-assisted circumferential trabeculotomy vs combined mitomycin C-augmented trabeculotomy-trabeculectomy for primary congenital glaucoma. DESIGN: Prospective, randomized trial. METHODS: Of the 30 patients (60 eyes) analyzed with bilateral primary congenital glaucoma aged ≤2 years, 1 eye of each patient was randomized to: illuminated microcatheter-assisted trabeculotomy (Group I) or combined trabeculotomy with trabeculectomy augmented with mitomycin C (Group II). Primary outcome measure was intraocular pressure (IOP) reduction. Categorization into absolute success (IOP ≤15 mm Hg without medication) and qualified success (IOP ≤15 mm Hg with medication) was done. Secondary outcomes included change in corneal diameter and clarity, optic disc status, refraction, need for anti-glaucoma therapy, and occurrence of complications. RESULTS: Mean age of patients was 6.63 ± 5.74 months. IOP fell by 49.3% (22.25 ± 10.88 to 11.56 ± 3.33 mm Hg) in Group I and 46.6% in Group II (21.73 ± 8.89 to 11.60 ± 3.03 mm Hg) (P < .001 in both). At 1 year, absolute success was achieved in 86.7% (26/30) and 90.0% (27/30) in Groups I and II, respectively (P >.99) and qualified success in 93.3% (28/30) in both groups (P = 1). There was significant improvement in corneal clarity (P < .001) and cup-to-disc ratio (P ≤ .01) in both groups at 1 year. Though incidence of hyphema was significantly more in Group I (P = .0001), no vision-threatening complications occurred in either group. CONCLUSIONS: Illuminated microcatheter-assisted circumferential trabeculotomy achieved comparable surgical outcomes to mitomycin C-augmented combined trabeculotomy-trabeculectomy and may be recommended as the initial surgical procedure for primary congenital glaucoma.