Three-Year Outcomes of Trabeculotomy vs Combined Trabeculotomy-Trabeculectomy for Primary Congenital Glaucoma
In brief
Trabeculotomy is noninferior to combined surgery, with 82% success at 3 years
In a randomized trial of children with primary congenital glaucoma and corneas measuring 12 to 14 mm across, trabeculotomy achieved surgical success in 82% at 36 months, compared with 85% after combined trabeculotomy-trabeculectomy. Adverse event rates did not differ significantly; hyphema was most common and usually resolved on its own. The findings support trabeculotomy as an alternative for this specific group.
- Journal
- Ophthalmology (Q1)
- Published
- 5 November 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Lei Fang, Shufen Lin, Jian Zhang, Yingting Zhu, Minbin Yu, Mingkai Lin, et al.
- PMID
- 42988223
- DOI
- 10.1016/j.ophtha.2026.10.039
Why clinicians should know about it
- Picked for Ophthalmology (paper of the day, 6 November 2026): Randomized comparison of congenital glaucoma surgeries
Abstract
PURPOSE: To determine whether trabeculotomy is noninferior to combined trabeculotomy-trabeculectomy (CTT) for primary congenital glaucoma (PCG) with a horizontal corneal diameter (HCD) of 12-14 mm. DESIGN: Prospective, randomized, controlled noninferiority trial. PARTICIPANTS: Children from birth through 3 years of age with PCG, a HCD of 12 to 14 mm, and no previous intraocular or laser surgery were eligible. Two hundred and forty-eight children were enrolled from January 2015 through April 2021, and the final follow-up was completed in April 2024. METHODS: One eligible eye per child was randomly assigned in a 1:1 ratio to trabeculotomy or CTT. MAIN OUTCOME MEASURES: The primary outcome was qualified surgical success at 36 months, defined as an intraocular pressure (IOP) of 5 to 21 mmHg with or without glaucoma medications, without vision-threatening complications or additional glaucoma surgery. The noninferiority margin was -15 percentage points. Exploratory secondary outcomes included changes in IOP, ocular morphometric and functional outcomes, and adverse events. RESULTS: Overall, 124 children were assigned to trabeculotomy (mean age, 9.8 months; 76.6% male) and 124 to CTT (mean age, 9.9 months; 68.5% male). In the intention-to-treat population, qualified success at 36 months was achieved in 102 of 124 eyes (82.3%) in the trabeculotomy group and 105 of 124 eyes (84.7%) in the CTT group (risk difference: -2.4%; 95%CI, -11.7 to 6.9; Pnoninferiority= 0.004). Corresponding rates in the per-protocol population were 90.3% and 92.9%, respectively (risk difference -2.6%; 95%CI -10.3 to 4.9; Pnoninferiority< 0.001). Mean IOP reduction was -12.1 mm Hg (95%CI, -12.9 to -11.4) and -13.2 mm Hg (95%CI, -14.0 to -12.4) in the trabeculotomy and CTT groups, respectively (P=0.067). No statistically significant between-group differences were observed in other secondary outcomes. Adverse events occurred in 56 children (45.2%) in the trabeculotomy group and 67 (54.0%) in the CTT group (P = 0.162). Hyphema was the most common adverse event in both groups, and most cases resolved spontaneously. CONCLUSIONS: Trabeculotomy was noninferior to CTT for qualified surgical success at 36 months in PCG patients with a HCD of 12-14 mm. These findings suggest that trabeculotomy may be an alternative to CTT in this population.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.