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. 2020 Feb 25;10(2):e032957.
doi: 10.1136/bmjopen-2019-032957.

Trabeculotomy versus combined trabeculotomy-trabeculectomy for primary congenital glaucoma: study protocol of a randomised controlled trial

Lei Fang  1 , Xinxing Guo  1   2 , Yangfan Yang  1 , Jian Zhang  1 , Xiangxi Chen  1   3 , Yingting Zhu  1 , Jielei Huang  1   4 , Jingjing Huang  1 , Yimin Zhong  1 , Xiaoyu Xu  1 , Xing Liu  5
Affiliations

Trabeculotomy versus combined trabeculotomy-trabeculectomy for primary congenital glaucoma: study protocol of a randomised controlled trial

Lei Fang et al. BMJ Open. .

Abstract

Introduction: Trabeculotomy and combined trabeculotomy-trabeculectomy (CTT) are major surgical options for primary congenital glaucoma (PCG). However, it is unclear which of these two surgical procedures should be recommended as the optimum first-line treatment for PCG. This trial aims to determine whether the outcomes of trabeculotomy are non-inferior to those of CTT in moderate PCG with a horizontal corneal diameter (HCD) of 12-14 mm.

Methods and analysis: This is a 3-year, non-inferiority, prospective, randomised controlled trial. We plan to recruite 248 participants (aged ≤3 years) with PCG with an HCD of 12-14 mm from the Department of Glaucoma, Zhongshan Ophthalmic Center, Guangzhou, China. One eye per participant will be randomly (1:1) assigned to receive trabeculotomy or CTT. The primary outcome is the 3-year postoperative success rate in lowering intraocular pressure (IOP), and the secondary clinical outcomes will include IOP reduction, visual acuity, HCD, central corneal thickness, axial length, cup-disc ratio, refractive error and postoperative complications. Data will be analysed by the intention-to-treat principle.

Ethical approval and dissemination: The study protocol has been approved by the ethics committee of Zhongshan Ophthalmic Center (2014MEKY023) and the '5010 Plan' evaluation committee at Sun Yat-Sen University, Guangzhou, China. The results will be disseminated in international academic meetings and published in peer-reviewed journals.

Trial registration number: Chinese Clinical Trial Registry, ChiCTR-IOR-14005588; Date registered: 20 November 2014.

Keywords: PCG; combined trabeculotomy-trabeculectomy; primary congenital glaucoma; randomised controlled trial; trabeculotomy.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Flow chart of the study. CTT, combined trabeculotomy–trabeculectomy.
See this image and copyright information in PMC

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