{Reference Type}: Clinical Trial Protocol
{Title}: Trabeculotomy versus combined trabeculotomy-trabeculectomy for primary congenital glaucoma: study protocol of a randomised controlled trial.
{Author}: Fang L;Guo X;Yang Y;Zhang J;Chen X;Zhu Y;Huang J;Huang J;Zhong Y;Xu X;Liu X;
{Journal}: BMJ Open
{Volume}: 10
{Issue}: 2
{Year}: 02 2020 25
{Factor}: 3.006
{DOI}: 10.1136/bmjopen-2019-032957
{Abstract}: 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.<BR>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.<BR>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.<BR>Chinese Clinical Trial Registry, ChiCTR-IOR-14005588; Date registered: 20 November 2014.