Fang 2020.

Study name	Trabeculotomy versus combined trabeculotomy–trabeculectomy for primary congenital glaucoma: study protocol of a randomised controlled trial
Methods	Study design: randomized controlled trial Number randomized (total and per group): target 248 participants Length of follow‐up: Planned: 3 years Actual: unknown
Participants	Country: China Age: equal to or under 3 years of age (planned) Gender: not reported Inclusion criteria: diagnosis of primary congenital glaucoma in either eye, equal to or under 3 years of age, horizontal corneal diameter between 12 and 14 mm, and no previous intraocular surgery or laser treatment Exclusion criteria: inability of the patient's legal guardian to give informed consent, inability of the patient to return to the clinic for the scheduled study visits, contraindications to anesthesia or surgery for ocular disease, severe corneal cloudiness precluding anterior chamber visualization, secondary congenital glaucoma, other coexisting ocular diseases such as an abnormal cornea, congenital iris abnormality, congenital cataract, or retinopathy of prematurity
Interventions	Intervention 1: combined trabeculotomy‐trabeculectomy Intervention 2: trabeculotomy
Outcomes	Primary outcome: success rate in lowering IOP Secondary outcome: IOP reduction and changes in the morphometric and functional parameters of eyeball: horizontal corneal diameter, corneal transparency, central corneal thickness, cup‐to‐disc ratio, axial length, visual acuity and refraction, and complications
Starting date	January 2015
Contact information	Xing Liu; +86 13660009887; drlx1987@163.com
Notes	Chinese Clinical Trial Registry: ChiCTR‐IOR‐14005588