Clinical Efficacy and Safety of Minimally Invasive Glaucoma Surgery on Primary Angle Closure Glaucoma

Not Applicable

• Conditions: Glaucoma, Angle-Closure
• Interventions: Procedure: ab interno trabeculectomy with Trabectome; Procedure: trabeculectomy

• Registration Number: NCT02964676
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Brief Summary

To evaluate the clinical efficacy (intraocular pressure reduction , success rate, the number of antiglaucoma medication) and safety of ab interno trabeculectomy (AIT) with Trabectome in Chinese PACG .

Detailed Description

A randomized, single blind, positive parallel control study method was used.This prospective case series will recruit 246 Chinese POAG, 123 cases in the experimental group will receive AIT treatment and 123 cases in the control group will receive trabeculectomy(Trab) surgery.Measurements of intraocular pressure(IOP) , visual acuity, refraction, slit lamp examination of the anterior segment and fundus, optical coherence tomography(OCT) to detect retinal nerve fiber layer thickness, macular thickness, visual field, gonioscopy and ultrasonic biological microscopy (UBM) will be recorded.They will be followed up for 12 months. The main outcome is success rate of IOP reduction and the other outcome are the number of antiglaucoma medication and complications .

Study Timeline

• Status Verified: 2016-11
• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-16
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-28
• Study Start: 2017-01
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

• Primary Angle Closure Glaucoma (PACG) with visible trabecular meshwork from 90︒ to 180︒ on gonioscopy and IOP couldn't be controlled ≤21mmHg with pilocarpine eye drop only.
• willing to accept the antiglaucoma surgery
• volunteer to participate in this study and be able to follow up on time
• previous antiglaucoma filtering surgery or laser surgery(LPI, SLT) and previous cataract surgery were not ruled out

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Exclusion Criteria

• visual acuity lower than HM or central tubular visual field
• corneal edema or large pterygium affecting the observation of anterior angle
• the demarcation of the scleral process and trabecular meshwork is not clear on gonioscopy
• new vessels on the iris surface or in the anterior angle chamber
• the eye received surgery is the only eye with visual function, that is the contralateral eye is blind
• requiring long-term use of anticoagulant drugs for systemic reasons
• abnormal coagulation function
• with specific clear scar physique
• cannot participate in follow-up

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AIT group	ab interno trabeculectomy with Trabectome	PACG in AIT group will receive ab interno trabeculectomy with Trabectome and before AIT, Laser Peripheral Iridectomy (LPI) will be performed first.
Trab group	trabeculectomy	PACG in AIT group will receive trabeculectomy.

Primary Outcome Measures

Name	Time	Method
success rate of IOP reduction	12 months	IOP ≤21mmHg and IOP reduction rate ≥20% with or without antiglaucoma medications and without additional glaucoma surgery

Secondary Outcome Measures

Name	Time	Method
number of antiglaucoma medication	12 months	numbers of antiglaucoma medication will be recorded before surgery and 12 months follow up.
complication rate	12 months	all the complications related to the surgery will be evaluated and recorded.
24-hour IOP fluctuations	12 months	24-hour IOP fluctuations curve will be recorded before treatment and 12 months follow up.