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

Study Overview
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Brief Summary
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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
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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 .

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

Conditions
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Glaucoma, Angle-Closure

Intervention / Treatment
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* Procedure: ab interno trabeculectomy with Trabectome
* Procedure: trabeculectomy


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIT group<br>PACG in AIT group will receive ab interno trabeculectomy with Trabectome and before AIT, Laser Peripheral Iridectomy (LPI) will be performed first. | Procedure: ab interno trabeculectomy with Trabectome<br>* 123 PACG will be recruited to receive ab interno trabeculectomy with Trabectome and before this surgery, laser peripheral iridectomy will be performed firstly<br>|
| Active Comparator: Trab group<br>PACG in AIT group will receive trabeculectomy. | Procedure: trabeculectomy<br>* 123 PACG will be recruited to receive trabeculectomy to reduce IOP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate of IOP reduction | IOP ≤21mmHg and IOP reduction rate ≥20% with or without antiglaucoma medications and without additional glaucoma surgery | 12 months | 

Secondary Outcome Measures

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