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

Shanghai Eye Disease Prevention and Treatment Center

Status: Unknown

Conditions: Glaucoma, Angle-Closure

Treatments: Procedure: trabeculectomy; Procedure: ab interno trabeculectomy with Trabectome

Study type: Interventional

Funder types: Other

Identifiers

NCT02964676

YFZX2016002

Details and patient eligibility

About

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 .

Full 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 .

Enrollment: 246 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

246 participants in 2 patient groups

AIT group

Experimental group

Description:

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

Treatment:

Procedure: ab interno trabeculectomy with Trabectome

Trab group

Active Comparator group

Description:

PACG in AIT group will receive trabeculectomy.

Treatment:

Procedure: trabeculectomy