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

November 23, 2016 updated by: Shanghai Eye Disease Prevention and Treatment Center

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

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

246

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AIT group
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
123 PACG will be recruited to receive ab interno trabeculectomy with Trabectome and before this surgery, laser peripheral iridectomy will be performed firstly
Active Comparator: Trab group
PACG in AIT group will receive trabeculectomy.
Procedure: trabeculectomy
123 PACG will be recruited to receive trabeculectomy to reduce IOP

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Investigators

  • Principal Investigator: LING GE, M.d., Shanghai Eye Disease Prevention and Treatment Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 14, 2016

First Submitted That Met QC Criteria

November 14, 2016

First Posted (Estimate)

November 16, 2016

Study Record Updates

Last Update Posted (Estimate)

November 28, 2016

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YFZX2016002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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