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

Primary Purpose

Glaucoma, Angle-Closure

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

ab interno trabeculectomy with Trabectome

trabeculectomy

About this trial

This is an interventional treatment trial for Glaucoma, Angle-Closure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AIT group

Trab group

Arm Description

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

PACG in AIT group will receive trabeculectomy.

Outcomes

Primary Outcome Measures

success rate of IOP reduction

IOP ≤21mmHg and IOP reduction rate ≥20% with or without antiglaucoma medications and without additional glaucoma surgery

Secondary Outcome Measures

number of antiglaucoma medication

numbers of antiglaucoma medication will be recorded before surgery and 12 months follow up.

complication rate

all the complications related to the surgery will be evaluated and recorded.

24-hour IOP fluctuations

24-hour IOP fluctuations curve will be recorded before treatment and 12 months follow up.

Full Information

NCT ID

NCT02964676

First Posted

November 14, 2016

Last Updated

November 23, 2016

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

1. Study Identification

Unique Protocol Identification Number

NCT02964676

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2017 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Eye Disease Prevention and Treatment Center

4. Oversight

Data Monitoring Committee

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Angle-Closure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

246 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AIT group

Arm Type

Experimental

Arm Description

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

Arm Title

Trab group

Arm Type

Active Comparator

Arm Description

PACG in AIT group will receive trabeculectomy.

Intervention Type

Procedure

Intervention Name(s)

ab interno trabeculectomy with Trabectome

Intervention Description

123 PACG will be recruited to receive ab interno trabeculectomy with Trabectome and before this surgery, laser peripheral iridectomy will be performed firstly

Intervention Type

Procedure

Intervention Name(s)

trabeculectomy

Intervention Description

123 PACG will be recruited to receive trabeculectomy to reduce IOP

Primary Outcome Measure Information:

Title

success rate of IOP reduction

Description

IOP ≤21mmHg and IOP reduction rate ≥20% with or without antiglaucoma medications and without additional glaucoma surgery

Time Frame

12 months

Secondary Outcome Measure Information:

Title

number of antiglaucoma medication

Description

numbers of antiglaucoma medication will be recorded before surgery and 12 months follow up.

Time Frame

12 months

Title

complication rate

Description

all the complications related to the surgery will be evaluated and recorded.

Time Frame

12 months

Title

24-hour IOP fluctuations

Description

24-hour IOP fluctuations curve will be recorded before treatment and 12 months follow up.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

LING GE, M.d.

Phone

+86-21-62717733

Ext

851

geling99@sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

XIAOLING FANG, M.d.

Phone

+86-21-62717733

Ext

811

fangxl0617@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

LING GE, M.d.

Organizational Affiliation

Shanghai Eye Disease Prevention and Treatment Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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