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Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy

Primary Purpose

Glaucoma, Angle-Closure

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lens extraction combined with goniosynechialysis
Trabeculectomy surgery
Sponsored by
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Angle-Closure focused on measuring phacoemulsification, goniosynechialysis, trabeculectomy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 40 years old to 80 years old
  2. more than 180-degree synechial closure of anterior chamber angle on gonioscopy
  3. IOP higher than 21mmHg under the use of more than two anti-glaucoma eye drops
  4. mean deviation of visual field worse than -12dB on Humphrey 24-2
  5. phakic eyes

Exclusion Criteria:

  1. Snellen visual acuity worse than 0.02
  2. history of ocular trauma
  3. uveitis
  4. previous ocular surgeries
  5. significant conjunctival scar
  6. visible neovascular on iris or anterior chamber angle
  7. other severe eye diseases that would affect visual function significantly, such as age-related macular degeneration and pathogenic myopia.

Sites / Locations

  • Eye & ENT HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lens extraction combined with goniosynechialysis group

Trabeculectomy Group

Arm Description

One hundred and fifty-eight patients with advanced angle-closure glaucoma underwent phacoemulsification combined with goniosynechialysis.

One hundred and fifty-eight patients with advanced angle-closure glaucoma underwent trabeculectomy.

Outcomes

Primary Outcome Measures

Intraocular pressure (IOP) change at one month
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one month.
IOP change at three months
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three months.
IOP change at six months
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at six months.
IOP change at one year
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one year.
IOP change at two years
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at two years.
IOP change at three years
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three years.
Best corrected visual acuity at one month
Best corrected visual acuity of participants after surgery at one month
Best corrected visual acuity at three months
Best corrected visual acuity of participants after surgery at three months
Best corrected visual acuity at six months
Best corrected visual acuity of participants after surgery at six months
Best corrected visual acuity at one year
Best corrected visual acuity of participants after surgery at one year
Best corrected visual acuity at two years
Best corrected visual acuity of participants after surgery at two years
Best corrected visual acuity at three years
Best corrected visual acuity of participants after surgery at three years

Secondary Outcome Measures

Mean deviation
The mean deviation value of Humphery visual filed tests before and after surgery.
The thickness of retinal nerve fiber layer (RNFL)
The RNFL thickness measured by optical coherence topography (OCT)
The thickness of ganglion cell complex (GCC)
The GCC thickness measured by OCT
Number of eye drops
The number of eye drops after surgery.
Adverse event
Adverse events of each group, such as cornea edma, ocular hypotension, hemorrhage

Full Information

First Posted
January 3, 2021
Last Updated
February 28, 2023
Sponsor
Eye & ENT Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04703712
Brief Title
Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy
Official Title
Effectiveness of Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy in Treating Advanced Angle-closure Glaucoma: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye & ENT Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the effectiveness of lens extraction combined with goniosynechialysis and trabeculectomy in treating advanced angle-closure glaucoma.
Detailed Description
Advanced angle closure glaucoma (AACG) can result in severe visual function defect or even blindness with or without acute attacks. Different from open angle glaucoma (OAG), the main principle of treatment for AACG is not only to lower intraocular pressure (IOP) but also to protect the anterior chamber angle from closing. Previously, the most common and classical treatment for AACG was trabeculectomy. However, both doctors and patients are not satisfied with this surgery because of its limited success rate due to fibrosis of the filtration pathway. Besides, trabeculectomy has various complications, such as shallow anterior chamber, choroidal effusion, suprachoroidal hemorrhage, malignant glaucoma, and bleb leakage associated endophthalmitis. In addition, patients who underwent trabeculectomy will have decreased visual acuity in a couple of years due to accelerated development of cataract. Since a thickened and anterior-positioned lens could play a crucial role in the pathogenesis of AACG, cataract surgery has also been used. Accumulative evidence shows lens extraction alone is an efficient way in treating the early stage of ACG but has limited success rate in AACG. Lens extraction combined with goniosynechialysis (LEG) has been proved to be better than lens extraction alone in re-opening the anterior chamber angle for ACG patients with extensive peripheral anterior synechia and possibly have better effect than trabeculectomy as well from our preliminary data, which has not been proved yet. Thus, this investigation is designed to compare the effect of LEG and trabeculectomy in AACG patients prospectively in 3 years of follow-up. The investigators hypothesize that LEG could have better IOP control and better visual function than trabeculectomy in long term for AACG patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Angle-Closure
Keywords
phacoemulsification, goniosynechialysis, trabeculectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
316 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lens extraction combined with goniosynechialysis group
Arm Type
Active Comparator
Arm Description
One hundred and fifty-eight patients with advanced angle-closure glaucoma underwent phacoemulsification combined with goniosynechialysis.
Arm Title
Trabeculectomy Group
Arm Type
Active Comparator
Arm Description
One hundred and fifty-eight patients with advanced angle-closure glaucoma underwent trabeculectomy.
Intervention Type
Procedure
Intervention Name(s)
Lens extraction combined with goniosynechialysis
Intervention Description
The patients enrolled underwent phacoemulsification combined with goniosynechialysis surgery.
Intervention Type
Procedure
Intervention Name(s)
Trabeculectomy surgery
Intervention Description
The patients enrolled underwent trabeculectomy surgery
Primary Outcome Measure Information:
Title
Intraocular pressure (IOP) change at one month
Description
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one month.
Time Frame
one month
Title
IOP change at three months
Description
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three months.
Time Frame
three months
Title
IOP change at six months
Description
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at six months.
Time Frame
six months
Title
IOP change at one year
Description
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one year.
Time Frame
one year
Title
IOP change at two years
Description
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at two years.
Time Frame
two years
Title
IOP change at three years
Description
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three years.
Time Frame
three years
Title
Best corrected visual acuity at one month
Description
Best corrected visual acuity of participants after surgery at one month
Time Frame
one month
Title
Best corrected visual acuity at three months
Description
Best corrected visual acuity of participants after surgery at three months
Time Frame
three months
Title
Best corrected visual acuity at six months
Description
Best corrected visual acuity of participants after surgery at six months
Time Frame
six months
Title
Best corrected visual acuity at one year
Description
Best corrected visual acuity of participants after surgery at one year
Time Frame
one year
Title
Best corrected visual acuity at two years
Description
Best corrected visual acuity of participants after surgery at two years
Time Frame
two years
Title
Best corrected visual acuity at three years
Description
Best corrected visual acuity of participants after surgery at three years
Time Frame
three years
Secondary Outcome Measure Information:
Title
Mean deviation
Description
The mean deviation value of Humphery visual filed tests before and after surgery.
Time Frame
one month, three months, six months, one year, two years, three years
Title
The thickness of retinal nerve fiber layer (RNFL)
Description
The RNFL thickness measured by optical coherence topography (OCT)
Time Frame
one month, three months, six months, one year, two years, three years
Title
The thickness of ganglion cell complex (GCC)
Description
The GCC thickness measured by OCT
Time Frame
one month, three months, six months, one year, two years, three years
Title
Number of eye drops
Description
The number of eye drops after surgery.
Time Frame
one month, three months, six months, one year, two years, three years
Title
Adverse event
Description
Adverse events of each group, such as cornea edma, ocular hypotension, hemorrhage
Time Frame
one month, three months, six months, one year, two years, three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 40 years old to 80 years old more than 180-degree synechial closure of anterior chamber angle on gonioscopy IOP higher than 21mmHg under the use of more than two anti-glaucoma eye drops mean deviation of visual field worse than -12dB on Humphrey 24-2 phakic eyes Exclusion Criteria: Snellen visual acuity worse than 0.02 history of ocular trauma uveitis previous ocular surgeries significant conjunctival scar visible neovascular on iris or anterior chamber angle other severe eye diseases that would affect visual function significantly, such as age-related macular degeneration and pathogenic myopia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Gao, Doctor
Phone
(86)021-64377134
Email
fenggao@fudan.edu.cn
Facility Information:
Facility Name
Eye & ENT Hospital
City
Shanghai
ZIP/Postal Code
200031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Gao, Doctor
Phone
021-64377134
Email
fenggao@fudan.edu.cn

12. IPD Sharing Statement

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Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy

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