Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy

Effectiveness of Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy in Treating Advanced Angle-closure Glaucoma: a Randomized Controlled Trial

To compare the effectiveness of lens extraction combined with goniosynechialysis and trabeculectomy in treating advanced angle-closure glaucoma.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma, Angle-Closure
• Intervention / Treatment: Procedure: Lens extraction combined with goniosynechialysis; Procedure: Trabeculectomy surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 316
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Feng Gao, Doctor; Phone Number: (86)021-64377134; Email: fenggao@fudan.edu.cn

Study Locations

• China
  • Shanghai, China, 200031
    • Recruiting
    • Eye & ENT Hospital
    • Contact: Feng Gao, Doctor; Phone Number: 021-64377134; Email: fenggao@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lens extraction combined with goniosynechialysis group; One hundred and fifty-eight patients with advanced angle-closure glaucoma underwent phacoemulsification combined with goniosynechialysis.	Procedure: Lens extraction combined with goniosynechialysis; The patients enrolled underwent phacoemulsification combined with goniosynechialysis surgery.
Active Comparator: Trabeculectomy Group; One hundred and fifty-eight patients with advanced angle-closure glaucoma underwent trabeculectomy.	Procedure: Trabeculectomy surgery; The patients enrolled underwent trabeculectomy surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean deviation	The mean deviation value of Humphery visual filed tests before and after surgery.	one month, three months, six months, one year, two years, three years
The thickness of retinal nerve fiber layer (RNFL)	The RNFL thickness measured by optical coherence topography (OCT)	one month, three months, six months, one year, two years, three years
The thickness of ganglion cell complex (GCC)	The GCC thickness measured by OCT	one month, three months, six months, one year, two years, three years
Number of eye drops	The number of eye drops after surgery.	one month, three months, six months, one year, two years, three years
Adverse event	Adverse events of each group, such as cornea edma, ocular hypotension, hemorrhage	one month, three months, six months, one year, two years, three years

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 3, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: phacoemulsification; trabeculectomy; goniosynechialysis
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Angle-Closure
• Other Study ID Numbers: AAC Glaucoma

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No