Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy

Not Applicable

Recruiting

• Conditions: Glaucoma, Angle-Closure
• Interventions: Procedure: Lens extraction combined with goniosynechialysis; Procedure: Trabeculectomy surgery

• Registration Number: NCT04703712
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2021-01-03
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-11
• Study Start: 2021-01-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 316

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lens extraction combined with goniosynechialysis group	Lens extraction combined with goniosynechialysis	One hundred and fifty-eight patients with advanced angle-closure glaucoma underwent phacoemulsification combined with goniosynechialysis.
Trabeculectomy Group	Trabeculectomy surgery	One hundred and fifty-eight patients with advanced angle-closure glaucoma underwent trabeculectomy.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Eye & ENT Hospital; 🇨🇳 Shanghai, China