Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy

Glaucoma, Angle-Closure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04703712
• Other study ID #: AAC Glaucoma
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2021
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Eye & ENT Hospital of Fudan University
• Contact: Feng Gao, Doctor
• Phone: (86)021-64377134
• Email: fenggao[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 316
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Angle-Closure

Intervention

Procedure:
• Lens extraction combined with goniosynechialysis
The patients enrolled underwent phacoemulsification combined with goniosynechialysis surgery.
• Trabeculectomy surgery
The patients enrolled underwent trabeculectomy surgery

Locations

Country	Name	City	State
China	Eye & ENT Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure (IOP) change at one month	Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one month.	one month
Primary	IOP change at three months	Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three months.	three months
Primary	IOP change at six months	Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at six months.	six months
Primary	IOP change at one year	Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one year.	one year
Primary	IOP change at two years	Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at two years.	two years
Primary	IOP change at three years	Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three years.	three years
Primary	Best corrected visual acuity at one month	Best corrected visual acuity of participants after surgery at one month	one month
Primary	Best corrected visual acuity at three months	Best corrected visual acuity of participants after surgery at three months	three months
Primary	Best corrected visual acuity at six months	Best corrected visual acuity of participants after surgery at six months	six months
Primary	Best corrected visual acuity at one year	Best corrected visual acuity of participants after surgery at one year	one year
Primary	Best corrected visual acuity at two years	Best corrected visual acuity of participants after surgery at two years	two years
Primary	Best corrected visual acuity at three years	Best corrected visual acuity of participants after surgery at three years	three years
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of eye drops	The number of eye drops after surgery.	one month, three months, six months, one year, two years, three years
Secondary	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