Clinical trial NCT04703712: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma, Angle-Closure
Keywords: phacoemulsification
goniosynechialysis
trabeculectomy
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 316
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraocular pressure (IOP) change at one month
timeFrame: one month
measure: IOP change at three months
timeFrame: three months
measure: IOP change at six months
timeFrame: six months
measure: IOP change at one year
timeFrame: one year
measure: IOP change at two years
timeFrame: two years
measure: IOP change at three years
timeFrame: three years
measure: Best corrected visual acuity at one month
timeFrame: one month
measure: Best corrected visual acuity at three months
timeFrame: three months
measure: Best corrected visual acuity at six months
timeFrame: six months
measure: Best corrected visual acuity at one year
timeFrame: one year
measure: Best corrected visual acuity at two years
timeFrame: two years
measure: Best corrected visual acuity at three years
timeFrame: three years
Secondary outcomes:
measure: Mean deviation
timeFrame: one month, three months, six months, one year, two years, three years
measure: The thickness of retinal nerve fiber layer (RNFL)
timeFrame: one month, three months, six months, one year, two years, three years
measure: The thickness of ganglion cell complex (GCC)
timeFrame: one month, three months, six months, one year, two years, three years
measure: Number of eye drops
timeFrame: one month, three months, six months, one year, two years, three years
measure: Adverse event
timeFrame: one month, three months, six months, one year, two years, three years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & ENT Hospital
Study officials:
References: