Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy

NCT04703712 | Unknown DMC

• 1 other identifier: AAC Glaucoma
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma, Angle-Closure

Keywords

phacoemulsification; goniosynechialysis; trabeculectomy

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (5)

• Mean deviation

  one month, three months, six months, one year, two years, three years

• The thickness of retinal nerve fiber layer (RNFL)

  one month, three months, six months, one year, two years, three years

• The thickness of ganglion cell complex (GCC)

  one month, three months, six months, one year, two years, three years

• Number of eye drops

  one month, three months, six months, one year, two years, three years

• Adverse event

  one month, three months, six months, one year, two years, three years

Study Arms (2)

Lens extraction combined with goniosynechialysis group

ACTIVE COMPARATOR

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

Procedure: Lens extraction combined with goniosynechialysis

Trabeculectomy Group

ACTIVE COMPARATOR

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

Procedure: Trabeculectomy surgery

Interventions

Lens extraction combined with goniosynechialysis PROCEDURE

The patients enrolled underwent phacoemulsification combined with goniosynechialysis surgery.

Lens extraction combined with goniosynechialysis group

Trabeculectomy surgery PROCEDURE

The patients enrolled underwent trabeculectomy surgery

Trabeculectomy Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye & ENT Hospital

Shanghai, 200031, China

RECRUITING

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Central Study Contacts

Feng Gao, Doctor

CONTACT

(86)021-64377134; fenggao@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: January 11, 2021
• Study Start: January 30, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

CN (1)