Effectiveness and Safety of Trabeculectomy and Peripheral Iridectomy Plus Goniotomy in Advanced Primary Angle-closure Glaucoma: a Multicenter Non-inferiority Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A multicenter, parallel, open, non-inferior randomized controlled trial is conducted to compare the effectiveness and safety of trabeculectomy and peripheral iridectomy plus goniotomy (TVG) in the treatment of advanced primary angle closure glaucoma with no or mild cataracts.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 80
Healthy Volunteers: f
View:

• Age 45-80 years.

• Eyes diagnosed with advanced PACG who meet following criteria a, b, and c; or a, b, and d:

‣ PAS: ≥180° range, including nasal and inferior quadrants;

⁃ IOP \>21 mmHg with or without anti-glaucoma medications (the medications include the maximally tolerated medications), taken with the Goldmann applanation tonometer;

⁃ Glaucomatous optic neuropathy (cup-to-disc \[C/D\] ratio ≥0.7, C/D asymmetry \>0.2, or rim width at the superior and inferior temporal areas \<0.1 of the vertical diameters of the optic disc);

⁃ Glaucomatous visual field defects (nasal step, arcuate scotoma, and paracentral scotoma on a reliable Humphrey analyzer and a mean deviation of ≤-12 dB).

• No or mild cataracts and uncorrected visual acuity of ≥0.63 (Early Treatment Diabetic Retinopathy Study chart);

• Axial length of ≥20 mm.

Locations
Other Locations
China
Zhongshan Ophthalmic Center, Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Xiulan Zhang, MD. PhD
zhangxl2@mail.sysu.edu.cn
+86 13570166308
Backup
Xinbo Gao, MD. PhD
gaoxb@mail.sysu.edu.cn
+86 18319579657
Time Frame
Start Date: 2022-01-05
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 88
Treatments
Active_comparator: Trabeculectomy
Forty-four patients with advanced primary angle closure glaucoma will receive trabeculectomy.
Experimental: SPI+GSL+GT
Forty-four patients with advanced primary angle closure glaucoma will receive surgical peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT).
Sponsors
Collaborators: First Hospital of Shijiazhuang City, Chongqing Medical University, People's Hospital of Chongqing, West China Hospital, The Second Affiliated Hospital of Harbin Medical University, Handan City Eye Hospital
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov