Efficacy of Phacogoniotomy in Medically-controlled Primary Open-angle Glaucoma With Cataract a Multicenter Non-inferiority Randomized Controlled Trial

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

The goal of this multicenter non-inferiority randomized controlled trial is to compare the efficacy of phacoemulsification with intraocular lens implantation (PEI) combined with goniotomy (GT) and PEI combined with medical therapy (MED) in the treatment of medically-controlled primary open-angle glaucoma (POAG) with cataract. The main questions it aims to answer are: * Whether the PEI+GT was non-inferior to PEI+MED with regard to the intraocular pressure lowering effect in medically-controlled POAG. * Whether the PEI+GT has value of health economics. Participants will be randomized to receive either PEI+GT or PEI+MED, and followed up with a 1-year period as a primary outcome.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:

• 40 ≤ Age ≤ 85 years, gender unrestricted.

• Diagnosed with POAG.

• Controlled IOP under 1 to 4 topical hypotensive medications, IOP ≤ 24 mmHg

• Mean deviation (MD) for perimetry ≥ -16dB.

• Presence of clinically significant cataract and best-corrected visual acuity measured using the ETDRS chart ≤ 0.63.

• Voluntary participation of the patient in this study, signing an informed consent form, and agreeing to follow-up visits according to the study protocol.

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
Yunhe Song, MD, PhD
songyh33@mail.sysu.edu.cn
+86 13059106657
Time Frame
Start Date: 2023-09-28
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 100
Treatments
Experimental: PEI+GT
Experimental group: Phacoemulsification with intraocular lens implantation (PEI) and goniotomy (GT).
Active_comparator: PEI+MED
Controll group: Phacoemulsification with intraocular lens implantation (PEI) and medication therapy (MED).
Sponsors
Collaborators: Huizhou Municipal Central Hospital, Chongqing Medical University, Guangdong Hospital of Traditional Chinese Medicine, Zhuhai, The Second Hospital of Anhui Medical University, Shijiazhuang People's Hospital, West China Hospital, Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong, Handan City Eye Hospital, Chengdu First People's Hospital
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov