Evaluation of Phacogoniotomy in Medically-controlled POAG

NCT06201455 | Recruiting DMC

• 1 other identifier: 2023KYPJ268
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma, Open-Angle; Cataract Complicated; Goniotomy

Keywords

Glaucoma, Open-Angle; Cataract; Goniotomy; Minimally invasive glaucoma surgery

Outcome Measures

Primary Outcomes (1)

• IOP at 12 months after surgery.

  The intraocular pressure (mmHg) at 12 months after surgery.

  Postopertive 12 months.

Secondary Outcomes (3)

• Surgery success of surgery

  Postoperative 3, 6, 12 months.

• Amount of postoperative anti-glaucomatous medications

  Postoperative 1, 3, 6, 12 months.

• Cost-effectiveness associated parameters

  Postoperative 12 months.

Other Outcomes (5)

• Surgery complications

  Postoperative 1, 3, 6, 12 months.

• Visual acuity

  Postoperative 1, 3, 6, 12 months.

• Corneal endothelial cell counting

  Postoperative 12 months.

Study Arms (2)

PEI+GT

EXPERIMENTAL

Experimental group: Phacoemulsification with intraocular lens implantation (PEI) and goniotomy (GT).

Procedure: PEI+GT

PEI+MED

ACTIVE COMPARATOR

Controll group: Phacoemulsification with intraocular lens implantation (PEI) and medication therapy (MED).

Procedure: PEI+MED

Interventions

PEI+GT PROCEDURE

After a standard phacoemulsification with intraocular lens implantation (PEI) is performed. The viscoelastic substance will be injected into the anterior chamber again to maintain corneal rigidity. The surgical microscope will be adjusted to tilt 35-40° towards the patient's nasal side, and the patient's head position will be adjusted to tilt 35-40° accordingly. A viscoelastic substance will be applied to the corneal surface to facilitate direct visualization of the angle structures under a gonioscope. The Tanito Microhook will be inserted through the main incision into the anterior chamber, and under gonioscopic guidance, the nasal (or inferonasal) trabecular meshwork and the inner wall of Schlemm's canal will be incised, approximately 120° in extent (60° in each direction).

PEI+GT

PEI+MED PROCEDURE

Participants assigned to control group will undergo routine PEI surgery. Postoperatively, the decision to administer anti-glaucoma medication is based on intraocular pressure (IOP) measurements, and the target IOP is set at 16 mmHg. The selection of medications is informed by the Asia Pacific Glaucoma Guidelines (Kugler Publications, 2016), while the target IOP reference is the European Glaucoma Guidelines.

PEI+MED

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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.

You may not qualify if:

• Any history of intraocular surgery or ocular trauma.
• Presence of other types of glaucoma, including primary angle-closure glaucoma and various forms of secondary glaucoma (e.g. secondary angle-closure, pigmentary, steroid-induced, angle-recession, neovascular, inflammatory, and pseudoexfoliation syndrome).
• Presence of severe ocular diseases of various types that affect the acquisition of ocular parameters or interfere with perimetry.
• Axial length \> 28 mm.
• Monophthalmia (best-corrected visual acuity of the non-study eye \< 0.01).
• Coexistence of severe systemic diseases affecting the entire body.
• Pregnant or lactating women.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• West China Hospital: collaborator
• Chongqing Medical University: collaborator
• The Second Hospital of Anhui Medical University: collaborator
• Handan City Eye Hospital: collaborator
• Shijiazhuang People's Hospital: collaborator
• Chengdu First People's Hospital: collaborator
• Guangdong Hospital of Traditional Chinese Medicine, Zhuhai: collaborator
• Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong: collaborator
• Huizhou Municipal Central Hospital: collaborator

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Capsule Opacification; Cataract

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Lens Diseases

Central Study Contacts

Xiulan Zhang, MD. PhD

CONTACT

+86 13570166308; zhangxl2@mail.sysu.edu.cn

Yunhe Song, MD, PhD

CONTACT

+86 13059106657; songyh33@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: January 11, 2024
• Study Start: September 28, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

CN (1)