Evaluation of Phacogoniotomy in Medically-controlled POAG (ECO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma, Open-Angle; Goniotomy; Cataract Complicated
• Intervention / Treatment: Procedure: PEI+GT; Procedure: PEI+MED

Detailed Description

Glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma (POAG) remaining the most common subtype.

Although there are various methods to treat POAG, medication remains the first choice. However, medication therapy has several limitations, such as multiple adverse effects, poor compliance, and high costs. Therefore, it is imperative to explore treatment modalities that reduce medication burden and improve patients' quality of life.

Minimally invasive glaucoma surgery (MIGS) has been widely employed in clinical practice in recent years and become the mainstream surgical approach for POAG treatment. Among them, various forms of Schlemm's canal-based procedures, which were commonly known as ab interno trabeculotomy or goniotomy (GT) have garnered clinical significance due to their advantages of simplicity, minimal invasiveness, low complication rates, and rapid recovery. These procedures can also be combined with phacoemulsification with intraocular lens implantation (PEI). Currently, several GT techniques have been reported using different devices with different ranges of incision. The investigators have proved that a 120-degree GT with or with PEI were effective enough to treat patients with POAG with or without cataract, providing a comparable efficacy with 240 or 360 degree GT. The 120-degree is characterized by not only its efficacy, but also its fewer complications, faster procedure and quicker recovery. Although the techniques have been implemented clinically, further research is needed to evaluate their economics value in terms of reducing patient dependence on medication, relieving the economic burden of glaucoma medications, and improving the quality of life.

Therefore, a non-inferiority randomized controlled trial (RCT) will be conducted in medically controlled POAG patients with cataract, comparing PEI+GT to PEI combined with medication therapy (PEI+MED). The trial aims to validate the effectiveness of GT in reducing medication use, lightening the burden on patients, and providing a novel treatment approach.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiulan Zhang, MD. PhD; Phone Number: +86 13570166308; Email: zhangxl2@mail.sysu.edu.cn
• Study Contact Backup: Name: Yunhe Song, MD, PhD; Phone Number: +86 13059106657; Email: songyh33@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Xiulan Zhang, MD, PhD; Phone Number: +86 13059106657; Email: zhangxl2@mail.sysu.edu.cn
      • Contact: Yunhe Song, MD, PhD; Phone Number: +86 13059106657; Email: songyh33@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 40 ≤ Age ≤ 85 years, gender unrestricted.
2. Diagnosed with POAG.
3. Controlled IOP under 1 to 4 topical hypotensive medications, IOP ≤ 24 mmHg
4. Mean deviation (MD) for perimetry ≥ -16dB.
5. Presence of clinically significant cataract and best-corrected visual acuity measured using the ETDRS chart ≤ 0.63.
6. Voluntary participation of the patient in this study, signing an informed consent form, and agreeing to follow-up visits according to the study protocol.

Exclusion Criteria:

1. Any history of intraocular surgery or ocular trauma.
2. 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).
3. Presence of severe ocular diseases of various types that affect the acquisition of ocular parameters or interfere with perimetry.
4. Axial length > 28 mm.
5. Monophthalmia (best-corrected visual acuity of the non-study eye < 0.01).
6. Coexistence of severe systemic diseases affecting the entire body.

7. Pregnant or lactating women.

   • If both eyes of a patient meet the criteria, the eye with worse visual acuity will be selected for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEI+GT; Experimental group: Phacoemulsification with intraocular lens implantation (PEI) and goniotomy (GT).	Procedure: PEI+GT; 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).
Active Comparator: PEI+MED; Controll group: Phacoemulsification with intraocular lens implantation (PEI) and medication therapy (MED).	Procedure: PEI+MED; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP at 12 months after surgery.	The intraocular pressure (mmHg) at 12 months after surgery.	Postopertive 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery success of surgery	(i) Complete success (%) is defined as the postoperative 5 < IOP ≤ 16 mmHg with no need for IOP-lowering medication, without any vision-threatening complication or need for re-operation. (ii) Qualified success (%) is defined as the postoperative 5 < IOP ≤ 16 mmHg regardless of IOP-lowering medication, without any vision-threatening complication or need for re-operation.	Postoperative 3, 6, 12 months.
Amount of postoperative anti-glaucomatous medications	The amount of postoperative anti-glaucomatous medications will be measured as: types of medication (No.) × time (No.).	Postoperative 1, 3, 6, 12 months.
Cost-effectiveness associated parameters	Cost-effectiveness associated parameters: cost of surgery and medications; quality-adjusted life year, etc.	Postoperative 12 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery complications	Incidence of surgery complications.	Postoperative 1, 3, 6, 12 months.
Visual acuity	Unit: logMAR	Postoperative 1, 3, 6, 12 months.
Corneal endothelial cell counting	Unit: cells/mm^2	Postoperative 12 months.
Visual field	Mean deviation (MD) and pattern standard deviation (PSD) using Humphrey perimetery	Postoperative 12 months.
Optic nerve head morphology and retinal parameters based on optical coherence tomography	Thickness (μm) of peripapillary retinal nerve fiber layer and macular GC-IPL are collected from optical coherence tomography device.	Postoperative 12 months.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: August 27, 2023
• First Submitted That Met QC Criteria: January 1, 2024
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Cataract; Glaucoma, Open-Angle; Minimally invasive glaucoma surgery; Goniotomy
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Ocular Hypertension; Cataract; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 2023KYPJ268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No