Biometric Changes After Intervention of Anterior Chamber Angle : an Observational Study

NCT06492538 | Recruiting

• 1 other identifier: 2023KYPJ304
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The drainage angle in the anterior chamber of the eye mediates the outflow of aqueous humor, and pathological changes here can lead to high intraocular pressure and glaucoma. Minimally invasive glaucoma surgery, particularly angle surgery, has advanced recently, allowing clear visualization of angle structures like the trabecular meshwork and Schlemm's canal using surgical goniolens. Techniques for angle intervention include widening the angle, reopening closed angles, and rebuilding outflow pathways using methods such as laser peripheral iridotomy, Argon laser peripheral iridoplasty, and mechanical separation of adhered tissues. Our research team plans to conduct imaging studies to track the healing of angle tissues post-surgery, aiming to support innovation and standardization of minimally invasive angle surgery.

Conditions

Minimally Invasive Glaucoma Surgery; Goniosynechialysis; Goniotomy; Glaucoma; Angle-closure Glaucoma

Outcome Measures

Primary Outcomes (1)

• Changes in biological parameters of the anterior chamber angle

  Biological parameter changes in the anterior chamber following angle intervention surgery will be measured using Casia2-OCT

  12 months

Secondary Outcomes (1)

• success rate of angle intervention surgeries

  12 months

Other Outcomes (1)

• safety of angle intervention surgeries

  1 months

Study Arms (5)

laser peripheral iridotomy/iridoplasty group

based on angle closure mechanism, procedures were chosen LPI alone or combined with ALPIp. LPI: laser peripheral iridotomy; ALPIp: argon laser peripheral iridoplasty.

Procedure: various types of angle interventions

peripheral iridectomy based surgery combo

SPI combined with GSL or GSL+GT SPI: surgical peripheral iridectomy GSL:goniosynechialysis GT: goniotomy GSL and GT are both guided by surgical goniolens

Procedure: various types of angle interventions

phacoemulsification and intraocular lens implantation based surgery combo

PEI: phacoemulsification and intraocular lens implantation surgery combo includes GSL alone or GSL+GT.

Procedure: various types of angle interventions

ab interno goniotomy

GT was performed in the nasal-inferior quadrant or nasal quadrant because the collector channels were mainly concentrated in the nasal quadrant, by inserting the tip of a microblade (TMH; Tanito Microhook, Inami \& Co., Ltd., Tokyo, Japan) into Schlemm's canal, and then the inner wall of Schlemm's canal and trabecular meshwork was incised over 120°

Procedure: various types of angle interventions

Schlemm canaloplasty

performed in the nasal quadrant by the collector channels were mainly concentrated in the nasal quadrant, by inserting the tip of a microblade (TMH; Tanito Microhook, Inami \& Co., Ltd., Tokyo, Japan) into Schlemm's canal, and then the inner wall of Schlemm's canal and trabecular meshwork was incised over 120°

Procedure: various types of angle interventions

Interventions

various types of angle interventions PROCEDURE

procedures include laser peripheral iridotomy (LPI) to relieve pupillary tissue and deepen peripheral anterior chamber depth, Argon laser peripheral iridoplasty (ALPIp) to stimulate iris contraction and widen the angle, and mechanical separation of adhered angle tissues using instruments like goniosynechialysis hooks or iris repositor. Ab interno goniotomy using instruments like retina hooks, trabeculectomy hooks, or cannulas are used to incise trabecular meshwork and Schlemm's canal walls to enhance aqueous humor outflow.

Schlemm canaloplasty; ab interno goniotomy; laser peripheral iridotomy/iridoplasty group; peripheral iridectomy based surgery combo; phacoemulsification and intraocular lens implantation based surgery combo

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with glaucoma typically present with: IOP \> 21 mmHg with or without the use of ocular hypotensive medications; (3) with obvious glaucomatous optic neuropathy \[cup-to-disc (C/D) ratio ≥ 0.7, C/D ratio asymmetry \> 0.2, or rim width at the superotemporal and inferotemporal \< 0.1 vertical diameter of the optic disc\], and glaucomatous visual field defects, such as nasal step, arcuate scotoma, and paracentral scotoma;

You may qualify if:

• Glaucoma patients eligible for standalone or combined angle intervention surgeries, such as LPI, LPIP, goniosynechialysis, trabeculotomy alone or combined with surgical iridectomy or phacoemulsification and intraocular lens implantation;
• Patients capable of undergoing preoperative examinations including CASIA2-OCT (anterior segment OCT), UBM, slit-lamp gonioscopy, IOL Master (or other optical biometry);
• Patients willing to participate in this study, signing informed consent, and agreeing to follow-up according to the study protocol.

You may not qualify if:

• Patients with severe ocular conditions such as corneal infection, ulcer, trauma, ocular tumors, retinal vascular occlusion, and retinal detachment;
• Those with various types of eye diseases that affect ocular parameter acquisition or interfere with visual field examination;
• Long-term local or systemic use of glucocorticoids;
• Patients with severe systemic diseases;
• Pregnant or lactating women;
• Unable to complete 12-month postoperative follow-up.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan ophthalmic center

Guangzhou, Guangdong, 51006dddddd0, China

RECRUITING

MeSH Terms

Conditions

Glaucoma, Angle-Closure; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Xinbo Gao, MD

  State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinbo Gao, MD

CONTACT

+8618319579657; gaoxb@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: December 1, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-10

Locations

CN (1)