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RecruitingNCT06492538Updated Dec 12, 2025

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

An observational study in Angle-closure Glaucoma, Minimally Invasive Glaucoma Surgery and Goniosynechialysis, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-12-12.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Dec 2023; still recruiting 2 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
30 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description

Pathological elevated intraocular pressure is one of the most important disease characteristics of glaucoma. Blockage of aqueous humor outflow within the eye is the primary cause of high intraocular pressure. The drainage angle in the anterior chamber of the eye mediates the outflow of aqueous humor. Pathological changes in this area can lead to the development of high intraocular pressure and glaucoma, such as primary angle closure glaucoma (PACG) caused by angle closure. Minimally invasive glaucoma surgery has rapidly developed in recent years, with angle surgery being a major branch. With the use of surgical goniolens, structures within the angle, such as trabecular meshwork and Schlemm's canal, can be visualized clearly during surgery. Methods for angle intervention include but not limit ed to widening the peripheral anterior chamber angle, reopening adhered or appositionally closed angles, and rebuilt outflow pathways by incising diseased areas to increase aqueous humor outflow. Techniques include laser peripheral iridotomy (LPI) to relieve pupillary block and deepen the peripheral anterior chamber, 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 repositors. Surgical incision using instruments such as Microhook, trabeculectomy hooks, or cannulas can be performed to remove the diseased inner wall of Schlemm's canal and the diseased trabecular meshwork either partially or circumferentially. However, the healing and outcomes of angle tissues following invasive angle interventions, and their impact on surgical outcomes, remain unclear. Therefore, our research team proposes to conduct imaging observation studies to track, observe, and quantify the status of the angle, exploring the healing process of angle tissues. This aims to provide theoretical support for the innovation and standardization of minimally invasive angle surgery.

02

Conditions studied

  • Angle-closure Glaucoma
  • Minimally Invasive Glaucoma Surgery
  • Goniosynechialysis
  • Goniotomy
  • Glaucoma
03

In context

Glaucoma, Angle-Closure

91 studies on the registry are indexed under Glaucoma, Angle-Closure; 17 are open to participants now.

This study's planned enrollment of 300 is above the median of 225 across 32 observational studies indexed under Glaucoma, Angle-Closure.

Browse Glaucoma, Angle-Closure studies →

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 85 Years
Sexes eligible
All
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;

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 , and agreeing to follow-up according to the study protocol.

Exclusion criteria

Exclusion Criteria:

  • 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 ;
  • Patients with severe systemic diseases;
  • Pregnant or lactating women;
  • Unable to complete 12-month postoperative follow-up.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Procedurevarious types of angle interventions

    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.

06

What researchers measure

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

    Time frame: 12 months

Secondary outcomes

  1. success rate of angle intervention surgeries

    complete success was defined as postoperative IOP within the range of 6-18 mmHg, and a reduction of 20% from baseline without loss of light perception, additional ocular hypotensive medication, and reoperation. The definition of qualified success was similar to that of complete success, except for the need for ocular hypotensive medications. Postoperative ocular hypotensive medications were adjusted according to the IOP at each visit.

    Time frame: 12 months

Other outcomes

  1. safety of angle intervention surgeries

    The main observation includes recording intraoperative and postoperative complications, including hyphema, choroidal detachment, cyclodialysis, persistent hypotony, corneal decompensation, and intraocular inflammation.

    Time frame: 1 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06492538
Responsible party
Xinbo Gao (associate professor, Zhongshan Ophthalmic Center, Sun Yat-sen University) — Principal investigator
First posted
Jul 9, 2024
Start date
Dec 1, 2023
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Dec 12, 2025

Study contacts

Xinbo Gao, MD
Contact
gaoxb@mail.sysu.edu.cn
+8618319579657
Xinbo Gao, MD
principal investigator · State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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