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NCT Number: NCT06492538

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

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.

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Key information

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan ophthalmic center

Guangzhou, Guangdong, 51006dddddd0, China

Location status: Recruiting

Location contact

Xinbo Gao, MD

CONTACT

[email protected]

+8618319579657

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

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 glucocorticoids;
  • Patients with severe systemic diseases;
  • Pregnant or lactating women;
  • Unable to complete 12-month postoperative follow-up.

Treatment and study plan

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.

Primary outcomes

  1. Changes in biological parameters of the anterior chamber angle

    Time frame: 12 months

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

Secondary outcomes

  1. success rate of angle intervention surgeries

    Time frame: 12 months

    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.

Other outcomes

  1. safety of angle intervention surgeries

    Time frame: 1 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xinbo Gao, MD

CONTACT

[email protected]

+8618319579657

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2024
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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