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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-85
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial 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;

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • various types of angle interventions

    Procedure/Surgery

    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.

Treatment groups

300 Participants
are divided into 5 treatment groups
Group A: laser peripheral iridotomy/iridoplasty group1 intervention
Group B: peripheral iridectomy based surgery combo1 intervention
Group C: phacoemulsification and intraocular lens implantation based surgery combo1 intervention
Group D: ab interno goniotomy1 intervention
Group E: Schlemm canaloplasty1 intervention

Trial outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.