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NCT Number: NCT07549438

Predicting the Risk of Partial Ciliary Block After Cataract and Goniosynechialysis Surgery in Primary Angle-Closure Disease

Primary angle-closure disease (PACD) is a major cause of vision loss, often treated with a combined surgery that removes the eye's natural lens (cataract surgery) and physically opens the eye's drainage system (goniosynechialysis). While effective, this surgery carries a small risk of a severe complication called ciliary block (or aqueous misdirection), where fluid builds up in the wrong part of the eye, pushing structures forward and causing high eye pressure. Recently, doctors have also noticed a "partial" form of this block, which can slowly cause the eye's drainage angle to close again without immediate severe symptoms.

The purpose of this prospective, observational study is to identify which patients are at the highest risk for developing classic or partial ciliary block after this combined surgery. Researchers will use standard, non-invasive eye imaging tools-such as ultrasound biomicroscopy (UBM) and optical coherence tomography (OCT)-to take highly detailed measurements of the front of the eye before surgery. They will specifically look at factors like the width of the anterior chamber, the thickness of the lens, and the eye's overall length. To ensure accuracy, patients with a very short eye length (less than 19mm) will not be included in the study.

Because this is an observational study, participation will not change a patient's standard surgical plan. Patients will undergo their scheduled surgery and be monitored for 12 months during routine follow-up visits to track their eye pressure, vision, and any structural changes in the eye.

By confirming which pre-surgery measurements predict ciliary block, researchers hope to validate a risk-warning model. This will help eye surgeons take preventive steps-such as administering specific medications like mannitol before surgery-to make the procedure safer and improve long-term outcomes for patients with PACD.

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Key information

Sex eligibility

All sexes

Study type

Observational

Who can participate

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

Inclusion criteria

  • Diagnosis of Primary Angle-Closure Disease (PACD), including Primary Angle-Closure Suspect (PACS), Primary Angle-Closure (PAC), or Primary Angle-Closure Glaucoma (PACG).
  • Clinical indication for phacoemulsification combined with intraocular lens implantation and goniosynechialysis (Phaco+GSL), due to poorly controlled intraocular pressure, extensive peripheral anterior synechiae (PAS), or the presence of a clinically significant cataract.
  • Ability to cooperate with required preoperative imaging examinations, including Ultrasound Biomicroscopy (UBM), IOLMaster, and Anterior Segment Optical Coherence Tomography (AS-OCT).

Exclusion criteria

  • Secondary angle closure (e.g., neovascular glaucoma, uveitic glaucoma, iridocorneal endothelial [ICE] syndrome, or intraocular tumors/cysts).
  • Specific lens abnormalities that confound anatomical assessment, including lens subluxation, hypermature intumescent cataract, or traumatic cataract.
  • Previous intraocular surgery, including glaucoma filtering surgeries (e.g., trabeculectomy, tube shunts) or vitreoretinal surgeries (Note: Previous laser peripheral iridotomy is permitted).
  • Use of systemic or topical medications known to affect ciliary body morphology or pupillary function (e.g., topiramate, cholinergic agonists) during the time of imaging.
  • Poor quality or uninterpretable preoperative UBM or OCT images due to corneal opacity, edema, or other media opacities.
  • Axial length shorter than 19mm.

Treatment and study plan

Primary outcomes

  1. Incidence of Ciliary Block (Classic and Partial)

    Time frame: Up to 12 months postoperatively

    The primary outcome is the occurrence rate of classic or partial ciliary block (CB) following phacoemulsification combined with goniosynechialysis. Classic CB is diagnosed by a shallow or flat anterior chamber with elevated intraocular pressure, excluding pupillary block or choroidal effusion. Partial (subclinical) CB is defined by meeting at least two of the following criteria: an unexpected shallow anterior chamber (e.g., less than the expected 3mm or significantly smaller than the contralateral eye), a significant myopic shift (≥ -1.50D) indicating IOL-iris diaphragm anterior shift, UBM/OCT evidence of ciliary body anterior rotation, or significant deepening of the anterior chamber after cycloplegic administration. Intraoperative aqueous misdirection is also recorded as a primary endpoint event.

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

Risk Prediction of Partial Ciliary Block After Phacoemulsification Combined With Goniosynechialysis in Primary Angle-Closure Disease: A Prospective Multicenter Study

Acronym: PCB-Risk

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

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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