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Not yet recruiting NCT07549438

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

Observational Primary Angle-Closure Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Primary Angle-Closure Glaucoma. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Incidence of Ciliary Block (Classic and Partial) [Time frame: Up to 12 months postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07549438 · PekingUPHOphthalmology004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗