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NCT Number: NCT07821827

Combined Phacoemulsification-Goniotomy in Primary Open-Angle and Primary Angle-Closure Glaucoma

This study evaluates whether combining cataract surgery (phacoemulsification) with incisional goniotomy effectively lowers intraocular pressure (IOP) and reduces the need for glaucoma medications in patients with coexisting cataract and glaucoma.

Conventional filtering surgeries, such as trabeculectomy, effectively reduce eye pressure but are often associated with bleb-related complications, hypotony, and intensive postoperative management. Goniotomy is an angle-based, conjunctival-sparing procedure that enhances natural aqueous outflow by incising the trabecular meshwork. When performed alongside phacoemulsification, cataract removal deepens the anterior chamber while goniotomy addresses outflow resistance without disrupting conjunctival tissue.

The main goal of this study is to compare the efficacy and safety profile of combined phacoemulsification and goniotomy between two distinct glaucoma phenotypes: primary open-angle glaucoma (POAG) and primary angle-closure glaucoma (PACG).

Participants will:

* Undergo standard clear corneal phacoemulsification with intraocular lens (IOL) implantation combined with nasal incisional goniotomy under direct gonioscopic visualization. * Complete postoperative follow-up examinations at Day 1, Week 1, and Months 1, 3, 6, 9, and 12. * Be monitored for changes in intraocular pressure, total number of glaucoma medications required, visual acuity, and postoperative complications for a minimum duration of 6 months.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 40 years and older (no upper limit).
  • Diagnosis of uncontrolled or progressive primary open-angle glaucoma (POAG) or primary angle-closure glaucoma (PACG).
  • Presence of visually significant cataract requiring phacoemulsification.
  • Willingness and ability to complete the postoperative follow-up schedule of at least 6 months.

Exclusion criteria

  • Secondary glaucoma.
  • Prior incisional glaucoma surgery or selective laser trabeculoplasty (SLT) in the study eye.
  • Corneal opacity preventing adequate gonioscopic visualization of the angle.
  • Associated retinal disease or non-glaucomatous optic nerve disease.
  • Inability or unwillingness to adhere to the follow-up schedule.

Treatment and study plan

Combined Phacoemulsification and Goniotomy

Procedure

Standard temporal clear corneal phacoemulsification (2.2-2.4 mm incision) with foldable acrylic intraocular lens (IOL) implantation into the capsular bag under local anesthesia. Following IOL placement and anterior chamber reformation with cohesive viscoelastic, the patient's head is rotated 35°-40° and the surgical microscope tilted 30°-40°. Under direct visualization using a Swan-Jacob goniolens, an ab-interno nasal incisional goniotomy spanning approximately 120°-140° of the trabecular meshwork is performed through the main corneal incision using a 20G MVR blade or 27G needle tip. Viscoelastic is then completely aspirated, wound integrity is confirmed, and intracameral antibiotic may be administered.

Primary outcomes

  1. Change in Intraocular Pressure

    Time frame: Baseline and 6 months postoperatively

    Intraocular pressure is measured in millimeters of mercury (mmHg) using Goldmann applanation tonometry. Values represent the change in IOP calculated as post-intervention IOP minus baseline IOP.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Combined Phacoemulsification-Goniotomy in Primary Open-Angle and Primary Angle-Closure Glaucoma: A Comparative Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2026
Registry last updated
Sep 16, 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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