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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Combined Phacoemulsification and Goniotomy

    Procedure/Surgery

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: POAG Group (Phaco-Goniotomy)Experimental treatment 1 intervention
Group B: PACG Group (Phaco-Goniotomy)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Intraocular Pressure

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.

Time frame
Baseline and 6 months postoperatively

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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