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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07821827
Enrollment
70
Registered
2026-09-16
Start date
2026-10-01
Completion date
2027-11-01
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Primary Angle-Closure Glaucoma, Primary Open-Angle Glaucoma

Keywords

Goniotomy, Phacoemulsification, Phacogoniotomy, Intraocular Pressure, Minimally Invasive Glaucoma Surgery, Angle Surgery, POAG, PACG

Brief summary

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.

Interventions

PROCEDURECombined Phacoemulsification and Goniotomy

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Intraocular PressureBaseline and 6 months postoperativelyIntraocular 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026