Primary Open-Angle GlaucomaNCT07821827
Combined Phacoemulsification-Goniotomy in Primary Open-Angle and Primary Angle-Closure Glaucoma
A study testing Combined Phacoemulsification and Goniotomy in people with Primary Open-Angle Glaucoma and Primary Angle-Closure Glaucoma, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Primary Open-Angle Glaucoma, Primary Angle-Closure Glaucoma, Cataract
- What is being tested?
- Combined Phacoemulsification and Goniotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Combined Phacoemulsification-Goniotomy in Primary Open-Angle and Primary Angle-Closure Glaucoma: A Comparative Study
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.
Read more
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.
- Being tested
- Combined Phacoemulsification and Goniotomy
- Keywords
- Goniotomy, Phacoemulsification, Phacogoniotomy, Intraocular Pressure, Minimally Invasive Glaucoma Surgery, Angle Surgery, POAG, PACG
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma, Angle-Closure, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Phacoemulsification and GoniotomyProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| POAG Group (Phaco-Goniotomy) | Experimental | Patients with uncontrolled or progressive primary open-angle glaucoma (POAG) and coexisting cataract undergoing clear corneal phacoemulsification with intraocular lens (IOL) implantation combined with ab-interno nasal incisional goniotomy (120°-140°) using a 20G MVR blade or 27G needle under direct Swan-Jacob goniolens visualization. Receives: Procedure: Combined Phacoemulsification and Goniotomy |
| PACG Group (Phaco-Goniotomy) | Experimental | Patients with uncontrolled or progressive primary angle-closure glaucoma (PACG) and coexisting cataract undergoing clear corneal phacoemulsification with intraocular lens (IOL) implantation combined with ab-interno nasal incisional goniotomy (120°-140°) using a 20G MVR blade or 27G needle under direct Swan-Jacob goniolens visualization. Receives: Procedure: Combined Phacoemulsification and Goniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open-Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelnaser Mohamed Abdelnaser, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821827
- Sponsor's protocol ID
- Phaco-Goniotomy: POAG vs. PACG
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Phacoemulsification-Goniotomy in Primary Open-Angle and Primary Angle-Closure Glaucoma: A Comparative Study
- ClinicalTrials.gov ID
- NCT07821827
- Acronym / sponsor ID
- Phaco-Goniotomy: POAG vs. PACG
- Keywords
- Goniotomy, Phacoemulsification, Phacogoniotomy, Intraocular Pressure, Minimally Invasive Glaucoma Surgery, Angle Surgery, POAG, PACG
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POAG Group (Phaco-Goniotomy) | Experimental | Procedure: Combined Phacoemulsification and GoniotomyPatients with uncontrolled or progressive primary open-angle glaucoma (POAG) and coexisting cataract undergoing clear corneal phacoemulsification with intraocular lens (IOL) implantation combined with ab-interno nasal incisional goniotomy (120°-140°) using a 20G MVR blade or 27G needle under direct Swan-Jacob goniolens visualization. |
| PACG Group (Phaco-Goniotomy) | Experimental | Procedure: Combined Phacoemulsification and GoniotomyPatients with uncontrolled or progressive primary angle-closure glaucoma (PACG) and coexisting cataract undergoing clear corneal phacoemulsification with intraocular lens (IOL) implantation combined with ab-interno nasal incisional goniotomy (120°-140°) using a 20G MVR blade or 27G needle under direct Swan-Jacob goniolens visualization. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Phacoemulsification and GoniotomyStandard 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. | Procedure or surgery | PACG Group (Phaco-Goniotomy), POAG Group (Phaco-Goniotomy) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Phacoemulsification and Goniotomy in people with Primary Open-Angle Glaucoma and Primary Angle-Closure Glaucoma, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intraocular Pressure (time frame: Baseline and 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.