Combined Phacoemulsification-Goniotomy in Primary Open-Angle and Primary Angle-Closure Glaucoma
10 september 2026 uppdaterad av: Ahmed Abdelnaser Mohamed Abdelnaser, Assiut University
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.
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.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
70
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: POAG Group (Phaco-Goniotomy)
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.
|
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.
|
|
Experimentell: PACG Group (Phaco-Goniotomy)
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Intraocular Pressure
Tidsram: 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.
|
Baseline and 6 months postoperatively
|
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 oktober 2026
Primärt slutförande (Beräknad)
1 oktober 2027
Avslutad studie (Beräknad)
1 november 2027
Studieregistreringsdatum
Först inskickad
10 september 2026
Först inskickad som uppfyllde QC-kriterierna
10 september 2026
Första postat (Faktisk)
16 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Phaco-Goniotomy: POAG vs. PACG
Läkemedels- och apparatinformation, studiedokument
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