Combined Phacoemulsification-Goniotomy in Primary Open-Angle and Primary Angle-Closure Glaucoma
10. september 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
70
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Intraocular Pressure
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
1. oktober 2027
Studiet fullført (Antatt)
1. november 2027
Datoer for studieregistrering
Først innsendt
10. september 2026
Først innsendt som oppfylte QC-kriteriene
10. september 2026
Først lagt ut (Faktiske)
16. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Phaco-Goniotomy: POAG vs. PACG
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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