NCT04878458Active, not recruiting
Phacotrabeculectomy Versus Phacogoniotomy (PVP) in Advanced Primary Angle-closure Glaucoma
Effectiveness and Safety of Phacotrabeculectomy and Phacogoniotomy in Advanced Primary Angle-closure Glaucoma: a Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 11 Dec 2024
Brief summary (registry, in English)
A multicenter, parallel, open, non-inferior randomized controlled trial was conducted to compare the effectiveness and safety of phacotrabeculectomy and phacogoniotomy in the treatment of advanced primary angle closure glaucoma, so as to provide a better surgical alternative.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 124 (actual)
- First submitted
- 6 May 2021
- Start date
- 31 May 2021
- Primary completion date
- 30 May 2023
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Glaucoma
- NCT number
- NCT04878458
What you commit to
- Study type: Interventional
- Participants enrolled: 124
- From 31 May 2021 to the primary completion date, 30 May 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Inclusion criteria
- Aged 40-80 years;
- Diagnosed with advanced PACG: meet with (1) (2) (3) or (1) (2) (4)
- At least 180-degree PAS under gonioscopy and it should cover the nasal and inferior quadrants for surgical purposes;
- IOP \>21 mmHg with or without anti-glaucoma medication;
- Obvious glaucomatous optic neuropathy (cup-to-disc \[C/D\] ratio≥0.7, or C/D asymmetry \> 0.2, or the rim width at the superior and inferior temporal \< 0.1 vertical diameters of optic disc);
- With glaucomatous visual field defects, such as nasal step, arcuate scotoma, and paracentral scotoma on a reliable Humphrey analyzer using SITA-Standard 24-2 or 30-2 algorithm; mean deviation ≤ -12dB;
- Clinically obvious cataract and uncorrected visual acuity (UCVA) \<0.63 (Early Treatment Diabetic Retinopathy Study, \[ETDRS\] chart), or need lens extraction assessed by a clinician;
- Voluntarily participate in study and provide signed informed consent.
- Exclusion criteria a. History of ocular surgery (other than laser iridotomy or laser iriplasty) or trauma; b. With other types of glaucoma; (i.e. open angle glaucoma, secondary angle-closure glaucoma, steroidal glaucoma, angle regression glaucoma, neovascular glaucoma, nanophthalmos, pseudoexfoliation syndrome) c. The International Standardized Ratio \> 3.0 for patients receiving warfarin or anticoagulant therapy before surgery; d. With retinal disease that affects the collection of ocular parameters; f. Monophthalmia (best-corrected visual acuity \[BCVA\] \<0.01 in the non-study eye); g. With other serious systemic diseases; h. Pregnant or lactating women \* If both eyes are eligible for the study, the eye with the worse UCVA will be recruited.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Ophthalmic Center Coordinator of this site? Confirm its status | Guangdong | China | Unknown status |
| Zhongshan Ophthalmic Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.