Status:
UNKNOWN
eyeWatch vs. Trabeculectomy RCT (evT)
Lead Sponsor:
Dr. Kaweh Mansouri
Collaborating Sponsors:
Manchester Royal Eye Hospital
Conditions:
Primary Glaucoma
Eligibility:
All Genders
18-95 years
Phase:
NA
Brief Summary
The confirm the performance and safety of the eyeWatch System as first-line filtering surgery and compare its outcomes to trabeculectomy
Detailed Description
Open-angle glaucoma is an ophthalmic disease often characterised by high intraocular pressures. Traditionally, glaucoma is treated using medication, however, more advanced or refractory glaucoma requi...
Eligibility Criteria
Inclusion
- Aged between 18 and 95 years,
- Diagnosis of primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma in the study eye (based on \[1\] glaucomatous optic neuropathy and \[2\] visual field defects in keeping with optic disc appearance),
- Phakic or pseudophakic study eye,
- Indication for primary filtering surgery (defined as a corrected IOP ≥ 20 mmHg in the study eye, under maximally tolerated therapy on 2 consecutive measurements made on different days prior to surgery),
- Undergoing surgery and post-operative follow-up at one of the investigations centres: Montchoisi Clinic, Swiss Visio, Lausanne, Switzerland OR Manchester Royal Eye Hospital, Manchester, United-Kingdom,
- Patient agreed to sign the written inform consent prior to entering the study,
- Patient is able and willing to complete post-operative follow-up requirements.
Exclusion
- Diagnosis of secondary glaucoma except for pseudo-exfoliative or pigmentary glaucoma (neovascular glaucoma, congenital glaucoma, uveitic glaucoma…),
- Previous filtering or tube surgery in the same eye (including trabeculectomy, deep-sclerectomy and all GDDs / excluding XEN gel stents, angle surgery, cataract surgery and all MIGS),
- Recent ophthalmic surgery (less than 3 months prior to inclusion) or indication for a combined procedure (no combined surgeries will be performed),
- Narrow iridocorneal angles defined as a Shaffer grade ≤ 2 or presence of iris bombé,
- Endothelial cell density \< 1500 cells/mm²,
- Presence of other significant pathologies in the study eye (including extensive conjunctival thinning or scarring, optic neuropathy of non-glaucomatous etiology, retinal vein occlusion, retinal artery occlusion, corneal opacification or irregularities, ocular malformations such as microphthalmia, concurrent inflammation/infection),
- Proliferative or severe non-proliferative retinopathy in either eye,
- Any sign of past or present uveitis,
- Severe systemic disease or disabling conditions (including chronic renal failure, history of organ transplantation),
- Current or recent participation in another clinical trial (less than 3 months prior to inclusion),
- Pregnancy or breast-feeding,
- Inability to give informed consent to participate to a clinical investigation.
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04323930
Start Date
June 30 2021
End Date
December 31 2023
Last Update
May 10 2022
Active Locations (1)
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1
SwissVisio Montchoisi
Lausanne, Canton of Vaud, Switzerland, 1006