Primary Glaucoma Clinical Trial
— evTOfficial title:
Randomized Control Trial of the eyeWatch System as a First-Line Surgical Treatment of Glaucoma vs. MMC-Trabeculectomy
Verified date | May 2022 |
Source | Swiss Vision Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The confirm the performance and safety of the eyeWatch System as first-line filtering surgery and compare its outcomes to trabeculectomy
Status | Enrolling by invitation |
Enrollment | 80 |
Est. completion date | December 31, 2023 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | SwissVisio Montchoisi | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
Dr. Kaweh Mansouri | Manchester Royal Eye Hospital |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraocular pressure (mmHg) | The primary endpoint will be the change in intraocular pressure (mmHg) from pre-operative baseline to 12-month post-operatively. Intraocular pressure will be measure at each visit using Goldmann tonometry. Baseline intraocular pressure will be defined as the mean of the last two pre-operative measurements. | pre-op to month 12 | |
Primary | number of anti glaucoma medications | The number of anti-glaucoma medications will be reported for each visit and compared to the baseline. | pre-op to month 12 | |
Secondary | Visual acuity | Visual acuity will be measured at each visit and compared to the baseline measurement. | baseline to month 12 | |
Secondary | visual field mean deviation | Visual field mean deviation will be measured at each visit and compared to the baseline measurement. | baseline to month 12 | |
Secondary | endothelial cell density | the number of endothelial cells will be measured at each visit and compared to the baseline measurement. | baseline to month 12 |
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