The eyeWatch system as first-line treatment in the surgical management of glaucoma compared to trabeculectomy with MMC

not available

ICTRP Trial ID
NCT04323930 (ICTRP)

Official title (approved by ethics committee)
Randomized control trial of the eyeWatch system as a first-line surgical treatment of glaucoma vs. MMC-Trabeculectomy. (BASEC)

Academic title
Randomized Control Trial of the eyeWatch System as a First-Line Surgical Treatment of Glaucoma vs. MMC-Trabeculectomy (ICTRP)

Public title
eyeWatch vs. Trabeculectomy RCT (evT) (ICTRP)

Disease under investigation
Primary Glaucoma
(ICTRP)

Intervention under investigation
Device: eyeWatch
(ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). (ICTRP)

Inclusion/Exclusion criteria
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.
Minimum age: 18 Years
Maximum age: 95 Years
Sex: All (ICTRP)

not available

Primary and secondary end points
Intraocular pressure (mmHg)
number of anti glaucoma medications
(ICTRP)

endothelial cell density
Visual acuity
visual field mean deviation
(ICTRP)

Registration date
20.03.2020 (ICTRP)

Incorporation of the first participant
30.05.2020 (ICTRP)

Secondary sponsors
Manchester Royal Eye Hospital
(ICTRP)

Additional contacts
not available

Secondary trial IDs
evT-2020 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
http://www.who.int/trialsearch/Trial2.aspx?TrialID=NCT04323930 (ICTRP)