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eyeWatch vs. Trabeculectomy RCT (evT) (evT)

Primary Purpose

Primary Glaucoma

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

eyeWatch

About this trial

This is an interventional treatment trial for Primary Glaucoma

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

SwissVisio Montchoisi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

eyeWatch

Trabeculectomy

Arm Description

Outcomes

Primary Outcome Measures

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.

number of anti glaucoma medications

The number of anti-glaucoma medications will be reported for each visit and compared to the baseline.

Secondary Outcome Measures

Visual acuity

Visual acuity will be measured at each visit and compared to the baseline measurement.

visual field mean deviation

Visual field mean deviation will be measured at each visit and compared to the baseline measurement.

endothelial cell density

the number of endothelial cells will be measured at each visit and compared to the baseline measurement.

Full Information

NCT ID

NCT04323930

First Posted

March 20, 2020

Last Updated

May 4, 2022

Sponsor

Dr. Kaweh Mansouri

Collaborators

Manchester Royal Eye Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04323930

Brief Title

eyeWatch vs. Trabeculectomy RCT (evT)

Acronym

evT

Official Title

Randomized Control Trial of the eyeWatch System as a First-Line Surgical Treatment of Glaucoma vs. MMC-Trabeculectomy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

June 30, 2021 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr. Kaweh Mansouri

Collaborators

Manchester Royal Eye Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 requires surgical treatment. In terms of surgery, the current gold-standard is trabeculectomy. Despite good efficacy, the technique carries relatively high rates of complications. The eyeWatch system has recently received CE-marking for the treatment of open-angle glaucoma. During its initial clinical trial, the eyeWatch system demonstrated good safety and efficacy profile. The present randomized control trial will assess its safety and efficacy against the current gold-standard: trabeculectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

eyeWatch

Arm Type

Experimental

Arm Title

Trabeculectomy

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

eyeWatch

Other Intervention Name(s)

Trabeculectomy

Intervention Description

The eyeWatch system will be implanted as per the manufacturer's instruction, and trabeculectomy will be performed using mitomycin C as per standard surgical protocols.

Primary Outcome Measure Information:

Title

Intraocular pressure (mmHg)

Description

Time Frame

pre-op to month 12

Title

number of anti glaucoma medications

Description

The number of anti-glaucoma medications will be reported for each visit and compared to the baseline.

Time Frame

pre-op to month 12

Secondary Outcome Measure Information:

Title

Visual acuity

Description

Visual acuity will be measured at each visit and compared to the baseline measurement.

Time Frame

baseline to month 12

Title

visual field mean deviation

Description

Visual field mean deviation will be measured at each visit and compared to the baseline measurement.

Time Frame

baseline to month 12

Title

endothelial cell density

Description

the number of endothelial cells will be measured at each visit and compared to the baseline measurement.

Time Frame

baseline to month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

SwissVisio Montchoisi

City

Lausanne

State/Province

Vaud

ZIP/Postal Code

1006

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

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eyeWatch vs. Trabeculectomy RCT (evT)

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