NCT03201354

Brief Summary

The Ex-PRESS Glaucoma Filtration Device is a small, non-valved implant that was designed to lower intraocular pressure (IOP) by shunting aqueous humor from the anterior chamber into the subconjunctival space. The implant was developed in response to the need for more straightforward, standardized and safe surgical technique than standard filtration surgery. No iridectomy and no sclerectomy is needed if an Ex-PRESS device is implanted under a partial-thickness scleral flap. This may reduce surgical time and complications when compared to a standard trabeculectomy. In some studies it has been found to be safe and effective with few complications, even in high-risk patients. No previous studies have compared filtration surgery with Ex-Press implant to deep sclerectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

3.3 years

First QC Date

December 21, 2011

Last Update Submit

June 26, 2017

Conditions

Open Angle GlaucomaOcular Hypertension

Keywords

GlaucomaOcular hypertensionFiltration surgeryTrabeculectomy with Ex-PRESSNon penetrating deep sclerectomyPhacoemulsificationCombined surgery

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure

    mmHg

    Up to 12 months

Secondary Outcomes (3)

  • Success rate at IOP <18

    Up to 12 months

  • Number of participants with adverse events assesed by questionare in case report file.

    Up to 12 months

  • Number of hypotensive medications needed

    Up to 12 months

Study Arms (2)

Filtration surgery with Express

ACTIVE COMPARATOR

Filtration surgery with Ex-PRESS + cataract extraction (Cataract surgery and IOL implantation)

Procedure: Filtration surgery with Ex-PRESSProcedure: Cataract extraction

Non penetrating surgery

ACTIVE COMPARATOR

\- Filtration surgery with Non penetrating deep sclerectomy + cataract extraction (Cataract surgery and IOL implantation)

Procedure: Non penetrating deep sclerectomyProcedure: Cataract extraction

Interventions

Filtration surgery with Ex-PRESSPROCEDURE

Filtration surgery with Ex-PRESS

Filtration surgery with Express
Non penetrating deep sclerectomyPROCEDURE

Non penetrating deep sclerectomy

Non penetrating surgery
Cataract extractionPROCEDURE

Cataract surgery and IOL implantation

Filtration surgery with ExpressNon penetrating surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of open-angle glaucoma. Points a, b and c will be required:
  • Glaucomatous visual field. Defined as the field presenting at least:
  • A group of 3 or more points with p \< 5% in the pattern deviation map AND
  • One of them with a p \< 1% in the pattern deviation map AND
  • Repeated in at least 2 VF.
  • Glaucomatous optic nerve. Defined as the optic nerve observed in color photographs presenting:
  • Thinning of the neuroretinal rim that can be demonstrated by an alteration in the ISNT rule.
  • Presence of a notch "or"
  • Presence of papillary splinter hemorrhage "or"
  • Presence of a nerve fiber layer defect "or"
  • Cup to disc (C/D) ratio asymmetry \> 0.3 that cannot be explained by asymmetry in the optic disc size "or"
  • C/D ratio \> 0.8 that cannot be explained by a large optic disc size
  • III or IV angle in Shaffer classification
  • Disease poorly controlled with medical treatment and/or laser at the discretion of the ophthalmologist (progression, higher than targeted pressure, poor compliance…)
  • Cataract with visual acuity between 0,1 (20/200) and 0.8 (20/25)

You may not qualify if:

  • Inflammatory, neovasular, closed-angle, normotensive glaucoma secondary to corticoids, or any type of glaucoma with advanced degree of functional lesion (Mean Defect \< -20 dB)
  • Previous glaucoma surgery
  • Previous intraocular ocular surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Catala de Retina

Barcelona, 08017, Spain

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionGlaucoma

Interventions

Filtering SurgeryCataract Extraction

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, OperativeRefractive Surgical Procedures

Study Officials

  • Alfonso Antón, MD, PhD

    Institut Catala de Retina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2011

First Posted

June 28, 2017

Study Start

February 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2016

Last Updated

June 28, 2017

Record last verified: 2017-06

Locations

ES(1)