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Efficacy and Safety of the ExPRESS Implant Versus Deep Sclerectomy in Combined Surgery

NCT03201354 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2017-06-28

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Filtration surgery with Ex-PRESS

Filtration surgery with Ex-PRESS

PROCEDURE

Non penetrating deep sclerectomy

Non penetrating deep sclerectomy

PROCEDURE

Cataract extraction

Cataract surgery and IOL implantation

Sponsors & Collaborators

  • Gregorio Marañón Hospital

    collaborator OTHER

  • Clinica Universidad de Navarra, Universidad de Navarra

    collaborator OTHER

  • Hospital Vall d'Hebron

    collaborator OTHER

  • Hospital Universitario Ramon y Cajal

    collaborator OTHER

  • Hospital San Eloy

    collaborator UNKNOWN

  • Hospital del Mar

    collaborator OTHER

  • Institut Catala de Retina

    lead OTHER

Principal Investigators

  • Alfonso Antón, MD, PhD · Institut Catala de Retina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-06-30
Completion
2016-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03201354 on ClinicalTrials.gov