Changes in Choroidal Thickness After Non Penetrating Deep Sclerectomy

May 18, 2017 updated by: Sandra Gómez Sánchez, Germans Trias i Pujol Hospital
Prospective and observational study to determine if choroidal thickness increases after non penetrating deep sclerectomy in patients with open angle glaucoma

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Germans Trias i Pujol Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with progressive open angle glaucoma although topical treatment with indication for non penetrating deep sclerectomy

Description

Inclusion Criteria:

  • Progressive Primary Open Angle Glaucoma

Exclusion Criteria:

  • Age under 18yrs
  • Myopia or Hyperopia higher than -6D or +6D
  • Secondary glaucoma
  • Ocular surgery other than cataract
  • Other ocular pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Choroidal thickness
Time Frame: before and 1 week, 1 month, 3 months and 6 months after non penetrating deep sclerectomy
Choroidal thickness measured by optic coherence tomography
before and 1 week, 1 month, 3 months and 6 months after non penetrating deep sclerectomy
Change in Intraocular pressure
Time Frame: before and 1 week, 1 month, 3 months and 6 months after non penetrating deep sclerectomy
mmHg
before and 1 week, 1 month, 3 months and 6 months after non penetrating deep sclerectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Germans Trias i Pujol Hospital

Collaborators

Pau Romera Romero
Jorge Loscos Arenas
Nevena Romanic Bubalo
Jordi Castellví Manent

Investigators

  • Principal Investigator: Sandra Gómez Sánchez, MD, Germans Trias i Pujol Hospital
  • Principal Investigator: Pau Romera Romero, MD, Germans Trias i Pujol Hospital
  • Principal Investigator: Jorge Loscos Arenas, PhD, Germans Trias i Pujol Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 17, 2017

Primary Completion (ANTICIPATED)

November 17, 2017

Study Completion (ANTICIPATED)

May 17, 2018

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

May 18, 2017

First Posted (ACTUAL)

May 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 18, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OFT-ENP-2017-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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