Evaluation of the Possibility to Delegate Glaucoma Surveillance to Orthoptists in Hospital (GLAUS)

October 18, 2024 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Glaucoma is a progressive optical neuropathy, generally associated with ocular hypertension. The treatment aims to stabilize the visual field deficiencies by lowering the intraocular pressure. Due to the fluctuation of the visual field test and re-test measures, the European recommendations are to obtain 6 visual field tests in 2 years (or one every 4 months) in order to know if the pathology is progressing despite the current treatment (or if the treatment is necessary, in cases of intraocular hypertensions). The lack of ophthalmologists renders the monitoring of a beginning glaucoma, rarely compatible with the present recommendations. It is therefore crucial to evaluate new therapeutic alternatives, when faced to a decreasing medical demography and an increase the patient's needs.

This study should allow to validate the possibility to delegate monitoring tasks to orthoptists during glaucoma surveillance. To organize the delegation of this surveillance to orthoptists would permit a better distribution of the ophthalmologist's activities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

133

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

  • France
      • Angers, France
        • Centre hospitalier
      • Boulogne Billancourt, France
        • Hôpital Ambroise-Paré
      • Grenoble, France
        • Clinique Universitaire d'Ophtalmologie
      • Paris, France, 75019
        • Fondation Ophtalmologique A de Rothschild

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with an open-angle glaucoma or ocular hypertension

Description

Inclusion Criteria:

  • Age from 18 years old or more
  • Open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • Other active ocular pathology
  • Monophthalmic patients
  • Patients requiring a Goldmann visual field exam
  • Opposition of the patient to participate to the trial
  • Pregnant women or breastfeeding
  • Patient under juridical protection
  • Lack of affiliation to social security or universal health coverage

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with glaucoma
Patients presenting an open-angle glaucoma or ocular hypertension
Other: Monitoring by an orthoptist then by an ophthalmologist
At each visit, the usual monitoring tests will be collected and viewed by the orthoptist then by the ophthalmologist concerning the necessity of an anticipated ophthalmological consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
detection by the orthoptists of an abnormality that would require an anticipated ophthalmologic consultation
Time Frame: 20 month of follow-up
20 month of follow-up

Collaborators and Investigators

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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

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 (Actual)

April 8, 2016

Primary Completion (Actual)

May 5, 2023

Study Completion (Actual)

May 5, 2023

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimated)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

October 21, 2024

Last Update Submitted That Met QC Criteria

October 18, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICU_2015_39

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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