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

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02876185
Collaborator
(none)
133
4
83.7
33.3
0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Monitoring by an orthoptist then by an ophthalmologist

Study Design

Study Type:
Observational
Actual Enrollment :
133 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Actual Study Start Date :
Apr 8, 2016
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. detection by the orthoptists of an abnormality that would require an anticipated ophthalmologic consultation [20 month of follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre hospitalier Angers France
2 Hôpital Ambroise-Paré Boulogne Billancourt France
3 Clinique Universitaire d'Ophtalmologie Grenoble France
4 Fondation Ophtalmologique A de Rothschild Paris France 75019

Sponsors and Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT02876185
Other Study ID Numbers:
  • ICU_2015_39
First Posted:
Aug 23, 2016
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2022