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

Completed

• Conditions: Glaucoma
• Interventions: Other: Monitoring by an orthoptist then by an ophthalmologist

• Registration Number: NCT02876185
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-08
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-23
• Primary Completion: 2023-05-05
• Study Completion: 2023-05-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with glaucoma	Monitoring by an orthoptist then by an ophthalmologist	Patients presenting an open-angle glaucoma or ocular hypertension

Primary Outcome Measures

Name	Time	Method
detection by the orthoptists of an abnormality that would require an anticipated ophthalmologic consultation	20 month of follow-up

Trial Locations

Locations (4)

Centre hospitalier; 🇫🇷 Angers, France

Hôpital Ambroise-Paré; 🇫🇷 Boulogne Billancourt, France

Clinique Universitaire d'Ophtalmologie; 🇫🇷 Grenoble, France

Fondation Ophtalmologique A de Rothschild; 🇫🇷 Paris, France