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

NCT02876185 | Completed

• 1 other identifier: ICU_2015_39
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 4

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.

Conditions

Glaucoma

Keywords

Glaucoma surveillance; Orthoptist

Outcome Measures

Primary Outcomes (1)

• detection by the orthoptists of an abnormality that would require an anticipated ophthalmologic consultation

  20 month of follow-up

Study Arms (1)

Patients with glaucoma

Patients presenting an open-angle glaucoma or ocular hypertension

Other: Monitoring by an orthoptist then by an ophthalmologist

Interventions

Monitoring by an orthoptist then by an ophthalmologist OTHER

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

Patients with glaucoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with an open-angle glaucoma or ocular hypertension

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (4)

Centre hospitalier

Angers, France

Location

Hôpital Ambroise-Paré

Boulogne-Billancourt, France

Location

Clinique Universitaire d'Ophtalmologie

Grenoble, France

Location

Fondation Ophtalmologique A de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 23, 2016
• Study Start: April 8, 2016
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: October 21, 2024

Record last verified: 2024-10

Locations

FR (4)