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

Glaucoma Clinical Trial

— GLAUS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876185
• Other study ID #: ICU_2015_39
• Status: Completed
• Start date: April 8, 2016
• Est. completion date: May 5, 2023

Study information

• Verified date: October 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: May 5, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

Locations

Country	Name	City	State
France	Centre hospitalier	Angers
France	Hôpital Ambroise-Paré	Boulogne Billancourt
France	Clinique Universitaire d'Ophtalmologie	Grenoble
France	Fondation Ophtalmologique A de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection by the orthoptists of an abnormality that would require an anticipated ophthalmologic consultation		20 month of follow-up