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

NCT ID: NCT02876185

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-08

Study Completion Date

2023-05-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with glaucoma

Patients presenting an open-angle glaucoma or ocular hypertension

Monitoring by an orthoptist then by an ophthalmologist

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre hospitalier

Angers, , France

Site Status

Hôpital Ambroise-Paré

Boulogne-Billancourt, , France

Site Status

Clinique Universitaire d'Ophtalmologie

Grenoble, , France

Site Status

Fondation Ophtalmologique A de Rothschild

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ICU_2015_39

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Advanced Glaucoma Progression Study
NCT01742819 ACTIVE_NOT_RECRUITING