Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol

Recruiting

• Conditions: Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion

• Registration Number: NCT06262737
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

The purpose of this study is to assess the sensation of ocular dry eye symptom after an intravitreal injection of anti-VEGF.

Detailed Description

The recrutement of the patient is done during the inclusion of the patient by the nurses of the ophtalmological service of clermont-ferrand and confirm by an ophtalmologist of the service.

A mesure of the OSDI is done before the injection, then at 1 day, on week by a phone call. Each of this mesures are done for the 2 other injections.

Before each of this injection, a clinical mesure is done by a lacrydiag: the atrophy of the meibomian glands, the non-invasive break-up time, interferometry, the heigh of the tear meniscum.

Study Timeline

• Study Start: 2023-09-30
• Status Verified: 2023-10
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-16
• Last Update Posted: 2024-02-16
• Primary Completion: 2024-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patient with exsudative age-related macular degeneration, diabetic macular edema or retinal vein occlusion
• Patient with 3 ocular intravitreal injections of anti-VEGF in one eye

Exclusion Criteria

• pregnant or breastfeeding woman
• intravitreal injection before the study
• intravitreal injection in both eyes
• allergy of betadine
• guardianship patient

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OSDI	before the injection and at 1 day	Ocular Surface Disease Index: 12 questions treating of either the sensation, the visual impact and the environemental impact of the dry eye disease

Secondary Outcome Measures

Name	Time	Method
HM	before each injection	MH: hauteur méniscal : high of meniscal tear film
AM	before each injection	Atrophie meibomienne: meibomian atrophy
NIBUT 2	before each injection	Average Non Invasive Break-Up Time : average time when the tear film lose is regularity for each location
OSDI	before the injection and at 1 week	Ocular Surface Disease Index: 12 questions treating of either the sensation, the visual impact and the environemental impact of the dry eye disease
NIBUT 1	before each injection	First Non Invasive Break-Up Time: time when the tear film lose is regularity regardless of is location
Interferometry	before each injection	Interferometry: High of the lipid film of the tear

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France