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

Diabetic Macular Edema Clinical Trial

— PISO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06262737
• Other study ID #: RBHP 2023 CHIAMBARETTA
• Secondary ID: 2023-A01121-44
• Status: Recruiting
• Start date: September 30, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: October 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Degeneration
• Macular Edema
• Retinal Vein Occlusion

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

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