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

February 15, 2024 updated by: University Hospital, Clermont-Ferrand
The purpose of this study is to assess the sensation of ocular dry eye symptom after an intravitreal injection of anti-VEGF.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patient with retinal injury who will have 3 injections as the induction protocol (1 injection per month) for one eye and that didn't had any injection before.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSDI
Time Frame: 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
before the injection and at 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSDI
Time Frame: 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
before the injection and at 1 week
HM
Time Frame: before each injection
MH: hauteur méniscal : high of meniscal tear film
before each injection
AM
Time Frame: before each injection
Atrophie meibomienne: meibomian atrophy
before each injection
NIBUT 1
Time Frame: before each injection
First Non Invasive Break-Up Time: time when the tear film lose is regularity regardless of is location
before each injection
NIBUT 2
Time Frame: before each injection
Average Non Invasive Break-Up Time : average time when the tear film lose is regularity for each location
before each injection
Interferometry
Time Frame: before each injection
Interferometry: High of the lipid film of the tear
before each injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Frederic CHIAMBARETTA, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2023 CHIAMBARETTA
  • 2023-A01121-44 (Registry Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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