Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06262737
Acronym
PISO
Enrollment
50
Registered
2024-02-16
Start date
2023-09-30
Completion date
2025-10-01
Last updated
2024-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema, Macular Degeneration, Retinal Vein Occlusion

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.

Interventions

None listed

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
OSDIbefore the injection and at 1 dayOcular Surface Disease Index: 12 questions treating of either the sensation, the visual impact and the environemental impact of the dry eye disease

Secondary

MeasureTime frameDescription
HMbefore each injectionMH: hauteur méniscal : high of meniscal tear film
AMbefore each injectionAtrophie meibomienne: meibomian atrophy
OSDIbefore the injection and at 1 weekOcular Surface Disease Index: 12 questions treating of either the sensation, the visual impact and the environemental impact of the dry eye disease
NIBUT 2before each injectionAverage Non Invasive Break-Up Time : average time when the tear film lose is regularity for each location
Interferometrybefore each injectionInterferometry: High of the lipid film of the tear
NIBUT 1before each injectionFirst Non Invasive Break-Up Time: time when the tear film lose is regularity regardless of is location

Countries

France

Contacts

Primary ContactLise LACLAUTRE
promo_interne_drci@chu-clermontferrand.fr+33473754963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026