Ocular Discomfort Assessment After Intravitreal Injections

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-07-01

Brief Summary

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In this study, ocular discomfort following intravitreal injection in naïve patients will be studied, as well as the efficacy of wetting agent (Optive eyewash) to prevent ocular discomfort.

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Detailed Description

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In naive patients, the two first intravitreal injections will be studied. Within the first injection, no wetting agent will be delivered. Within 72hours after this first intravitreal injections, patients will be contacted by phone by a nurse to complete questionnaires on quality of life and on ocular pain and eye discomfort.

After the second injection, a treatment with wetting agent will be prescribed. With 72hours after the second injection, quality of life, ocular discomfort as well as acceptability and tolerance of the eye drops will also be assessed by a phone questionnaire.

Conditions

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Macular Degeneration Diabetic Retinopathy Retinal Artery Occlusion Myopia, Degenerative

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Optive after the second anti-VEGF injection

Naive patients requiring intravitreal injection. Patients will be enrolled in this study within the 2 first intravitreal injections to assess quality of life and ocular discomfort without wetting agent (ie after the first injection) and with wetting agent (ie after the second injection)

Group Type EXPERIMENTAL

Optive

Intervention Type DRUG

Optive eye drops will be prescribed to each included patients after their second intravitreal injection; patients will received 1 drop in the affected eye 2 times a day during 3 days

Interventions

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Optive

Optive eye drops will be prescribed to each included patients after their second intravitreal injection; patients will received 1 drop in the affected eye 2 times a day during 3 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient over 18 years old
* Patient with social healthcare
* Patient understanding French language
* Patient requiring anti-VEGF treatment by intravitreal injection

Exclusion Criteria

* Patient treated by Ozurdex® before
* Patient with known and treated ocular dryness
* Non naive patient for intravitreal injection
* Hypersensitivity to Carmellose
* Patient who received wetting agent within the 3 last months
* History of povidone-iodine allergy
* Pregnant or breastfeeding mother

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No