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Preventive TREatment of Dry Eye in Patients Receiving Repeated Intravitreal Injections for Age-related Macular Degeneration

NCT06174181 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-02-25

No results posted yet for this study

Summary

Age-related macular degeneration (AMD) is the 1st cause of visual impairment after the age of 50. Its most aggressive form, wet AMD, requires regular intravitreal injections (IVI) spaced 4 to 8 weeks apart usually depending on the treatment regimen and the patient's response. The IVI procedure requires a double disinfection with periocular and conjunctival cutaneous povidone-iodine. Antiseptic agents such as povidone iodine are a highly likely factor in the development of dry eye syndrome. Clinical data have demonstrated the abrasive and toxic effects of their use on the ocular surface, especially with repeated exposure (Saedon H, Nosek J, Phillips J. Ocular surface effects of repeated application of povisoden-iodine in patients receiving frequent intravitreal injections. Cutaneous and Ocular Toxicology. 2017;36(4):343-6.). The IVIS study coordinated by Prof. Dot reported impaired ocular surface and quality of life immediately after IVI. The authors suggest 3 levels of action to improve immediate tolerance: (i) improve the basal status of the ocular surface, (ii) reduce the contact time with povidone-iodine which could be toxic to the ocular surface and (iii) improve immediate post-IVI treatment. (Verrecchia S et al. A prospective multicentre study of intravitreal injections and ocular surface in 219 patients: IVIS study. Acta Ophthalmol. 2021 Mar 18). This study is part of the extension of the IVIS study. IVIs are effective and do not currently present a therapeutic alternative. However, their role in the development or exacerbation of dry eye is still poorly evaluated although millions of IVIs are performed each year worldwide (1.3 million in France in 2019). In addition, discomfort after injection is one of the factors that limit adherence to long-term IVI treatment, some patients fearing this repeated act. We propose in this bicentric, prospective, randomized, parallel group study, to evaluate in this context the impact of the continuous consideration of the risk of dry eye. The expected results are the objective improvement of dry eye indicators, comfort and quality of life of patients, all aimed at optimizing the adherence of our patients to their AMD treatment.

Conditions

  • Dry Eye Syndromes
  • Age-Related Macular Degeneration

Interventions

DEVICE

Preservative-free ophtalmic lubricant emulsion

Use of a preservative-free ophtalmic lubricant emulsion continous during 6 months

OTHER

Routine treatment

Use of a preservative-free ophtalmic lubricant emulsion after each intravitreal injection during few days

Sponsors & Collaborators

  • Direction Centrale du Service de Santé des Armées

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-09
Primary Completion
2024-11-14
Completion
2024-11-14

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06174181 on ClinicalTrials.gov