The Effect of Punctal Plugs in Reducing Ocular Surface Irritation After Povidone-Iodine Preparation of Intravitreal Injection
| Registry | NCT03945071 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: single, prevention |
| Enrollment | 126 (Actual) |
| Sponsor | University of Oklahoma (Other) |
| Conditions | Dry Eye Syndromes, Dry Eye, Ocular Surface Disease |
| Interventions | Punctal plug (Device) |
| Dates | start 2019-06-01, primary completion 2020-10-18, completion 2020-10-18, first posted 2019-05-10, last updated 2023-12-07 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Dry Eye Syndromes All trials for Dry Eye All trials of Punctal plug
The aim of this study is to evaluate the effectiveness of punctal plugs in reducing ocular surface (eye surface) irritation after intravitreal injections prepared by povidone-iodine 5% solution.
Intravitreal injection is a shot of medication into the eye. Many retinal diseases, such as diabetic retinopathy, neovascular age-related macular degeneration, and retinal vein occlusions require regular, periodic injections. Patients often reports eye surface irritation post intravitreal injection. One of the reasons for such discomfort is attributed to povidone-iodine solution used to clean the eye surface to reduce sight-threatening infections. Patients who already experience symptoms of dry eye are at increased risk of discomfort after povidone-iodine prepped intravitreal injections.
Povidone-iodine is known to be corrosive to the corneal epithelium and delay eye surface healing. Human tears contain proteins and chemicals that lubricate, heal, and protect the eye surface from infections and irritants. Adequate tear film therefore not only dilutes povidone-iodine, but also promotes corneal healing post povidone-iodine prepping.
The primary long-term objective of the present study is to investigate whether punctal plugs will reduce eye discomfort post intravitreal injections as reported by the Ocular Surface Disease Index (OSDI) and other relevant surveys. The secondary outcome is to describe any other risk and protective factors associated with eye surface discomfort after intravitreal injections.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Puntal plug | Active comparator | Device: Punctal plug | Subjects will receive temporary punctal plug after intravitreal injection |
| Non-Punctual plug | No intervention | Subjects will not receive temporary punctal plug after intravitreal injection |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Clinical diagnosis of age-related macula degeneration * Clinical diagnosis of diabetic retinopathy * Clinical diagnosis of retinal vein occlusion Exclusion Criteria: * Currently wearing punctal plugs * History of punctal cautery, * Active ocular infection * History of ocular infection * Eyelid trauma * Eyelid surgery * Graft versus host disease * Thyroid eye disease.
| Facility | City | Country | Status |
|---|---|---|---|
| Dean McGee Eye Institute | Oklahoma City, Oklahoma | United States |