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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

The Effect of Punctal Plugs on Ocular Surface After Povidone-Iodine Preparation of Intravitreal Injection

Clinicaltrials.gov identifier NCT03945071

Recruitment Status Completed

First Posted May 10, 2019

Last update posted December 17, 2020

Study Description

Brief summary:

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.

  • Condition or Disease:Dry Eye Syndromes
    Ocular Surface Disease
    Dry Eye
  • Intervention/Treatment: Device: Punctal plug
  • Phase: N/A
Detailed Description

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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 126 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Single (Investigator)
  • Primary Purpose: Prevention
  • Official Title: The Effect of Punctal Plugs in Reducing Ocular Surface Irritation After Povidone-Iodine Preparation of Intravitreal Injection
  • Actual Study Start Date: June 2019
  • Actual Primary Completion Date: October 2020
  • Actual Study Completion Date: October 2020
Arms and interventions
Arm Intervention/treatment
Active Comparator: Puntal plug
Subjects will receive temporary punctal plug after intravitreal injection
Device: Punctal plug
Punctal plug will be given to subjects after intravitreal injection in half of the study subjects
Outcome Measures
  • Primary Outcome Measures: 1. Change in ocular (eye) discomfort [ Time Frame: From date of randomization until date of death from any cause, whichever came first, assessed up to 100 weeks ]
    Measure participants' level of discomfort after punctal plugs using the Ocular Surface Disease Index (OSDI), which is a paper survey that participants fill out based on their symptoms and level of ocular discomfort (if any).
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts
Locations

United States, Oklahoma
Dean McGee Eye Institute
Oklahoma City

Sponsors and Collaborators

University of Oklahoma

More Information