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

Not Applicable

Completed

• Conditions: Dry Eye Syndromes; Dry Eye; Ocular Surface Disease
• Interventions: Device: Punctal plug

• Registration Number: NCT03945071
• Lead Sponsor: University of Oklahoma

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.

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 Timeline

• Study First Submitted: 2019-02-10
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-10
• Study Start: 2019-06-01
• Primary Completion: 2020-10-18
• Study Completion: 2020-10-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Clinical diagnosis of age-related macula degeneration
• Clinical diagnosis of diabetic retinopathy
• Clinical diagnosis of retinal vein occlusion

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Puntal plug	Punctal plug	Subjects will receive temporary punctal plug after intravitreal injection

Primary Outcome Measures

Name	Time	Method
Change in ocular (eye) discomfort	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).

Trial Locations

Locations (1)

Dean McGee Eye Institute; 🇺🇸 Oklahoma City, Oklahoma, United States