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

University of Oklahoma (OU)

Status: Completed

Conditions: Dry Eye; Dry Eye Syndromes; Ocular Surface Disease

Treatments: Device: Punctal plug

Study type: Interventional

Funder types: Other

Identifiers

NCT03945071

9810

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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126 participants in 2 patient groups

Puntal plug

Active Comparator group

Description:

Subjects will receive temporary punctal plug after intravitreal injection

Treatment:

Device: Punctal plug

Non-Punctual plug

No Intervention group

Description:

Subjects will not receive temporary punctal plug after intravitreal injection