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

• Sponsor: University of Oklahoma (Other)
• Overall Status: Completed
• CT.gov ID: NCT03945071
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.6
• Patients Per Site Per Month: 7.6

Study Details

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	Intervention/Treatment	Phase
Dry Eye Syndromes; Dry Eye; Ocular Surface Disease	Device: Punctal plug	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: Jun 1, 2019
• Actual Primary Completion Date: Oct 18, 2020
• Actual Study Completion Date: Oct 18, 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
No Intervention: Non-Punctual plug Subjects will not receive temporary punctal plug after intravitreal injection

Outcome Measures

Primary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Dean McGee Eye Institute	Oklahoma City	Oklahoma	United States	73104

Sponsors and Collaborators

• University of Oklahoma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Goldberg RA. How to prevent endophthalmitis after intravitreal injections. Int J Retina Vitreous. 2015 Aug 11;1:12. eCollection 2015.
• Laude A, Lim JW, Srinagesh V, Tong L. The effect of intravitreal injections on dry eye, and proposed management strategies. Clin Ophthalmol. 2017 Aug 16;11:1491-1497. doi: 10.2147/OPTH.S136500. eCollection 2017. Review.
• Marcet MM, Shtein RM, Bradley EA, Deng SX, Meyer DR, Bilyk JR, Yen MT, Lee WB, Mawn LA. Safety and Efficacy of Lacrimal Drainage System Plugs for Dry Eye Syndrome: A Report by the American Academy of Ophthalmology. Ophthalmology. 2015 Aug;122(8):1681-7. doi: 10.1016/j.ophtha.2015.04.034. Epub 2015 May 30. Review.
• Ridder WH 3rd, Oquindo C, Dhamdhere K, Burke J. Effect of Povidone Iodine 5% on the Cornea, Vision, and Subjective Comfort. Optom Vis Sci. 2017 Jul;94(7):732-741. doi: 10.1097/OPX.0000000000001091.
• Saedon H, Nosek J, Phillips J, Narendran N, Yang YC. Ocular surface effects of repeated application of povidone iodine in patients receiving frequent intravitreal injections. Cutan Ocul Toxicol. 2017 Dec;36(4):343-346. doi: 10.1080/15569527.2017.1291665. Epub 2017 Feb 28.

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT03945071
• Other Study ID Numbers: IRB 9810
• First Posted: May 10, 2019
• Last Update Posted: Dec 17, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Dec 17, 2020