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

Dry Eye Clinical Trial

Official title:

The Effect of Punctal Plugs in Reducing Ocular Surface Irritation After Povidone-Iodine Preparation of Intravitreal Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03945071
• Other study ID #: 9810
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: October 18, 2020

Study information

• Verified date: November 2023
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 18, 2020
• Est. primary completion date: October 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Ocular Surface Disease

Intervention

Device:
• Punctal plug
Punctal plug will be given to subjects after intravitreal injection in half of the study subjects

Locations

Country	Name	City	State
United States	Dean McGee Eye Institute	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (5)

Goldberg RA. How to prevent endophthalmitis after intravitreal injections. Int J Retina Vitreous. 2015 Aug 11;1:12. doi: 10.1186/s40942-015-0012-9. eCollection 2015. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ocular (eye) discomfort	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).	From date of randomization until date of death from any cause, whichever came first, assessed up to 100 weeks