Clinical trial NCT03945071: The Effect of Punctal Plugs on Ocular Surface After Povidone-Iodine Preparation of Intravitreal Injection
Official title: The Effect of Punctal Plugs in Reducing Ocular Surface Irritation After Povidone-Iodine Preparation of Intravitreal Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Dry Eye
Ocular Surface Disease
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Change in ocular (eye) discomfort
timeFrame: From date of randomization until date of death from any cause, whichever came first, assessed up to 100 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Dean McGee Eye Institute
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Vinay Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.