The Effect of Punctal Plugs on Ocular Surface After Povidone-Iodine Preparation of Intravitreal Injection
NCT ID: NCT03945071
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
126 participants
INTERVENTIONAL
2019-06-01
2020-10-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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Puntal plug
Subjects will receive temporary punctal plug after intravitreal injection
Punctal plug
Punctal plug will be given to subjects after intravitreal injection in half of the study subjects
Non-Punctual plug
Subjects will not receive temporary punctal plug after intravitreal injection
No interventions assigned to this group
Interventions
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Punctal plug
Punctal plug will be given to subjects after intravitreal injection in half of the study subjects
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of diabetic retinopathy
* Clinical diagnosis of retinal vein occlusion
Exclusion Criteria
* History of punctal cautery,
* Active ocular infection
* History of ocular infection
* Eyelid trauma
* Eyelid surgery
* Graft versus host disease
* Thyroid eye disease.
18 Years
ALL
No
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Vinay Shah, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma
Locations
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Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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9810
Identifier Type: -
Identifier Source: org_study_id