The Effect of Punctal Plugs on Ocular Surface After Povidone-Iodine Preparation of Intravitreal Injection
Primary Purpose
Dry Eye Syndromes, Dry Eye, Ocular Surface Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Punctal plug
Sponsored by
About this trial
This is an interventional prevention trial for Dry Eye Syndromes
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.
Sites / Locations
- Dean McGee Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Puntal plug
Non-Punctual plug
Arm Description
Subjects will receive temporary punctal plug after intravitreal injection
Subjects will not receive temporary punctal plug after intravitreal injection
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03945071
First Posted
February 10, 2019
Last Updated
December 15, 2020
Sponsor
University of Oklahoma
1. Study Identification
Unique Protocol Identification Number
NCT03945071
Brief Title
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
October 18, 2020 (Actual)
Study Completion Date
October 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Dry Eye, Ocular Surface Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Puntal plug
Arm Type
Active Comparator
Arm Description
Subjects will receive temporary punctal plug after intravitreal injection
Arm Title
Non-Punctual plug
Arm Type
No Intervention
Arm Description
Subjects will not receive temporary punctal plug after intravitreal injection
Intervention Type
Device
Intervention Name(s)
Punctal plug
Intervention Description
Punctal plug will be given to subjects after intravitreal injection in half of the study subjects
Primary Outcome Measure Information:
Title
Change in ocular (eye) discomfort
Description
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).
Time Frame
From date of randomization until date of death from any cause, whichever came first, assessed up to 100 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Dean McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27847605
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.
Results Reference
background
PubMed Identifier
28860698
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.
Results Reference
background
PubMed Identifier
26038339
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.
Results Reference
background
PubMed Identifier
28609415
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.
Results Reference
background
PubMed Identifier
28166657
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.
Results Reference
background
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The Effect of Punctal Plugs on Ocular Surface After Povidone-Iodine Preparation of Intravitreal Injection
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