NCT03945071

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2020

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

February 10, 2019

Last Update Submit

November 30, 2023

Conditions

Dry Eye SyndromesDry EyeOcular Surface Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Puntal plug

ACTIVE COMPARATOR

Subjects will receive temporary punctal plug after intravitreal injection

Device: Punctal plug

Non-Punctual plug

NO INTERVENTION

Subjects will not receive temporary punctal plug after intravitreal injection

Interventions

Punctal plugDEVICE

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

Puntal plug

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of age-related macula degeneration
  • Clinical diagnosis of diabetic retinopathy
  • Clinical diagnosis of retinal vein occlusion

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dean McGee Eye Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Related 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.

    PMID: 27847605BACKGROUND

  • 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.

    PMID: 28860698BACKGROUND

  • 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.

    PMID: 26038339BACKGROUND

  • 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.

    PMID: 28609415BACKGROUND

  • 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.

    PMID: 28166657BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Punctal Plugs

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Vinay Shah, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2019

First Posted

May 10, 2019

Study Start

June 1, 2019

Primary Completion

October 18, 2020

Study Completion

October 18, 2020

Last Updated

December 7, 2023

Record last verified: 2023-11

Locations

US(1)