Punctal Plugs and Iodine Related Discomfort

NCT03396809 | Withdrawn DMC FDA Device

• 1 other identifier: MOD00006043
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: Intravitreal injection of medications has revolutionized the treatment microvascular diseases. These diseases often require regular, life-long injections. Ensuring patient comfort is important for compliance with long-term treatments. Patients receiving regular intravitreal injections often complain of progressive dry eye related discomfort. These symptoms are likely secondary to the use of povidone iodine as an antiseptic. Investigators hypothesize that punctal plugs could reverse the progressive ocular surface discomfort induced by povidone iodine during the post-procedural state.

Conditions

Dry Eye Syndromes

Keywords

punctal plugs; dry eye; ocular surface disease index

Outcome Measures

Primary Outcomes (1)

• Reduction in OSDI scores

  For primary endpoints, investigators expect that participants will report reduced OSDI scores after intravitreal injection after insertion of punctal plug. The Ocular Surface Disease Index, or OSDI, is a series of 12 questions associated with a scale that assesses dry eye disease. It has three subsections that investigate the symptoms, environmental factors, and functional limitations caused by dry eye. Each question has a 5 category Likert scale associated with it with five response options that range from "none of the time" to "all of the time." The final score is calculated by multiplying the sum of the scores by 25 and dividing by the total number of questions answered. A response between 0 and 12 represents normal, 13-22 mild, 23-32 moderate, and greater than 33 severe dry eye disease. The scores range from 0-100. The OSDI scores will be conducted by Elisabeth Sledz, in person after consent and over the telephone thereafter.

  1 year

Secondary Outcomes (1)

• OSDI scores in patients receiving bilateral injections

  1 year

Study Arms (1)

Punctal Plugs

EXPERIMENTAL

This arm of the study receives punctal plug intervention.

Device: Punctal plug

Interventions

Punctal plug DEVICE

Punctal plugs are FDA approved for the treatment of dry eye. They increase lubrication of the eye by blocking the drainage of tears into the lacrimal sac. The nose portion of the plug has a larger diameter which is designed to fit in the canaliculum in order to retain the plug in the punctum. The plugs will be used on-label, as it is FDA approved in the treatment of dry eye. The purpose of punctal plugs are to increase tear volume by preventing drainage of tears into the lacrimal sac. The plugs are removable if necessary. Investigators are not testing this device for effectiveness or safety.

Punctal Plugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients seen at Eye Associates of New Mexico Retina Center or the University of New Mexico Eye Clinic
• Three consecutive monthly intravitreal injections
• Patients whose OSDI score indicate dry eye (score greater than 12)
• Greater than 18 years old
• Males and Females

You may not qualify if:

• previous punctal plugs
• punctal cautery
• active infection
• history of ocular infection
• herpes simplex virus
• herpes zoster virus
• previous eyelid trauma
• surgery
• graft versus host disease
• and thyroid eye disease
• Women whom are pregnant or may become pregnant

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

Eye Associates of New Mexico Retina Center

Albuquerque, New Mexico, 87109, United States

Location

Related Publications (5)

• Georgakopoulos CD, Tsapardoni F, Makri OE. EFFECT OF BROMFENAC ON PAIN RELATED TO INTRAVITREAL INJECTIONS: A Randomized Crossover Study. Retina. 2017 Feb;37(2):388-395. doi: 10.1097/IAE.0000000000001137.

  PMID: 27442130 RESULT

• Jiang J, Wu M, Shen T. The toxic effect of different concentrations of povidone iodine on the rabbit's cornea. Cutan Ocul Toxicol. 2009;28(3):119-24. doi: 10.1080/15569520903080511.

  PMID: 19694608 RESULT

• Naor J, Savion N, Blumenthal M, Assia EI. Corneal endothelial cytotoxicity of diluted povidone--iodine. J Cataract Refract Surg. 2001 Jun;27(6):941-7. doi: 10.1016/s0886-3350(00)00750-1.

  PMID: 11408145 RESULT

• Haddock LJ, Ramsey DJ, Young LH. Complications of subspecialty ophthalmic care: endophthalmitis after intravitreal injections of anti-vascular endothelial growth factor medications. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):257-62. doi: 10.3109/08820538.2014.959616.

  PMID: 25325851 RESULT

• Jehangir N, Bever G, Mahmood SM, Moshirfar M. Comprehensive Review of the Literature on Existing Punctal Plugs for the Management of Dry Eye Disease. J Ophthalmol. 2016;2016:9312340. doi: 10.1155/2016/9312340. Epub 2016 Mar 7.

  PMID: 27088009 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Punctal Plugs

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Jennifer Nelson, COA, ROUB

  jjnelson@eyenm.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigators will be performing a case crossover study. First patients who consent will be asked to complete an Ocular Surface Disease Index (OSDI). Those whose score indicates a diagnosis of dry eye will eligible for the study. Three to five days after their intravitreal injection, patients will be contacted over the telephone and asked to complete the OSDI. At their next visit, one month later, a punctal plug will be inserted before their second injection. Three to five days after their second injection, they will be asked to complete the OSDI over the telephone. At their third visit they will receive an intravitreal injection and three to five days after they will be asked to complete a final OSDI. If patients are receiving bilateral intravitreal injections, and the OSDI survey indicates dry eyes bilaterally, then only one of the eyes will be randomly chosen for plug insertion. The other eye will then be used as a control.

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 11, 2018
• Study Start: July 26, 2017
• Primary Completion: July 7, 2018
• Study Completion: December 7, 2018
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

US (1)