Punctal Plugs and Iodine Related Discomfort

March 11, 2024 updated by: University of New Mexico

The Use of Punctal Plugs in Reducing Iodine Related Ocular Surface Discomfort

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Retina specialists treat many diseases of the posterior segment of the eye by the delivery of medications via intravitreal injections. Many of these medications are monoclonal antibodies that need to be injected monthly. Endophthalmitis is a sight threatening complication of intravitreal injections. Limiting this complication is of primary importance in any injection protocol. The gold standard antiseptic used in intravitreal injection is Povidone-iodine (PI). PI is used to clean the surrounding ocular adnexa and is used in a 5% dilution on the ocular surface.

PI has been shown to be corrosive to the cornea, delay healing, and cause patients significant discomfort post injection especially for those with dry eye. Non-steroidal anti-inflammatories, topical anesthetics, and anticholinergics have been shown to decrease post injection discomfort1, but these measures are expensive, do not protect against corneal irritation and do not improve the healing capacity of the eye. There is a need for a cost effective measure that can reduce corneal irritation and improve healing due to the effects of PI. 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. Our study would like to investigate the efficacy of punctal plug insertion in the prevention of dry eye symptoms caused by PI following intravitreal injection.

It has been shown that PI is toxic to the cornea at increasing concentrations. Once in contact with corneal epithelium it releases free iodine radicals causing cytotoxicity and apoptosis of cells. This makes it an effective antiseptic for Ophthalmologic procedures, but also causes significant destruction of the healthy corneal tissue2. It has also been shown in rabbits that calf serum is protective against PI induced corneal damage by providing an additional organic substrate for the PI to bind3. It is possible that natural tears can have a similar effect.

Punctal plugs are an extremely cost effective and widely used device to increase the volume of tears on the ocular surface. They block the lacrimal puncta and canalicular system that drains into the nasolacrimal duct, thereby inhibiting drainage of the natural tears into the nasal atria. In patients with dry eye who receive intravitreal injection punctal plugs may be useful in reducing corneal irritation by increasing the volume of natural tears on the ocular surface, which provides an additional organic substrate for the PI solution to bind. This has the potential to decrease the corrosive effects of the PI on the cornea, reduce healing time, and reduce pain in patients with dry eye.

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. There will be no blinding.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Eye Associates of New Mexico Retina Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • previous punctal plugs
  • punctal cautery
  • active infection

  • history of ocular infection

    1. herpes simplex virus
    2. herpes zoster virus

  • previous eyelid trauma

    1. surgery
    2. graft versus host disease
    3. and thyroid eye disease
  • Women whom are pregnant or may become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Punctal Plugs
This arm of the study receives punctal plug intervention.
Device: Punctal plug
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reduction in OSDI scores
Time Frame: 1 year

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
OSDI scores in patients receiving bilateral injections
Time Frame: 1 year

Patients receiving bilateral injections will be analyzed in a subgroup. Only one of their eyes will receive a punctal plug and the other will be used as a control. OSDI scores will be completed for both eyes.

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 sever 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of New Mexico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jennifer Nelson, COA, ROUB, jjnelson@eyenm.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 7, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MOD00006043

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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