Punctal Plugs and Iodine Related Discomfort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-26

Study Completion Date

2018-12-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Punctal Plugs on Ocular Surface After Povidone-Iodine Preparation of Intravitreal Injection

NCT03945071

Dry Eye Syndromes Dry Eye Ocular Surface Disease

COMPLETED NA

Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome

NCT03396913

Dry Eye Syndrome

COMPLETED NA

A Clinical Trial of Povidone-Iodine for the Treatment of Bacterial Corneal Ulcers

NCT00386958

Infected Corneal Ulcers Bacterial Keratitis Corneal Ulcer +1 more

COMPLETED PHASE2

Effect of Povidone-iodine 5% Vs 1% on the Ocular Surface in Intravitreal Injections of Anti-VEGF

NCT06710951

Dry Eye

COMPLETED NA

Usability, Immediate, and 30 Day Effect of External Neuromodulation With iTEAR100 Generation 2 in Dry Eye Patients

NCT05304637

Dry Eye

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye Syndromes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Punctal Plugs

This arm of the study receives punctal plug intervention.

Group Type EXPERIMENTAL

Punctal plug

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes