Quality of Life Improvement in Dry Eye Patients After Intense Pulsed Light Therapy Compared to Punctal Plugs

Dry eye disease (DED) is a widely spread disorder of tears and ocular surface affecting hundreds of millions around the world. Manifestations resulting from moderate to severe DED have significant effects on the patient's quality of life (QOL). These patients may suffer pain, role limitation, sleep disorders, anxiety, and depression. QOL affection may be comparable to serious illnesses such as renal failure, angina, and disabling fractures.

Evaporative form is the commonest form of DED and it is mainly caused by meibomian glands dysfunction (MGD). The usual traditional treatment options for MGD include warm compresses, expression of meibomian glands (MG), anti-inflammatory drugs, and lubricant eye drops. In many instances, the traditional treatment with artificial tears is not effective.

Non-pharmacological intervention such as punctal occlusion was advocated in these patients. Punctal plugs are designed to block lacrimal drainage, which helps in the preservation of lubricant drops, improving the tear film quantitively and qualitatively. Intense pulsed light therapy (IPL) is another option that has been used by many investigators for the treatment of evaporative dry eye due to MGD safely and effectively.

This study was conducted to compare the improvement of patients' QOL after treatment of severe to moderate evaporative DED with IPL therapy versus silicone punctal plug insertion.

The study included 30 patients with severe to moderate evaporative dry eye secondary to MGD. The effect of DED on patients' QOL was evaluated with the aid of ocular surface disease index (OSDI) questionnaire. Fifteen patients were treated with IPL therapy. The treatment consisted of 3 sessions, with 15 days between the first and second sessions, and 30 days between the second and third sessions. And 15 patients were treated by silicone punctal plug insertion. After the completion of treatment, the Improvement of patients' QOL was evaluated by OSDI questionnaire. The results of both treatments were compared.

Study Overview

• Status: Completed
• Conditions: Evaporative Dry Eye
• Intervention / Treatment: Procedure: IPL therapy; Procedure: Punctal plugs

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Faculty of medicine, Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• MGD patients with moderate to severe evaporative dry eye.
• Patients older than 18 years old.

Exclusion Criteria:

• Patients with dry eye due to auto-immune disorders. e.g.: Sjogren syndrome.
• Patients with conjunctival cicatrizing diseases. e.g.: ocular cicatricial pimphegoid.
• Patients with mild dry eye.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IPL therapy; Fifteen patients with severe to moderate evaporative dry eye disease were treated with 3 sessions of IPL therapy.	Procedure: IPL therapy; Intense pulsed light therapy (IPL) is a non-coherent large wavelength high-intensity light in the range of 500-1200nm. It has been used by many investigators for the treatment of evaporative dry eye safely and effectively.
Active Comparator: Punctal plugs; Fifteen patients with severe to moderate evaporative dry eye disease were treated with silicone punctal plug insertion.	Procedure: Punctal plugs; Silicone punctal plugs are small pieces of silicone designed to block tear drainage through occluding the lacrimal punctum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's quality of life (QOL) affection.	The effect of dry eye on the patient's Quality Of Life (QOL) was evaluated with the aid of the Ocular Surface Disease Index (OSDI) questionnaire. A score of 33 or more indicated severe affection, 23 to 33 indicated moderate, 13 to 22 mild, while 12 or less represented the normal range.	before treatment
Change in patient's quality of life (QOL) affection.	The effect of dry eye on the patient's Quality Of Life (QOL) was evaluated with the aid of the Ocular Surface Disease Index (OSDI) questionnaire. A score of 33 or more indicated severe affection, 23 to 33 indicated moderate, 13 to 22 mild, while 12 or less represented the normal range.	Within 1 month after completion of treatment

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Dry eye; MGD; IPL therapy; Punctal plugs
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 35345/3/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No