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

NCT ID: NCT05331924

Last Updated: 2022-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-02-01

Brief Summary

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.

Conditions

Evaporative Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IPL therapy

Fifteen patients with severe to moderate evaporative dry eye disease were treated with 3 sessions of IPL therapy.

Group Type: ACTIVE_COMPARATOR

IPL therapy

Intervention Type: PROCEDURE

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.

Punctal plugs

Fifteen patients with severe to moderate evaporative dry eye disease were treated with silicone punctal plug insertion.

Group Type: ACTIVE_COMPARATOR

Punctal plugs

Intervention Type: PROCEDURE

Silicone punctal plugs are small pieces of silicone designed to block tear drainage through occluding the lacrimal punctum.

Interventions

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.

Intervention Type: PROCEDURE

Punctal plugs

Silicone punctal plugs are small pieces of silicone designed to block tear drainage through occluding the lacrimal punctum.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Molham Abdelhafez Elbakary

Assistant professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine, Tanta University

Tanta, , Egypt

Countries

Egypt

Other Identifiers

35345/3/22

Identifier Type: -

Identifier Source: org_study_id