Clinical trial NCT05331924: Quality of Life Improvement in Dry Eye Patients After Intense Pulsed Light Therapy Compared to Punctal Plugs
Official title: Quality of Life Improvement in Dry Eye Patients After Intense Pulsed Light Therapy Compared to Punctal Plugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaporative Dry Eye
Keywords: Dry eye
MGD
IPL therapy
Punctal plugs
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Patient's quality of life (QOL) affection.
timeFrame: before treatment
measure: Change in patient's quality of life (QOL) affection.
timeFrame: Within 1 month after completion of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine, Tanta University
Study officials:
References: