NCT05553561

Brief Summary

The aim of this study is to assess the effect of intense regulated pulse light (IRPL) on the treatment of Dry eye.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

September 7, 2022

Last Update Submit

February 7, 2023

Conditions

Dry Eye Disease

Keywords

IPL therapyIRPL therapyDry eyeMGD

Outcome Measures

Primary Outcomes (10)

  • Non-invasive tear film break up time

    assessment of tear film through MediWorks device attached to the slitlamp

    before treatment

  • Change in Non-invasive tear film break up time

    assessment of tear film through MediWorks device attached to the slitlamp

    Within 1 month after completion of treatment

  • Tear Meniscus Height

    assessment of tear film through MediWorks device attached to the slitlamp

    before treatment

  • Change in Tear Meniscus Height

    assessment of tear film through MediWorks device attached to the slitlamp

    Within 1 month after completion of treatment

  • Lipid layer thickness

    assessment of tear film through MediWorks device attached to the slitlamp

    before treatment

  • Change in Lipid layer thickness

    assessment of tear film through MediWorks device attached to the slitlamp

    Within 1 month after completion of treatment

  • Meibomian glands % loss grading

    assessment of tear film through MediWorks device attached to the slitlamp

    before treatment

  • Change in Meibomian glands % loss grading

    assessment of tear film through MediWorks device attached to the slitlamp

    Within 1 month after completion of treatment

  • patient's quality of life affection

    The effect of dry eye on the patient's Quality Of Life was evaluated with the aid of Dry Eye-Related Quality of Life Score (DEQ-5) Questionnaire.

    before treatment

  • Change in patient's quality of life affection

    The effect of dry eye on the patient's Quality Of Life was evaluated with the aid of Dry Eye-Related Quality of Life Score (DEQ-5) Questionnaire.

    Within 1 month after completion of treatment

Study Arms (2)

IRPL Therapy

ACTIVE COMPARATOR

17 patients with moderate to severe evaporative dry eye disease will treated with 3 sessions of IRPL therapy.

Procedure: IPRL device

Non IRPL Therapy

ACTIVE COMPARATOR

17 patients with moderate to severe evaporative dry eye disease will treated with traditional methods of MGD

Procedure: pharmacological therapy & Eyelid hygiene

Interventions

IPRL devicePROCEDURE

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.

IRPL Therapy
pharmacological therapy & Eyelid hygienePROCEDURE

traditional methods of MGD treatment as Eyelid hygiene, topical preservative free lubricant, topical \& systemic antibiotics \& anti-inflammatory agent

Non IRPL Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with moderate to severe dry eye disease \& clinicaily significant signs of meibomian gland dysfunction

You may not qualify if:

  • Use systemic medications known to affect the eye two weeks prior to baseline assessment.
  • Pregnancy.
  • Ocular surgery or dermatologic treatments in the previous Two months or during the treatment period.
  • Implants, tattoos, or pigmented lesions in the treatment area.
  • Contraindications to IPL therapy, including the use of photosensitive medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monoufia university

Menoufia, Egypt

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Central Study Contacts

Rofaida Mostafa Mansour, Master degree in ophthalmology

CONTACT

01000502442drrofaidamostafa1989@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmologist at Menoufia university hospitals

Study Record Dates

First Submitted

September 7, 2022

First Posted

September 23, 2022

Study Start

January 1, 2023

Primary Completion

July 1, 2023

Study Completion

December 1, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

EG(1)