Dry Eye DiseaseNCT05553561
Intense Regulated Pulse Light Therapy in Dry Eye Disease
A study testing IPRL device and pharmacological therapy & Eyelid hygiene in people with Dry Eye Disease, run by Menoufia University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the effect of intense regulated pulse light (IRPL) on the treatment of Dry eye. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- IPRL device and pharmacological therapy & Eyelid hygiene
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with moderate to severe dry eye disease \& clinicaily significant signs of meibomian gland dysfunction
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Rofaida Mostafa Mansour, Master degree in ophthalmology contact
About this study
Official title: Therapeutic Effect of Intense Regulated Pulse Light in Patients With Dry Eye Disease
The aim of this study is to assess the effect of intense regulated pulse light (IRPL) on the treatment of Dry eye.
Read the detailed description
Dry eye disease is a common ocular condition that needs prompt diagnosis and careful treatment interventions. If left untreated, it can lead to numerous sight threatening complications, including ulceration of the cornea, blepharitis, alterations of the tear film, conjunctivitis, and in severe cases, significant drying of the eye may lead to scarring, thinning, and even perforation of the cornea.
Intense pulsed light (IPL) therapy is a new treatment strategy for treatment of MGD by inducing the restoration of the normal activity of the meibomian glands. In fact, IPL has been used for treating the patients with facial telangiectasias and erythema of rosacea and also resulted in improvement in ocular surface health.
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.
The aim of this study is to assess the effect of intense regulated pulse light (IRPL) on the treatment of Dry eye.
The study included 34 patients with moderate to severe evaporative dry eye. The symptoms will be assessed with the Dry Eye-Related Quality of Life Score (DEQ-5) Questionnaire. The tear film will be assessed through MediWorks D130+S390L (WDR) which is a device attached to the slit lamp for non-invasive examination of tear film.
Patients will be divided into 2 groups: The 1st group include (17) patients who will be treated with Intense Regulated Pulse Light (IRPL) \& the 2nd group include (17) patients will treated by traditional methods of MGD as Eyelid hygiene, topical lubricant, topical \& systemic antibiotics \& anti-inflammatory agents
IRPL will be done using E-Eye (E-Swin, France) \& each patient will undergo 3 sessions on Day (1), Day (15), and Day (45).
The patients will be reassessed after the 3rd session.
- Conditions
- Dry Eye Disease
- Being tested
- IPRL device, pharmacological therapy & Eyelid hygiene
- Keywords
- IPL therapy, IRPL therapy, Dry eye, MGD
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPRL deviceProcedure or surgery
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.
pharmacological therapy & Eyelid hygieneProcedure or surgery
traditional methods of MGD treatment as Eyelid hygiene, topical preservative free lubricant, topical \& systemic antibiotics \& anti-inflammatory agent
| Study group | Role | What they receive |
|---|---|---|
| IRPL Therapy | Active comparator | 17 patients with moderate to severe evaporative dry eye disease will treated with 3 sessions of IRPL therapy. Receives: 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 Receives: Procedure: pharmacological therapy & Eyelid hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive tear film break up time
assessment of tear film through MediWorks device attached to the slitlamp
Measured: before treatment
Change in Non-invasive tear film break up time
assessment of tear film through MediWorks device attached to the slitlamp
Measured: Within 1 month after completion of treatment
Tear Meniscus Height
assessment of tear film through MediWorks device attached to the slitlamp
Measured: before treatment
Change in Tear Meniscus Height
assessment of tear film through MediWorks device attached to the slitlamp
Measured: Within 1 month after completion of treatment
Lipid layer thickness
assessment of tear film through MediWorks device attached to the slitlamp
Measured: before treatment
Change in Lipid layer thickness
assessment of tear film through MediWorks device attached to the slitlamp
Measured: Within 1 month after completion of treatment
Meibomian glands % loss grading
assessment of tear film through MediWorks device attached to the slitlamp
Measured: before treatment
Change in Meibomian glands % loss grading
assessment of tear film through MediWorks device attached to the slitlamp
Measured: 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.
Measured: 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.
Measured: Within 1 month after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Jan 2023
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rofaida Mostafa Mansour Serag EL Deen, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553561
- Sponsor's protocol ID
- 7/2022OPHT23
- Status last verified
- Feb 2023
- First submitted
- 7 Sep 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Intense Regulated Pulse Light in Patients With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT05553561
- Acronym / sponsor ID
- 7/2022OPHT23
- Conditions
- Dry Eye Disease
- Keywords
- IPL therapy, IRPL therapy, Dry eye, MGD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the effect of intense regulated pulse light (IRPL) on the treatment of Dry eye.
Detailed description
Dry eye disease is a common ocular condition that needs prompt diagnosis and careful treatment interventions. If left untreated, it can lead to numerous sight threatening complications, including ulceration of the cornea, blepharitis, alterations of the tear film, conjunctivitis, and in severe cases, significant drying of the eye may lead to scarring, thinning, and even perforation of the cornea.
Intense pulsed light (IPL) therapy is a new treatment strategy for treatment of MGD by inducing the restoration of the normal activity of the meibomian glands. In fact, IPL has been used for treating the patients with facial telangiectasias and erythema of rosacea and also resulted in improvement in ocular surface health.
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.
The aim of this study is to assess the effect of intense regulated pulse light (IRPL) on the treatment of Dry eye.
The study included 34 patients with moderate to severe evaporative dry eye. The symptoms will be assessed with the Dry Eye-Related Quality of Life Score (DEQ-5) Questionnaire. The tear film will be assessed through MediWorks D130+S390L (WDR) which is a device attached to the slit lamp for non-invasive examination of tear film.
Patients will be divided into 2 groups: The 1st group include (17) patients who will be treated with Intense Regulated Pulse Light (IRPL) \& the 2nd group include (17) patients will treated by traditional methods of MGD as Eyelid hygiene, topical lubricant, topical \& systemic antibiotics \& anti-inflammatory agents
IRPL will be done using E-Eye (E-Swin, France) \& each patient will undergo 3 sessions on Day (1), Day (15), and Day (45).
The patients will be reassessed after the 3rd session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRPL Therapy | Active comparator | Procedure: IPRL device17 patients with moderate to severe evaporative dry eye disease will treated with 3 sessions of IRPL therapy. |
| Non IRPL Therapy | Active comparator | Procedure: pharmacological therapy & Eyelid hygiene17 patients with moderate to severe evaporative dry eye disease will treated with traditional methods of MGD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with moderate to severe dry eye disease \& clinicaily significant signs of meibomian gland dysfunction
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPRL deviceIntense 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. | Procedure or surgery | IRPL Therapy |
| pharmacological therapy & Eyelid hygienetraditional methods of MGD treatment as Eyelid hygiene, topical preservative free lubricant, topical \& systemic antibiotics \& anti-inflammatory agent | Procedure or surgery | Non IRPL Therapy |
Primary outcome
Non-invasive tear film break up time
Time frame: before treatment
assessment of tear film through MediWorks device attached to the slitlamp
Change in Non-invasive tear film break up time
Time frame: Within 1 month after completion of treatment
assessment of tear film through MediWorks device attached to the slitlamp
Tear Meniscus Height
Time frame: before treatment
assessment of tear film through MediWorks device attached to the slitlamp
Change in Tear Meniscus Height
Time frame: Within 1 month after completion of treatment
assessment of tear film through MediWorks device attached to the slitlamp
Lipid layer thickness
Time frame: before treatment
assessment of tear film through MediWorks device attached to the slitlamp
Change in Lipid layer thickness
Time frame: Within 1 month after completion of treatment
assessment of tear film through MediWorks device attached to the slitlamp
Meibomian glands % loss grading
Time frame: before treatment
assessment of tear film through MediWorks device attached to the slitlamp
Change in Meibomian glands % loss grading
Time frame: Within 1 month after completion of treatment
assessment of tear film through MediWorks device attached to the slitlamp
patient's quality of life affection
Time frame: before treatment
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.
Change in patient's quality of life affection
Time frame: Within 1 month after completion of treatment
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rofaida Mostafa Mansour, Master degree in ophthalmology contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPRL device and pharmacological therapy & Eyelid hygiene in people with Dry Eye Disease, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rofaida Mostafa Mansour, Master degree in ophthalmology (01000502442, drrofaidamostafa1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-invasive tear film break up time (time frame: before treatment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.