Evaporative Dry EyeNCT05331924
Quality of Life Improvement in Dry Eye Patients After Intense Pulsed Light Therapy Compared to Punctal Plugs
A study testing IPL therapy and Punctal plugs in people with Evaporative Dry Eye, run by Tanta University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evaporative Dry Eye
- What is being tested?
- IPL therapy and Punctal plugs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Feb 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MGD patients with moderate to severe evaporative dry eye.
- Patients older than 18 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- IPL therapy, Punctal plugs
- Keywords
- Dry eye, MGD, IPL therapy, Punctal plugs
- 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.
IPL therapyProcedure 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.
Punctal plugsProcedure or surgery
Silicone punctal plugs are small pieces of silicone designed to block tear drainage through occluding the lacrimal punctum.
| Study group | Role | What they receive |
|---|---|---|
| IPL therapy | Active comparator | Fifteen patients with severe to moderate evaporative dry eye disease were treated with 3 sessions of IPL therapy. Receives: Procedure: IPL therapy |
| Punctal plugs | Active comparator | Fifteen patients with severe to moderate evaporative dry eye disease were treated with silicone punctal plug insertion. Receives: Procedure: Punctal plugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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 posted18 Apr 2022
- Study start1 Dec 2020
- Primary completion1 Dec 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaporative Dry EyeStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Molham Abdelhafez Elbakary, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331924
- Sponsor's protocol ID
- 35345/3/22
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Improvement in Dry Eye Patients After Intense Pulsed Light Therapy Compared to Punctal Plugs
- ClinicalTrials.gov ID
- NCT05331924
- Acronym / sponsor ID
- 35345/3/22
- Conditions
- Evaporative Dry Eye
- Keywords
- Dry eye, MGD, IPL therapy, Punctal plugs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 18 Apr 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPL therapy | Active comparator | Procedure: IPL therapyFifteen patients with severe to moderate evaporative dry eye disease were treated with 3 sessions of IPL therapy. |
| Punctal plugs | Active comparator | Procedure: Punctal plugsFifteen patients with severe to moderate evaporative dry eye disease were treated with silicone punctal plug insertion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- MGD patients with moderate to severe evaporative dry eye.
- Patients older than 18 years old.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| IPL therapyIntense 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 | IPL therapy |
| Punctal plugsSilicone punctal plugs are small pieces of silicone designed to block tear drainage through occluding the lacrimal punctum. | Procedure or surgery | Punctal plugs |
Primary outcome
Patient's quality of life (QOL) affection.
Time frame: before treatment
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.
Change in patient's quality of life (QOL) affection.
Time frame: Within 1 month after completion of treatment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPL therapy and Punctal plugs in people with Evaporative Dry Eye, run by Tanta 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 18 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's quality of life (QOL) affection. (time frame: before treatment). The study lists 2 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 18 Apr 2022.