Quality of Life Improvement in Dry Eye Patients After Intense Pulsed Light Therapy Compared to Punctal Plugs
Primary Purpose
Evaporative Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
IPL therapy
Punctal plugs
Sponsored by
About this trial
This is an interventional treatment trial for Evaporative Dry Eye focused on measuring Dry eye, MGD, IPL therapy, Punctal plugs
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.
Sites / Locations
- Faculty of Medicine, Tanta University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
IPL therapy
Punctal plugs
Arm Description
Fifteen patients with severe to moderate evaporative dry eye disease were treated with 3 sessions of IPL therapy.
Fifteen patients with severe to moderate evaporative dry eye disease were treated with silicone punctal plug insertion.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05331924
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Evaporative Dry Eye
Keywords
Dry eye, MGD, IPL therapy, Punctal plugs
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IPL therapy
Arm Type
Active Comparator
Arm Description
Fifteen patients with severe to moderate evaporative dry eye disease were treated with 3 sessions of IPL therapy.
Arm Title
Punctal plugs
Arm Type
Active Comparator
Arm Description
Fifteen patients with severe to moderate evaporative dry eye disease were treated with silicone punctal plug insertion.
Intervention Type
Procedure
Intervention Name(s)
IPL therapy
Intervention Description
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
Intervention Name(s)
Punctal plugs
Intervention Description
Silicone punctal plugs are small pieces of silicone designed to block tear drainage through occluding the lacrimal punctum.
Primary Outcome Measure Information:
Title
Patient's quality of life (QOL) affection.
Description
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.
Time Frame
before treatment
Title
Change in patient's quality of life (QOL) affection.
Description
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.
Time Frame
Within 1 month after completion of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Faculty of Medicine, Tanta University
City
Tanta
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Quality of Life Improvement in Dry Eye Patients After Intense Pulsed Light Therapy Compared to Punctal Plugs
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