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Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery (TEBELID)

Primary Purpose

Dry Eye, Dry Eye After LASIK-Laser in Situ Keratomileusis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IPL+LLLT
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring dry eye, laser refractive surgery, smile, lasik, presbylasik, photorefractive keratectomy, intense-pulsed light, low-level-light therapy, photobiomodulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: ametropia without progression for almost one year pachymetry >480 um myopia < -8 dioptre hyperopia < +6 dioptre astigmatism < -5 dioptre Exclusion Criteria: other ocular disease (such as keratoconus, cataract, glaucoma, AMD, diabetic retinopathy, etc.) infectious or systemic pathology (e.g.: epilepsia, migraine) pregnancy, fitzpatrick V or VI (eye-light contraindication)

Sites / Locations

  • CHU BrestRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

treatment

standard

Arm Description

preventive treatment by IPL+LLLT with EYE-LIGHT, Espansione group

non preventive treatment by IPL+LLLT with EYE-LIGHT, Espansione group = standard care

Outcomes

Primary Outcome Measures

Ocular Surface Disease Index (OSDI) score
The OSDI questionnaire measures frequency of symptoms, environmental triggers and vision related quality of life. OSDI values range from 0 to 100. A score between 13 and 22 excluded indicates a medium intensity eye dryness. A score between 22 and 33 indicated a moderate intensity eye dryness. A score above 33 indicates a severe eye dryness.

Secondary Outcome Measures

Evolution of Fluorescein Break-up Time (FBUT) over the 6 first months post-operative
Sodium fluorescein eye drops is instilled in the eye to enhance visibility of the tear film measure tear film breakup time is. Selected cut-off value is 10 seconds. A score below 10 seconds favors dry eye.
Evolution of Schirmer I test over the 6 first months post-operative
The Schirmer I test, used without anesthesia, provides an estimation of stimulated reflex. Cut-off value used is <= 10 mm / 5 minutes.
Evolution of Meiboscore over the 6 first months post-operative
Measured by Lacriview II, Tear Sciences. Meiboscore correspond to loss of the meibomian glands which is scored using the following grades for each eyelid: 0 : no loss of meibomian glands; 1 : area loss was less than one-third of the total meibomian gland area; 2 : area loss was between one-third and two-thirds; 3 : area loss was more than two-thirds.
Evolution of the Oxford score over the 6 first months post-operative
The Oxford score is composed of 0 to V grades, dependent on intensity of punctate staining displayed. pictorially across a combination of the cornea and conjunctiva.
Evolution of visual acuity over the 6 first months post-operative
Visual acuity measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. The ETDRS chart used 4 m as the standard testing distance and the Sloan family of 5 x 5 letters as the optotypes.
Evolution of the Ocular Surface Disease Index (OSDI) score over the 6 first months post-operative
The OSDI questionnaire measures frequency of symptoms, environmental triggers and vision related quality of life. OSDI values range from 0 to 100. A score between 13 and 22 excluded indicates a medium intensity eye dryness. A score between 22 and 33 indicated a moderate intensity eye dryness. A score above 33 indicates a severe eye dryness.

Full Information

First Posted
March 21, 2023
Last Updated
June 6, 2023
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT05803798
Brief Title
Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery
Acronym
TEBELID
Official Title
Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Ametropia is the first cause of reversible visual trouble. Recently, laser refractive surgery has increased in popularity. Unfortunately, dry eye is a common side effect, representing about 25% of patients after LASIK and 20% after SMILE. Even if symptoms are usually released by artificial tears, there can be very uncomfortable for patients, decrease productivity and quality of life and be the source of unsatisfaction after surgery. The goal of our study is to study the efficiency of a preventive associated treatment by intense-pulsed-light and low-level-light therapy with EYE-LIGHT® device before laser refractive surgery. Recent study confirmed the efficacity of this treatment in meibomian glund dysfunction, the predominant dry eye mecanism.
Detailed Description
monocentric, randomized, simple bling, controlled study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Dry Eye After LASIK-Laser in Situ Keratomileusis
Keywords
dry eye, laser refractive surgery, smile, lasik, presbylasik, photorefractive keratectomy, intense-pulsed light, low-level-light therapy, photobiomodulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Treatment group = LLLT+IPL (EYE-LIGHT) before laser refractive surgery
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Active Comparator
Arm Description
preventive treatment by IPL+LLLT with EYE-LIGHT, Espansione group
Arm Title
standard
Arm Type
No Intervention
Arm Description
non preventive treatment by IPL+LLLT with EYE-LIGHT, Espansione group = standard care
Intervention Type
Device
Intervention Name(s)
IPL+LLLT
Intervention Description
preventive treatment by IPL+LLLT (EYE-LIGHT) before laser refractive surgery
Primary Outcome Measure Information:
Title
Ocular Surface Disease Index (OSDI) score
Description
The OSDI questionnaire measures frequency of symptoms, environmental triggers and vision related quality of life. OSDI values range from 0 to 100. A score between 13 and 22 excluded indicates a medium intensity eye dryness. A score between 22 and 33 indicated a moderate intensity eye dryness. A score above 33 indicates a severe eye dryness.
Time Frame
1 month post-operative
Secondary Outcome Measure Information:
Title
Evolution of Fluorescein Break-up Time (FBUT) over the 6 first months post-operative
Description
Sodium fluorescein eye drops is instilled in the eye to enhance visibility of the tear film measure tear film breakup time is. Selected cut-off value is 10 seconds. A score below 10 seconds favors dry eye.
Time Frame
6 months post-operative
Title
Evolution of Schirmer I test over the 6 first months post-operative
Description
The Schirmer I test, used without anesthesia, provides an estimation of stimulated reflex. Cut-off value used is <= 10 mm / 5 minutes.
Time Frame
6 months post-operative
Title
Evolution of Meiboscore over the 6 first months post-operative
Description
Measured by Lacriview II, Tear Sciences. Meiboscore correspond to loss of the meibomian glands which is scored using the following grades for each eyelid: 0 : no loss of meibomian glands; 1 : area loss was less than one-third of the total meibomian gland area; 2 : area loss was between one-third and two-thirds; 3 : area loss was more than two-thirds.
Time Frame
6 months post-operative
Title
Evolution of the Oxford score over the 6 first months post-operative
Description
The Oxford score is composed of 0 to V grades, dependent on intensity of punctate staining displayed. pictorially across a combination of the cornea and conjunctiva.
Time Frame
6 months post-operative
Title
Evolution of visual acuity over the 6 first months post-operative
Description
Visual acuity measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. The ETDRS chart used 4 m as the standard testing distance and the Sloan family of 5 x 5 letters as the optotypes.
Time Frame
6 months post-operative
Title
Evolution of the Ocular Surface Disease Index (OSDI) score over the 6 first months post-operative
Description
The OSDI questionnaire measures frequency of symptoms, environmental triggers and vision related quality of life. OSDI values range from 0 to 100. A score between 13 and 22 excluded indicates a medium intensity eye dryness. A score between 22 and 33 indicated a moderate intensity eye dryness. A score above 33 indicates a severe eye dryness.
Time Frame
6 months post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ametropia without progression for almost one year pachymetry >480 um myopia < -8 dioptre hyperopia < +6 dioptre astigmatism < -5 dioptre Exclusion Criteria: other ocular disease (such as keratoconus, cataract, glaucoma, AMD, diabetic retinopathy, etc.) infectious or systemic pathology (e.g.: epilepsia, migraine) pregnancy, fitzpatrick V or VI (eye-light contraindication)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Béatrice COCHENER-LAMARD, MD, PhD
Phone
+330229020089
Email
beatrice.cochener@chu-brest.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah KERKOURI, resident
Phone
+330229020089
Email
sarah.kerkouri@chu-brest.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Béatrice COCHENER-LAMARD, MD, PhD
Organizational Affiliation
Universitary Hospital of Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brest
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatrice COCHENER-LAMARD, MD, PhD
Phone
+330229020089
Email
beatrice.cochener@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Beatrice COCHENER-LAMARD, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available beginning five years and ending fifteen years following the final study report completion
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
Citations:
PubMed Identifier
28736341
Citation
Gomes JAP, Azar DT, Baudouin C, Efron N, Hirayama M, Horwath-Winter J, Kim T, Mehta JS, Messmer EM, Pepose JS, Sangwan VS, Weiner AL, Wilson SE, Wolffsohn JS. TFOS DEWS II iatrogenic report. Ocul Surf. 2017 Jul;15(3):511-538. doi: 10.1016/j.jtos.2017.05.004. Epub 2017 Jul 20.
Results Reference
background
PubMed Identifier
25458707
Citation
Denoyer A, Landman E, Trinh L, Faure JF, Auclin F, Baudouin C. Dry eye disease after refractive surgery: comparative outcomes of small incision lenticule extraction versus LASIK. Ophthalmology. 2015 Apr;122(4):669-76. doi: 10.1016/j.ophtha.2014.10.004. Epub 2014 Nov 22.
Results Reference
background
PubMed Identifier
31106754
Citation
Kim TI, Alio Del Barrio JL, Wilkins M, Cochener B, Ang M. Refractive surgery. Lancet. 2019 May 18;393(10185):2085-2098. doi: 10.1016/S0140-6736(18)33209-4.
Results Reference
background
PubMed Identifier
36582033
Citation
Giannaccare G, Pellegrini M, Carnovale Scalzo G, Borselli M, Ceravolo D, Scorcia V. Low-Level Light Therapy Versus Intense Pulsed Light for the Treatment of Meibomian Gland Dysfunction: Preliminary Results From a Prospective Randomized Comparative Study. Cornea. 2023 Feb 1;42(2):141-144. doi: 10.1097/ICO.0000000000002997. Epub 2022 Feb 2.
Results Reference
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Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery

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