Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery

Dry Eye Clinical Trial

— TEBELID  

Official title:

Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05803798
• Other study ID #: 29BRC22.0190
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2023
• Est. completion date: October 2024

Study information

• Verified date: June 2023
• Source: University Hospital, Brest
• Contact: Béatrice COCHENER-LAMARD, MD, PhD
• Phone: +330229020089
• Email: beatrice.cochener[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

monocentric, randomized, simple bling, controlled study

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye After LASIK-Laser in Situ Keratomileusis
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• IPL+LLLT
preventive treatment by IPL+LLLT (EYE-LIGHT) before laser refractive surgery

Locations

Country	Name	City	State
France	CHU Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month post-operative
Secondary	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.	6 months post-operative
Secondary	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.	6 months post-operative
Secondary	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.	6 months post-operative
Secondary	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.	6 months post-operative
Secondary	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.	6 months post-operative
Secondary	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.	6 months post-operative