Clinical trial NCT05803798: Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery
Official title: Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment group = LLLT+IPL (EYE-LIGHT) before laser refractive surgery
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI) score
timeFrame: 1 month post-operative
Secondary outcomes:
measure: Evolution of Fluorescein Break-up Time (FBUT) over the 6 first months post-operative
timeFrame: 6 months post-operative
measure: Evolution of Schirmer I test over the 6 first months post-operative
timeFrame: 6 months post-operative
measure: Evolution of Meiboscore over the 6 first months post-operative
timeFrame: 6 months post-operative
measure: Evolution of the Oxford score over the 6 first months post-operative
timeFrame: 6 months post-operative
measure: Evolution of visual acuity over the 6 first months post-operative
timeFrame: 6 months post-operative
measure: Evolution of the Ocular Surface Disease Index (OSDI) score over the 6 first months post-operative
timeFrame: 6 months post-operative
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
Study officials:
affiliation: Universitary Hospital of Brest
name: Béatrice COCHENER-LAMARD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.