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Laser corneal refractive surgery is a widely adopted approach for correcting refractive errors, but postoperative dry eye remains a common side effect. Intense Pulsed Light (IPL) and Low-Level Light Therapy (LLLT) are two emerging treatments that have shown potential in managing dry eye disease. However, their role as a prophylactic treatment in patients without pre-existing symptomatic dry eye undergoing refractive surgery has not been explored.
monocentric, randomized, simple bling, controlled study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Active Comparator | preventive treatment by IPL+LLLT with EYE-LIGHT, Espansione group |
|
| standard | No Intervention | non preventive treatment by IPL+LLLT with EYE-LIGHT, Espansione group = standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPL+LLLT | Device | preventive treatment by IPL+LLLT (EYE-LIGHT) before laser refractive surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| French version of 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Patients eligible for laser corneal refractive surgery (FS-LASIK, SMILE®, or PRK) who meet the inclusion criteria will be enrolled.
Exclusion criteria include age < 18 and contraindications to IPL or LLLT (e.g., pregnancy, lactation, migraine, epilepsy, palpebral or periocular lesion, photosensitive drugs, cardiac pacing system or implantable cardiovertor defibrillator, Fitzpatrick phototypes V and VI).
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| Name | Affiliation | Role |
|---|---|---|
| BĂ©atrice COCHENER-LAMARD, MD, PhD | Universitary Hospital of Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brest | Brest | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19376264 | Background | Dartt DA. Neural regulation of lacrimal gland secretory processes: relevance in dry eye diseases. Prog Retin Eye Res. 2009 May;28(3):155-77. doi: 10.1016/j.preteyeres.2009.04.003. Epub 2009 Apr 17. | |
| 28736340 | Background | Bron AJ, de Paiva CS, Chauhan SK, Bonini S, Gabison EE, Jain S, Knop E, Markoulli M, Ogawa Y, Perez V, Uchino Y, Yokoi N, Zoukhri D, Sullivan DA. TFOS DEWS II pathophysiology report. Ocul Surf. 2017 Jul;15(3):438-510. doi: 10.1016/j.jtos.2017.05.011. Epub 2017 Jul 20. |
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De-identified (coded/pseudonymised) individual participant data from the TEBeLiD randomized trial that underlie the primary and secondary publications/final study report. Dataset includes baseline demographics/clinical characteristics, randomization group, procedural variables, follow-up outcomes (e.g., F-OSDI/OSDI, tear film break-up time, corneal staining/Oxford score, Schirmer test, meibomian gland assessment/meibography), adverse events, and protocol deviations. A data dictionary and variable coding will be provided.
Data will be available beginning five years and ending fifteen years following the final study report completion
Data access requests will be reviewed by the internal committee of Brest University Hospital (CHU de Brest). Requests must include a research proposal and analysis plan (and ethics approval/exemption if applicable). Approved requestors will be required to sign and comply with a data access/data use agreement (no re-identification; secure storage; no onward sharing; acknowledgement/citation of TEBeLiD investigators). Data will be provided via secure transfer or controlled-access environment.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 17, 2026 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D012904 | Smiling |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005149 | Facial Expression |
| D009633 | Nonverbal Communication |
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Treatment group = LLLT+IPL (EYE-LIGHT) before laser refractive surgery
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| 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 |
| Evolution of Meibomian Gland Dropout over the 6 first months post-operative | Meibomian Gland Dropout: Evaluated via infrared images using LipiView™ II (Quantel Medical) and graded using the Gestalt Grading Scale (GGS), which scores meibomian gland loss on a scale from 1 (no loss) to 4 (>75% loss). | 6 months post-operative |
| 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 |
| Evolution of visual acuity over the 6 first months post-operative | Visual acuity measured preoperatively (corrected) and postoperatively (uncorrected) using the Early Treatment of Diabetic Retinopathy Study (ETDRS) scale at 4 meters. Visual acuity is scored by adding 30 to the total number of letters read correctly at 4 meters | 6 months post-operative |
| Evolution of the French version of 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 |
| 28736342 | Background | Wolffsohn JS, Arita R, Chalmers R, Djalilian A, Dogru M, Dumbleton K, Gupta PK, Karpecki P, Lazreg S, Pult H, Sullivan BD, Tomlinson A, Tong L, Villani E, Yoon KC, Jones L, Craig JP. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017 Jul;15(3):539-574. doi: 10.1016/j.jtos.2017.05.001. Epub 2017 Jul 20. |
| 32629039 | Background | Tashbayev B, Yazdani M, Arita R, Fineide F, Utheim TP. Intense pulsed light treatment in meibomian gland dysfunction: A concise review. Ocul Surf. 2020 Oct;18(4):583-594. doi: 10.1016/j.jtos.2020.06.002. Epub 2020 Jul 3. |
| 32182637 | Background | Cote S, Zhang AC, Ahmadzai V, Maleken A, Li C, Oppedisano J, Nair K, Busija L, Downie LE. Intense pulsed light (IPL) therapy for the treatment of meibomian gland dysfunction. Cochrane Database Syst Rev. 2020 Mar 18;3(3):CD013559. doi: 10.1002/14651858.CD013559. |
| 26733111 | Background | McDonald M, Patel DA, Keith MS, Snedecor SJ. Economic and Humanistic Burden of Dry Eye Disease in Europe, North America, and Asia: A Systematic Literature Review. Ocul Surf. 2016 Apr;14(2):144-67. doi: 10.1016/j.jtos.2015.11.002. Epub 2015 Dec 28. |
| 28736337 | Background | Stapleton F, Alves M, Bunya VY, Jalbert I, Lekhanont K, Malet F, Na KS, Schaumberg D, Uchino M, Vehof J, Viso E, Vitale S, Jones L. TFOS DEWS II Epidemiology Report. Ocul Surf. 2017 Jul;15(3):334-365. doi: 10.1016/j.jtos.2017.05.003. Epub 2017 Jul 20. |
| 28736341 | Background | 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. |
| 25458707 | Background | 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. |
| 31106754 | Background | 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. |
| 41748188 | Derived | Kerkouri S, Garcin T, Cochener B. Study protocol for a randomised controlled trial to evaluate the prophylactic efficacy of combined intense pulsed light (IPL) and low-level light therapy (LLLT) in preventing laser corneal refractive surgery-induced dry eye: the Treat Eye Before Laser induced Dry (TEBeLiD) study. BMJ Open. 2026 Feb 26;16(2):e095089. doi: 10.1136/bmjopen-2024-095089. |
| D003142 |
| Communication |
| D001519 | Behavior |