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AzTrials

Dry EyeTEBELIDNCT05803798

Combined Treatment With Pulsed Light and Photobiomodulation Before Laser Refractive Surgery

A study testing IPL+LLLT in people with Dry Eye and Dry Eye After LASIK-Laser in Situ Keratomileusis, run by University Hospital, Brest at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
IPL+LLLT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteFrance
Study dates
6 Jun 2023to 16 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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).

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Brest

    Brest

Other trials in France

About this study

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.

Read the detailed description

monocentric, randomized, simple bling, controlled study

Being tested
IPL+LLLT
Keywords
dry eye, laser refractive surgery, smile, lasik, presbylasik, photorefractive keratectomy, intense-pulsed light, low-level-light therapy, photobiomodulation
Medical subject headings
Dry Eye Syndromes, Smiling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IPL+LLLTDevice

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

Study groups in NCT05803798
Study groupRoleWhat they receive
treatmentActive comparatorpreventive treatment by IPL+LLLT with EYE-LIGHT, Espansione group
Receives: Device: IPL+LLLT
standardNo interventionnon preventive treatment by IPL+LLLT with EYE-LIGHT, Espansione group = standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 month post-operative

Secondary outcomes (6)

  1. 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.

    Measured: 6 months post-operative

  2. 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.

    Measured: 6 months post-operative

  3. 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).

    Measured: 6 months post-operative

  4. 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.

    Measured: 6 months post-operative

  5. 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

    Measured: 6 months post-operative

  6. 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.

    Measured: 6 months post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2023
  2. Study start6 Jun 2023
  3. Primary completion27 Nov 2024
  4. Study completion16 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Treatment group = LLLT+IPL (EYE-LIGHT) before laser refractive surgery
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05803798
Sponsor's protocol ID
29BRC22.0190
Acronym
TEBELID
Status last verified
Dec 2025
First submitted
21 Mar 2023
Last updated
5 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 19376264

  • 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.

    PubMed 28736340

  • 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.

    PubMed 28736342

  • 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.

    PubMed 32629039

  • 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.

    PubMed 32182637

  • 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.

    PubMed 26733111

  • 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.

    PubMed 28736337

  • 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.

    PubMed 28736341

  • 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.

    PubMed 25458707

  • 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.

    PubMed 31106754

  • 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.

    PubMed 41748188

Questions about this trial

What is this clinical trial studying?

A study testing IPL+LLLT in people with Dry Eye and Dry Eye After LASIK-Laser in Situ Keratomileusis, run by University Hospital, Brest at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

French version of Ocular Surface Disease Index (OSDI) score (time frame: 1 month post-operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05803798, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.

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