Dry EyeLLLT-LasikNCT07181668
Effect of Low-Level Light Therapy on Ocular Surface Parameters in Patients Undergoing Femto-Lasik Surgery
A study testing Low-Level Light Therapy in people with Dry Eye and Meibomian Gland Dysfunction (Disorder), run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
This study evaluates the role of perioperative low-level light therapy (LLLT) in reducing dry eye disease (DED) symptoms after femtosecond laser-assisted in situ keratomileusis (Femto-LASIK). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye, Meibomian Gland Dysfunction (Disorder), Ocular Surface Disease
- What is being tested?
- Low-Level Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteRomania
- Study dates
- 10 Aug 2024to 30 Jul 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
Who may be able to join
- Adults aged ≥18 years.
- Scheduled for bilateral Femto-LASIK surgery for refractive error correction.
- Willing and able to provide written informed consent.
- Ability and willingness to comply with all study procedures and follow-up visits.
- Baseline ocular surface within normal limits (no pre-existing dry eye or ocular surface disease)
Who cannot join
- Prior diagnosis of ocular surface disease (OSD) or dry eye disease (DED).
- History of ocular surgery in either eye.
- Presence of ocular comorbidities such as glaucoma, corneal dystrophies, or active ocular infections.
- Current or regular use of topical ocular treatments, including lubricants, corticosteroids, cyclosporine, or other drugs for DED or OSD.
- Use of instrumental therapies for ocular surface or tear film optimization (e.g., thermal pulsation, IPL).
- Systemic treatments known to influence tear production (e.g., diuretics, antihistamines, antidepressants, hormone replacement therapy).
- Autoimmune diseases affecting the eyes, including Sjögren's syndrome or rheumatoid arthritis.
- Any intraoperative or postoperative complications that could interfere with ocular surface assessment.
Trial locations and contacts
1 site in 1 country.
Romania1 site
University of Medicine and Pharmacy "Grigore T. Popa" Iași,
Iași
About this study
Official title: Perioperative Low-Level Light Therapy for Ocular Surface Protection in Patients Undergoing Femto-LASIK: A Prospective Double-masked, Randomized Controlled Study
This study evaluates the role of perioperative low-level light therapy (LLLT) in reducing dry eye disease (DED) symptoms after femtosecond laser-assisted in situ keratomileusis (Femto-LASIK). DED is one of the most frequent complications following Femto-LASIK, potentially affecting both visual recovery and patient satisfaction.
In this prospective, multicenter, randomized, double-masked, sham-controlled trial, adult patients undergoing Femto-LASIK were assigned to receive either periocular LLLT (Eye-light® )or sham treatment before and after surgery. Tear film parameters and ocular surface symptoms were assessed at baseline, 1 week, 1 month, and 3 months postoperatively.
Read more
Results showed that patients treated with LLLT maintained stable tear volume and reported fewer ocular discomfort symptoms compared with controls, who experienced significant declines. No adverse events related to LLLT were observed.
These findings suggest that perioperative LLLT is a safe and well-tolerated approach that may help preserve tear film stability and improve postoperative comfort in Femto-LASIK patients.
Read the detailed description
This multicenter, randomized, double-masked, sham-controlled clinical trial was conducted to evaluate the efficacy and safety of perioperative low-level light therapy (LLLT) in preventing dry eye disease (DED) symptoms in patients undergoing femtosecond laser-assisted in situ keratomileusis (Femto-LASIK). The study was performed between August 2024 and June 2025 at the Centro Vista Eye Clinic and the Cai Ferate Clinical Hospital (Iași, Romania) in accordance with the Declaration of Helsinki and institutional ethics approval.
Dry eye disease is a multifactorial condition characterized by tear film instability, ocular surface inflammation, and neurosensory abnormalities. It is among the most common complications after corneal refractive surgery, largely due to the transection of corneal nerves during flap creation and excimer laser ablation, which disrupts the lacrimal functional unit and reduces tear production. This can impair visual recovery and reduce patient satisfaction.
LLLT is a non-invasive photobiomodulation technique that delivers low-intensity, monochromatic red light (633 ± 10 nm) to periocular tissues. It has been shown to improve mitochondrial function, modulate inflammatory pathways, and enhance meibomian gland activity, with potential benefits in ocular surface disease. Its role in the perioperative management of DED after LASIK, however, has not been fully explored.
Eligible participants were consecutive adults (≥18 years) scheduled for Femto-LASIK. Exclusion criteria included pre-existing ocular surface disease or DED, prior ocular surgery, autoimmune disease, use of systemic medications associated with DED, and any intraoperative or postoperative complications that could interfere with evaluation. Both eyes of each patient were included in the analysis.
Participants were randomized (1:1) to receive either LLLT or sham treatment. LLLT was administered with the Eye-light® device (Espansione Marketing S.p.A., Italy) for 15 minutes one week before and one week after surgery. Sham-treated patients underwent the same procedure with less than 30% of the treatment power, ensuring masking. All surgeries were performed by experienced surgeons using standardized LASIK techniques under topical anesthesia, followed by a uniform postoperative regimen including topical antibiotics, corticosteroids, and preservative-free artificial tears.
Clinical assessments were performed at baseline (T0), 1 week postoperatively (T1), 1 month (T2), and 3 months (T3).
Parameters included:
Non-invasive tear break-up time (NIBUT) Tear meniscus height (TMH) Lipid layer interferometry Schirmer I test Dry Eye Questionnaire-5 (DEQ-5)
The primary outcome was the preservation of tear volume and ocular surface parameters at 3 months postoperatively. Secondary outcomes included changes in patient-reported symptoms and tear film stability. Safety was evaluated by monitoring treatment-related adverse events and tolerability.
Statistical analysis was conducted using SPSS (version 30.0). Non-parametric and parametric tests were applied as appropriate, with p < 0.05 considered statistically significant. Sample size calculation ensured adequate power (>0.99) to detect clinically meaningful effects.
A total of 61 patients were randomized, of whom 40 (80 eyes) completed the study (23 in the LLLT group, 17 in the sham group). Patients receiving LLLT showed preserved tear meniscus height, stable Schirmer test values, and unchanged DEQ-5 scores over 3 months, whereas the sham group demonstrated significant deterioration in these parameters. No significant effects were found for NIBUT or interferometry. No treatment-related adverse events were reported, and LLLT was well tolerated.
This is the first prospective randomized trial to evaluate perioperative LLLT in Femto-LASIK patients. The results suggest that LLLT may protect ocular surface health, preserve tear volume, and improve patient comfort after refractive surgery. These findings support further research to optimize treatment protocols and confirm long-term benefits
- Being tested
- Low-Level Light Therapy, Sham (No Treatment)
- Keywords
- Dry eye disease, LLLT, Photobiomodulation
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Light TherapyDevice
The intervention consists of non-invasive periocular photobiomodulation using the Eye-light® device (Espansione Marketing S.p.A., Italy), which delivers low-level monochromatic red light (633 ± 10 nm) through a specially designed mask. Participants receive two 15-minute sessions, one 7 days before and one 7 days after femtosecond laser-assisted in situ keratomileusis (Femto-LASIK). The treatment is designed to stimulate meibomian gland activity, improve tear film stability, and reduce ocular surface inflammation. This protocol is unique compared to standard post-refractive surgery care because it targets cellular mitochondrial activity to enhance tissue repair and anti-inflammatory effects. It is non-pharmacological, non-contact, and well-tolerated, making it suitable for perioperative application. The light is delivered through closed eyelids, ensuring safety and comfort, and the device used is CE-marked for ophthalmic applications.
Sham (No Treatment)Device
Participants in the Control group underwent the same procedural setup as the LLLT group, using the Eye-light® device (Espansione Marketing S.p.A., Italy). Instead of delivering therapeutic light energy, the device operated in demo mode, emitting less than 30% of the full treatment power. This configuration mimicked the visual and sensory aspects of a low-level light therapy session without producing biologically effective photobiomodulation. Sham treatment consisted of two 15-minute sessions, one 7 days before and one 7 days after Femto-LASIK. This design ensured masking of participants and investigators while preventing active therapeutic exposure in the control group.
| Study group | Role | What they receive |
|---|---|---|
| LLLT Group | Experimental | Participants in the LLLT group received periocular low-level light therapy (LLLT) using the Eye-light® device (Espansione Marketing S.p.A., Italy) for 15 minutes per session, one week before and one week after femtosecond laser-assisted in situ keratomileusis (Femto-LASIK). The device delivers red light at 633 ± 10 nm through closed eyelids, targeting the periocular region and meibomian glands to support tear film stability and reduce ocular discomfort. All participants underwent standard Femto-LASIK surgery and received identical postoperative care, including topical antibiotics, corticosteroids, and preservative-free artificial tears. Of the 31 patients initially assigned to the LLLT group, 6 were lost to follow-up, leaving 23 patients (46 eyes) for the final analysis. Receives: Device: Low-Level Light Therapy |
| Sham Group | Sham comparator | Participants in the Control group underwent a sham treatment using the same Eye-light® device with minimal energy (<30% of the full therapeutic dose) for 15 minutes per session, also one week before and one week after surgery. This procedure mimicked LLLT without providing therapeutic light exposure. Postoperative care and clinical assessments were identical to the LLLT group. Of the 30 patients initially assigned to the Control group, 13 were lost at the follow up leaving 17 patients (34 eyes) for the final analysis. Receives: Device: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Preservation after Femto-LASIK with LLLT
The Dry Eye Questionnaire-5 (DEQ-5) is a validated 5-item instrument used to assess the severity of subjective dry eye symptoms. The total score ranges from 0 to 22, with higher scores indicating greater symptom severity. The primary outcome is the change in total DEQ-5 score from baseline to 3 months after surgery, comparing the LLLT group to the control group.
Measured: Baseline (1 week preoperatively, T0) to 3 months postoperatively (T3)
Secondary outcomes (4)
Non-Invasive Tear Break-Up Time (NIBUT)
Non-Invasive Tear Break-Up Time (NIBUT) measures tear film stability by recording the interval (in seconds) between a complete blink and the first appearance of a dry spot on the corneal surface without fluorescein instillation. Higher NIBUT values indicate greater tear film stability, while lower values reflect more severe tear film instability. NIBUT will be assessed at baseline, 1 week, 1 month, and 3 months following treatment. The primary outcome is the change in NIBUT from baseline to 3 months postoperatively, comparing the LLLT and control groups.
Measured: Baseline (T0, 1 week preoperatively), 1 week postoperatively (T1), 1 month postoperatively (T2), 3 months postoperatively (T3)
Tear Lipid Layer Thickness (Interferometry)
Tear Lipid Layer Thickness (LLT), assessed by interferometry, evaluates the quality and stability of the tear film lipid layer. Higher LLT values indicate a thicker lipid layer and greater tear film stability, while lower values reflect lipid deficiency and instability. LLT will be measured at baseline, 1 week, 1 month, and 3 months following treatment. The primary outcome is the change in LLT from baseline to 3 months postoperatively, comparing the LLLT and control groups.
Measured: Baseline (T0, 1 week preoperatively), 1 week postoperatively (T1), 1 month postoperatively (T2), 3 months postoperatively (T3)
Tear Meniscus Height (TMH)
Tear Meniscus Height (TMH) is a non-invasive measure used to quantify tear volume by assessing the vertical height of the tear meniscus at the lower eyelid margin. Higher TMH values indicate greater tear volume, whereas lower values reflect aqueous deficiency. TMH will be evaluated at baseline, 1 week, 1 month, and 3 months following treatment. The primary outcome is the change in TMH from baseline to 3 months postoperatively, comparing the LLLT and control groups.
Measured: Baseline (T0, 1 week preoperatively), 1 week postoperatively (T1), 1 month postoperatively (T2), 3 months postoperatively (T3)
Schirmer Test (without anesthesia)
The Schirmer test without anesthesia measures aqueous tear production by placing a standardized filter paper strip in the lower conjunctival fornix and recording the length of wetting (in millimeters) over 5 minutes. Higher values indicate greater tear secretion, while lower values reflect aqueous deficiency. The Schirmer test will be performed at baseline, 1 week, 1 month, and 3 months following treatment. The primary outcome is the change in Schirmer values from baseline to 3 months postoperatively, comparing the LLLT and control groups.
Measured: Baseline (T0, 1 week preoperatively), 1 week postoperatively (T1), 1 month postoperatively (T2), 3 months postoperatively (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start10 Aug 2024
- Primary completion11 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- This is a randomized, controlled, double-masked, parallel-group trial. Eligible participants undergoing femtosecond laser-assisted in situ keratomileusis (Femto-LASIK) are randomly assigned in a 1:1 ratio to receive either low-level light therapy (LLLT) or a sham treatment. Interventions are administered perioperatively (1 week before and 1 week after surgery), and all clinical outcomes are assessed at baseline, 1 week, 1 month, and 3 months postoperatively. Participants remain in their assigned group for the duration of the study, with no crossover between groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timofte Zorila Mihaela Madalina, Grigore T. Popa University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181668
- Sponsor's protocol ID
- Grigore T. Popa n.54/29.07.24
- Acronym
- LLLT-Lasik
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared, including demographic information (age, sex), baseline and follow-up ocular surface parameters and treatment adherence data. No personally identifiable information will be disclosed. Data will be made available only upon reasonable request and for research purposes approved by an ethics committee or institutional review board.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Low-Level Light Therapy for Ocular Surface Protection in Patients Undergoing Femto-LASIK: A Prospective Double-masked, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07181668
- Acronym / sponsor ID
- LLLT-Lasik / Grigore T. Popa n.54/29.07.24
- Keywords
- Dry eye disease, LLLT, Photobiomodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the role of perioperative low-level light therapy (LLLT) in reducing dry eye disease (DED) symptoms after femtosecond laser-assisted in situ keratomileusis (Femto-LASIK). DED is one of the most frequent complications following Femto-LASIK, potentially affecting both visual recovery and patient satisfaction.
In this prospective, multicenter, randomized, double-masked, sham-controlled trial, adult patients undergoing Femto-LASIK were assigned to receive either periocular LLLT (Eye-light® )or sham treatment before and after surgery. Tear film parameters and ocular surface symptoms were assessed at baseline, 1 week, 1 month, and 3 months postoperatively.
Results showed that patients treated with LLLT maintained stable tear volume and reported fewer ocular discomfort symptoms compared with controls, who experienced significant declines. No adverse events related to LLLT were observed.
These findings suggest that perioperative LLLT is a safe and well-tolerated approach that may help preserve tear film stability and improve postoperative comfort in Femto-LASIK patients.
Detailed description
This multicenter, randomized, double-masked, sham-controlled clinical trial was conducted to evaluate the efficacy and safety of perioperative low-level light therapy (LLLT) in preventing dry eye disease (DED) symptoms in patients undergoing femtosecond laser-assisted in situ keratomileusis (Femto-LASIK). The study was performed between August 2024 and June 2025 at the Centro Vista Eye Clinic and the Cai Ferate Clinical Hospital (Iași, Romania) in accordance with the Declaration of Helsinki and institutional ethics approval.
Dry eye disease is a multifactorial condition characterized by tear film instability, ocular surface inflammation, and neurosensory abnormalities. It is among the most common complications after corneal refractive surgery, largely due to the transection of corneal nerves during flap creation and excimer laser ablation, which disrupts the lacrimal functional unit and reduces tear production. This can impair visual recovery and reduce patient satisfaction.
LLLT is a non-invasive photobiomodulation technique that delivers low-intensity, monochromatic red light (633 ± 10 nm) to periocular tissues. It has been shown to improve mitochondrial function, modulate inflammatory pathways, and enhance meibomian gland activity, with potential benefits in ocular surface disease. Its role in the perioperative management of DED after LASIK, however, has not been fully explored.
Eligible participants were consecutive adults (≥18 years) scheduled for Femto-LASIK. Exclusion criteria included pre-existing ocular surface disease or DED, prior ocular surgery, autoimmune disease, use of systemic medications associated with DED, and any intraoperative or postoperative complications that could interfere with evaluation. Both eyes of each patient were included in the analysis.
Participants were randomized (1:1) to receive either LLLT or sham treatment. LLLT was administered with the Eye-light® device (Espansione Marketing S.p.A., Italy) for 15 minutes one week before and one week after surgery. Sham-treated patients underwent the same procedure with less than 30% of the treatment power, ensuring masking. All surgeries were performed by experienced surgeons using standardized LASIK techniques under topical anesthesia, followed by a uniform postoperative regimen including topical antibiotics, corticosteroids, and preservative-free artificial tears.
Clinical assessments were performed at baseline (T0), 1 week postoperatively (T1), 1 month (T2), and 3 months (T3).
Parameters included:
Non-invasive tear break-up time (NIBUT) Tear meniscus height (TMH) Lipid layer interferometry Schirmer I test Dry Eye Questionnaire-5 (DEQ-5)
The primary outcome was the preservation of tear volume and ocular surface parameters at 3 months postoperatively. Secondary outcomes included changes in patient-reported symptoms and tear film stability. Safety was evaluated by monitoring treatment-related adverse events and tolerability.
Statistical analysis was conducted using SPSS (version 30.0). Non-parametric and parametric tests were applied as appropriate, with p < 0.05 considered statistically significant. Sample size calculation ensured adequate power (>0.99) to detect clinically meaningful effects.
A total of 61 patients were randomized, of whom 40 (80 eyes) completed the study (23 in the LLLT group, 17 in the sham group). Patients receiving LLLT showed preserved tear meniscus height, stable Schirmer test values, and unchanged DEQ-5 scores over 3 months, whereas the sham group demonstrated significant deterioration in these parameters. No significant effects were found for NIBUT or interferometry. No treatment-related adverse events were reported, and LLLT was well tolerated.
This is the first prospective randomized trial to evaluate perioperative LLLT in Femto-LASIK patients. The results suggest that LLLT may protect ocular surface health, preserve tear volume, and improve patient comfort after refractive surgery. These findings support further research to optimize treatment protocols and confirm long-term benefits
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, controlled, double-masked, parallel-group trial. Eligible participants undergoing femtosecond laser-assisted in situ keratomileusis (Femto-LASIK) are randomly assigned in a 1:1 ratio to receive either low-level light therapy (LLLT) or a sham treatment. Interventions are administered perioperatively (1 week before and 1 week after surgery), and all clinical outcomes are assessed at baseline, 1 week, 1 month, and 3 months postoperatively. Participants remain in their assigned group for the duration of the study, with no crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| LLLT Group | Experimental | Device: Low-Level Light TherapyParticipants in the LLLT group received periocular low-level light therapy (LLLT) using the Eye-light® device (Espansione Marketing S.p.A., Italy) for 15 minutes per session, one week before and one week after femtosecond laser-assisted in situ keratomileusis (Femto-LASIK). The device delivers red light at 633 ± 10 nm through closed eyelids, targeting the periocular region and meibomian glands to support tear film stability and reduce ocular discomfort. All participants underwent standard Femto-LASIK surgery and received identical postoperative care, including topical antibiotics, corticosteroids, and preservative-free artificial tears. Of the 31 patients initially assigned to the LLLT group, 6 were lost to follow-up, leaving 23 patients (46 eyes) for the final analysis. |
| Sham Group | Sham comparator | Device: Sham (No Treatment)Participants in the Control group underwent a sham treatment using the same Eye-light® device with minimal energy (<30% of the full therapeutic dose) for 15 minutes per session, also one week before and one week after surgery. This procedure mimicked LLLT without providing therapeutic light exposure. Postoperative care and clinical assessments were identical to the LLLT group. Of the 30 patients initially assigned to the Control group, 13 were lost at the follow up leaving 17 patients (34 eyes) for the final analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged ≥18 years.
- Scheduled for bilateral Femto-LASIK surgery for refractive error correction.
- Willing and able to provide written informed consent.
- Ability and willingness to comply with all study procedures and follow-up visits.
- Baseline ocular surface within normal limits (no pre-existing dry eye or ocular surface disease)
Key exclusion criteria (8 listed)
- Prior diagnosis of ocular surface disease (OSD) or dry eye disease (DED).
- History of ocular surgery in either eye.
- Presence of ocular comorbidities such as glaucoma, corneal dystrophies, or active ocular infections.
- Current or regular use of topical ocular treatments, including lubricants, corticosteroids, cyclosporine, or other drugs for DED or OSD.
- Use of instrumental therapies for ocular surface or tear film optimization (e.g., thermal pulsation, IPL).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Level Light TherapyThe intervention consists of non-invasive periocular photobiomodulation using the Eye-light® device (Espansione Marketing S.p.A., Italy), which delivers low-level monochromatic red light (633 ± 10 nm) through a specially designed mask. Participants receive two 15-minute sessions, one 7 days before and one 7 days after femtosecond laser-assisted in situ keratomileusis (Femto-LASIK). The treatment is designed to stimulate meibomian gland activity, improve tear film stability, and reduce ocular surface inflammation. This protocol is unique compared to standard post-refractive surgery care because it targets cellular mitochondrial activity to enhance tissue repair and anti-inflammatory effects. It is non-pharmacological, non-contact, and well-tolerated, making it suitable for perioperative application. The light is delivered through closed eyelids, ensuring safety and comfort, and the device used is CE-marked for ophthalmic applications. | Device | LLLT Group |
| Sham (No Treatment)Participants in the Control group underwent the same procedural setup as the LLLT group, using the Eye-light® device (Espansione Marketing S.p.A., Italy). Instead of delivering therapeutic light energy, the device operated in demo mode, emitting less than 30% of the full treatment power. This configuration mimicked the visual and sensory aspects of a low-level light therapy session without producing biologically effective photobiomodulation. Sham treatment consisted of two 15-minute sessions, one 7 days before and one 7 days after Femto-LASIK. This design ensured masking of participants and investigators while preventing active therapeutic exposure in the control group. | Device | Sham Group |
Primary outcome
Ocular Surface Preservation after Femto-LASIK with LLLT
Time frame: Baseline (1 week preoperatively, T0) to 3 months postoperatively (T3)
The Dry Eye Questionnaire-5 (DEQ-5) is a validated 5-item instrument used to assess the severity of subjective dry eye symptoms. The total score ranges from 0 to 22, with higher scores indicating greater symptom severity. The primary outcome is the change in total DEQ-5 score from baseline to 3 months after surgery, comparing the LLLT group to the control group.
4 secondary outcomes
Non-Invasive Tear Break-Up Time (NIBUT)
Time frame: Baseline (T0, 1 week preoperatively), 1 week postoperatively (T1), 1 month postoperatively (T2), 3 months postoperatively (T3)
Tear Lipid Layer Thickness (Interferometry)
Time frame: Baseline (T0, 1 week preoperatively), 1 week postoperatively (T1), 1 month postoperatively (T2), 3 months postoperatively (T3)
Tear Meniscus Height (TMH)
Time frame: Baseline (T0, 1 week preoperatively), 1 week postoperatively (T1), 1 month postoperatively (T2), 3 months postoperatively (T3)
Schirmer Test (without anesthesia)
Time frame: Baseline (T0, 1 week preoperatively), 1 week postoperatively (T1), 1 month postoperatively (T2), 3 months postoperatively (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared, including demographic information (age, sex), baseline and follow-up ocular surface parameters and treatment adherence data. No personally identifiable information will be disclosed. Data will be made available only upon reasonable request and for research purposes approved by an ethics committee or institutional review board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Light Therapy in people with Dry Eye and Meibomian Gland Dysfunction (Disorder), run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. 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 25 Sep 2025. 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 Romania. 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. Some participants in this study may receive a placebo. 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?
Ocular Surface Preservation after Femto-LASIK with LLLT (time frame: Baseline (1 week preoperatively, T0) to 3 months postoperatively (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2025.