Cataract SurgeryEDACSNCT07055022
Low-level Light Therapy Versus Intense Pulsed Light to Prevent Iatrogenic Dry Eye Disease After Cataract Surgery
A study testing LLLT and IPL in people with Cataract Surgery and Eye Dryness, run by Clinique Trenel at 1 site in France.
Trial summary
Dry eye disease (DED) is a frequent ocular surface disease (OSD) of multifactorial origin, characterised by disruption of tear film homeostasis and associated with ocular discomfort and/or visual disturbance. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract Surgery, Eye Dryness
- What is being tested?
- LLLT and IPL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged ≥50 years
- scheduled for bilateral cataract surgery by phacoemulsification
- without current DED treatment, including eye drops, for at least two months before the inclusion
- with preoperative OSDI ≤22 points, indicating absence of DED or mild DED
- who signed the informed consent and are willing to comply with the protocol requirements based on the investigator's judgment
- affiliated with a social security scheme
- with an ability to answer questionnaires and to communicate freely in French.
Who cannot join
- set to undergo implantation of a multifocal intraocular lens
- using contact lenses
- with any of the following in the included eye: (i) age-related macular degeneration (AMD), (ii) previous ocular surgery, (iii) abnormal clinical exam of the ocular surface or (iv) undergoing any ocular treatment
- with systemic contraindications, including autoimmune diseases (e.g., Sjögren syndrome)
- with general contraindications for LLLT or IPL treatment: dark pigmented skin (Fitzpatrick grade ≥5), skin photosensitivity (regardless if innate, pathological or medically-induced), or neurological light sensitivity (e.g. epilepsy, light-induced migraines)
- with contraindications for LLLT or IPL treatment limited to the treatment area: history of skin cancer, skin pigmented lesions, as well as fixed/permanent skin piercings, face tattoos, semi-permanent make-up (including microblading) or skin defects
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- with any concomitant disease or disorder which, in the opinion of the investigator, may put the patient at risk or may influence the result of the study
- with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code
- who cannot comply with the protocol requirements based on the investigator's judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Low-level Light Therapy Versus Intense Pulsed Light to Prevent Iatrogenic Dry Eye Disease After Cataract Surgery: a Randomised Controlled Trial
Dry eye disease (DED) is a frequent ocular surface disease (OSD) of multifactorial origin, characterised by disruption of tear film homeostasis and associated with ocular discomfort and/or visual disturbance. Cataract surgery, which is one of the most often performed interventions worldwide, can induce or worsen the symptoms of DED. Despite lack of guidelines on DED prophylaxis before cataract surgery in the general population, there is a growing interest in this topic due to the high prevalence of postoperative DED. A recent randomised controlled trial (RCT) with one month follow-up showed that prophylactic low-level light therapy (LLLT) before and after cataract surgery in patients without pre-existing DED significantly improved postoperative tear film stability, as well as reduced ocular discomfort, compared to no prophylaxis. Apart from LLLT, another light-based treatment for DED is intense pulsed light (IPL); the treatments have shown favourable outcomes in the management of DED, both as stand-alone choices or in combination.
Read the detailed description
Dry eye disease (DED) is a frequent ocular surface disease (OSD) of multifactorial origin, characterised by disruption of tear film homeostasis and associated with ocular discomfort and/or visual disturbance. Cataract surgery, which is one of the most often performed interventions worldwide, can induce or worsen the symptoms of DED. Despite lack of guidelines on DED prophylaxis before cataract surgery in the general population, there is a growing interest in this topic due to the high prevalence of postoperative DED. A recent randomised controlled trial (RCT) with one month follow-up showed that prophylactic low-level light therapy (LLLT) before and after cataract surgery in patients without pre-existing DED significantly improved postoperative tear film stability, as well as reduced ocular discomfort, compared to no prophylaxis. Apart from LLLT, another light-based treatment for DED is intense pulsed light (IPL); the treatments have shown favourable outcomes in the management of DED, both as stand-alone choices or in combination.
There is currently no comparative data available which would allow to choose between LLLT and IPL as prophylaxis for iatrogenic DED after cataract surgery.
The primary objective of this RCT is to compare LLLT versus IPL as prophylaxis for iatrogenic DED after cataract surgery in terms of patient-reported symptoms of eye dryness at 3 months.
- Conditions
- Cataract Surgery, Eye Dryness
- Being tested
- LLLT, IPL
- Keywords
- IPL, LLLT, Intense Pulse Light, Low Level Light Therapy, cataract surgery, phacoemulsification, prophylaxis, prevention, eye dryness, dry eye disease, DED
- Medical subject headings
- Xerophthalmia, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLLTProcedure or surgery
Also called Low Level Light Therapy, phototherapy, photobiomodulation, cold laser therapy
Patients in the LLLT group will receive 3 sessions of LLLT treatment with Eye-light device (Espansione Group S.p.A., Bologna, Italy) 7 days before phacoemulsification (D-7), 7 days after phacoemulsification (D+7), and 30 days after phacoemulsification (D+30). Each session will consist of 15 minutes of light treatment using a wavelength of 625±40 nm and maximum power of 10 W (maximal total fluence of 32 J/cm2 ± 20% per session) applied on the periorbital region. The patients will be asked to close their eyes during the session. The chosen parameters are currently used in the clinical practice of the participating surgeons as treatment for DED; moreover, similar values are reported in published studies
IPLProcedure or surgery
Also called Intense Pulsed Light
Patients in the IPL group will receive 3 sessions of IPL treatment with OptiClear device (Alma Lasers GmbH, Nuremberg, Germany) at D-7, D+7, and D+30. Each session will comprise 90 homogenously spaced pulses of light (wavelength of 550-650 nm, pulse time 10,12 or 15 ms, pulse repetition rate 1-2 Hz) using an energy density of 8-12 J/cm2 adjusted to Fitzpatrick skin type according to the manufacturer's recommendations. The treatment will be applied to the lower eyelid region. Ultrasound gel, as well as protective eye patches will be used, and the patients will be asked to close their eyes during the session. The chosen parameters are currently used in the clinical practice of the participating surgeons as treatment for DED; moreover, similar values are reported in published studies
| Study group | Role | What they receive |
|---|---|---|
| IPL | Active comparator | Patients in the IPL group will receive 3 sessions of IPL treatment with OptiClear device (Alma Lasers GmbH, Nuremberg, Germany) at D-7, D+7, and D+30. Each session will comprise 90 homogenously spaced pulses of light (wavelength of 550-650 nm, pulse time 10,12 or 15 ms, pulse repetition rate 1-2 Hz) using an energy density of 8-12 J/cm2 adjusted to Fitzpatrick skin type according to the manufacturer's recommendations. The treatment will be applied to the lower eyelid region. Ultrasound gel, as well as protective eye patches will be used, and the patients will be asked to close their eyes during the session. The chosen parameters are currently used in the clinical practice of the participating surgeons as treatment for DED; moreover, similar values are reported in published studies Receives: Procedure: IPL |
| LLLT | Experimental | Patients in the LLLT group will receive 3 sessions of LLLT treatment with Eye-light device (Espansione Group S.p.A., Bologna, Italy) 7 days before phacoemulsification (D-7), 7 days after phacoemulsification (D+7), and 30 days after phacoemulsification (D+30). Each session will consist of 15 minutes of light treatment using a wavelength of 625±40 nm and maximum power of 10 W (maximal total fluence of 32 J/cm2 ± 20% per session) applied on the periorbital region. The patients will be asked to close their eyes during the session. The chosen parameters are currently used in the clinical practice of the participating surgeons as treatment for DED; moreover, similar values are reported in published studies Receives: Procedure: LLLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported symptoms of eye dryness (OSDI)
Participants will be asked to report the symptoms of eye dryness by answering an OSDI questionnaire assisted by a member of the medical staff (blinded to the randomisation). OSDI is a widely used, validated questionnaire for the diagnosis of DED and evaluation of its severity and consists of 12 items graded from 0 (never) to 4 (all the time). The final OSDI score is within the range of 0 (no disability) to 100 (complete disability) and is calculated based on the following formula: [(sum of scores for the questions answered) × 25] / (total number of questions answered).
Measured: 3 months after cataract surgery
Secondary outcomes (10)
Patient-reported symptoms of eye dryness (OSDI)
Participants will be asked to report the symptoms of eye dryness by answering an OSDI questionnaire assisted by a member of the medical staff (blinded to the randomisation). OSDI is a widely used, validated questionnaire for the diagnosis of DED and evaluation of its severity and consists of 12 items graded from 0 (never) to 4 (all the time). The final OSDI score is within the range of 0 (no disability) to 100 (complete disability) and is calculated based on the following formula: [(sum of scores for the questions answered) × 25] / (total number of questions answered).
Measured: 1 week, 1 month after cataract surgery
patient-reported symptoms of eye dryness (SANDE)
Participants will answer a Symptom Assessment in Dry Eye (SANDE) questionnaire assisted by a member of the medical staff (blinded to the randomisation). SANDE consists of two questions: "How often, on average, do your eyes feel dry and/or irritated?" and "How severe, on average, do you feel your symptoms of dryness and/or irritation are?". The patient answers both of them on a 100-mm horizontal visual analogue scale (VAS). The location of the mark made by the patient for each question is measured in mm from the left-hand side of the 100-mm line. The final score is calculated by multiplying frequency and severity scores and calculating the square root of the result
Measured: 1 week after, 1 month after and 3 months after the surgery
Non-invasive tear film break-up time (NIBUT)
Automated corneal surface analysis using CA-900 corneal topographer (Topcon Healthcare, Tokyo, Japan)
Measured: 1 week, 1 and 3 months after cataract surgery
Ocular redness
Automated corneal surface analysis using CA-900 corneal topographer (Topcon Healthcare, Tokyo, Japan), on 0-4 Efron scale, grade 0 corresponding to normal ocular redness; a high quality image is obtained with CA-900 and Efron scale is displayed on the screen for a manual comparison
Measured: 1 week after, 1 and 3 months after cataract surgery
Meibomian gland (MG) atrophy
- Automated corneal surface analysis using CA-900 corneal topographer (Topcon Healthcare, Tokyo, Japan), on 1-4 scale, grade 1 corresponding to <25% of MG atrophy; grade 2: 25% < atrophy < 50%; grade 3: 50% < atrophy < 75%; grade 4: atrophy > 75%
Measured: 1 week, 1 and 3 months after cataract surgery
Fluorescein corneal staining (FCS)
With 0.5% fluorescein (SERB SA, Bruxelles, Belgium) assessed under a slit lamp, on 1-4 scale, grade 1 corresponding to no punctate staining; grade 2: no punctate staining but eye tearing/watering; grade 3: localised punctate staining; grade 4: diffuse punctate staining or staining fused in plaques
Measured: 1 week, 1 and 3 months after cataract surgery
Eyelid telangiectasias
Assessed under a slit lamp, on 1-4 scale, grade 1 corresponding to no telangiectasias; grade 2: eyelid (skin) or eyelid margin telangiectasias; grade 3: superficial telangiectasias of inferior palpebral conjunctiva; grade 4: deep telangiectasias of inferior palpebral conjunctiva
Measured: 1 week after, 1 and 3 months after cataract surgery
Meibomian expressiblity and quality
Assessed under a slit lamp, on 1-4 scale, grade 1 corresponding to no MG obstruction, clear and easily expressed meibum; grade 2: cloudy meibum of abnormal viscosity; grade 3: thick, toothpaste-like or filament-like meibum, difficult to express; grade 4: MG obstruction with no meibum expression even under significant pressure
Measured: 1 week, 1 and 3 months after cataract surgery,
Ultrasound energy delivered
Collected during the cataract surgery as cumulative dissipated energy (CDE), obtained as an automatically calculated value displayed at the end of the surgery on the screen of the phacoemulsification system
Measured: Intra-operatively
Adverse Events
Including complications and reoperations, specifying the incidence, severity, and relationship to the treatment applied
Measured: 0 to 3 months after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised controlled surgeon-blinded, evaluator-blinded monocentric trial in a non-inferiority framework with a 1:1 allocation ratio.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Trenel
- Sponsor type
- University, hospital or other
- Collaborators
- ProSurg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055022
- Sponsor's protocol ID
- 2025-A00858-41
- Acronym
- EDACS
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-level Light Therapy Versus Intense Pulsed Light to Prevent Iatrogenic Dry Eye Disease After Cataract Surgery: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07055022
- Acronym / sponsor ID
- EDACS / 2025-A00858-41
- Conditions
- Cataract Surgery, Eye Dryness
- Keywords
- IPL, LLLT, Intense Pulse Light, Low Level Light Therapy, cataract surgery, phacoemulsification, prophylaxis, prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Clinique TrenelUniversity, hospital or other
- Collaborators
- ProSurg
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Jul 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.
Dry eye disease (DED) is a frequent ocular surface disease (OSD) of multifactorial origin, characterised by disruption of tear film homeostasis and associated with ocular discomfort and/or visual disturbance. Cataract surgery, which is one of the most often performed interventions worldwide, can induce or worsen the symptoms of DED. Despite lack of guidelines on DED prophylaxis before cataract surgery in the general population, there is a growing interest in this topic due to the high prevalence of postoperative DED. A recent randomised controlled trial (RCT) with one month follow-up showed that prophylactic low-level light therapy (LLLT) before and after cataract surgery in patients without pre-existing DED significantly improved postoperative tear film stability, as well as reduced ocular discomfort, compared to no prophylaxis. Apart from LLLT, another light-based treatment for DED is intense pulsed light (IPL); the treatments have shown favourable outcomes in the management of DED, both as stand-alone choices or in combination.
Detailed description
Dry eye disease (DED) is a frequent ocular surface disease (OSD) of multifactorial origin, characterised by disruption of tear film homeostasis and associated with ocular discomfort and/or visual disturbance. Cataract surgery, which is one of the most often performed interventions worldwide, can induce or worsen the symptoms of DED. Despite lack of guidelines on DED prophylaxis before cataract surgery in the general population, there is a growing interest in this topic due to the high prevalence of postoperative DED. A recent randomised controlled trial (RCT) with one month follow-up showed that prophylactic low-level light therapy (LLLT) before and after cataract surgery in patients without pre-existing DED significantly improved postoperative tear film stability, as well as reduced ocular discomfort, compared to no prophylaxis. Apart from LLLT, another light-based treatment for DED is intense pulsed light (IPL); the treatments have shown favourable outcomes in the management of DED, both as stand-alone choices or in combination.
There is currently no comparative data available which would allow to choose between LLLT and IPL as prophylaxis for iatrogenic DED after cataract surgery.
The primary objective of this RCT is to compare LLLT versus IPL as prophylaxis for iatrogenic DED after cataract surgery in terms of patient-reported symptoms of eye dryness at 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomised controlled surgeon-blinded, evaluator-blinded monocentric trial in a non-inferiority framework with a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| IPL | Active comparator | Procedure: IPLPatients in the IPL group will receive 3 sessions of IPL treatment with OptiClear device (Alma Lasers GmbH, Nuremberg, Germany) at D-7, D+7, and D+30. Each session will comprise 90 homogenously spaced pulses of light (wavelength of 550-650 nm, pulse time 10,12 or 15 ms, pulse repetition rate 1-2 Hz) using an energy density of 8-12 J/cm2 adjusted to Fitzpatrick skin type according to the manufacturer's recommendations. The treatment will be applied to the lower eyelid region. Ultrasound gel, as well as protective eye patches will be used, and the patients will be asked to close their eyes during the session. The chosen parameters are currently used in the clinical practice of the participating surgeons as treatment for DED; moreover, similar values are reported in published studies |
| LLLT | Experimental | Procedure: LLLTPatients in the LLLT group will receive 3 sessions of LLLT treatment with Eye-light device (Espansione Group S.p.A., Bologna, Italy) 7 days before phacoemulsification (D-7), 7 days after phacoemulsification (D+7), and 30 days after phacoemulsification (D+30). Each session will consist of 15 minutes of light treatment using a wavelength of 625±40 nm and maximum power of 10 W (maximal total fluence of 32 J/cm2 ± 20% per session) applied on the periorbital region. The patients will be asked to close their eyes during the session. The chosen parameters are currently used in the clinical practice of the participating surgeons as treatment for DED; moreover, similar values are reported in published studies |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- aged ≥50 years
- scheduled for bilateral cataract surgery by phacoemulsification
- without current DED treatment, including eye drops, for at least two months before the inclusion
- with preoperative OSDI ≤22 points, indicating absence of DED or mild DED
- who signed the informed consent and are willing to comply with the protocol requirements based on the investigator's judgment
Key exclusion criteria (9 listed)
- set to undergo implantation of a multifocal intraocular lens
- using contact lenses
- with any of the following in the included eye: (i) age-related macular degeneration (AMD), (ii) previous ocular surgery, (iii) abnormal clinical exam of the ocular surface or (iv) undergoing any ocular treatment
- with systemic contraindications, including autoimmune diseases (e.g., Sjögren syndrome)
- with general contraindications for LLLT or IPL treatment: dark pigmented skin (Fitzpatrick grade ≥5), skin photosensitivity (regardless if innate, pathological or medically-induced), or neurological light sensitivity (e.g. epilepsy, light-induced migraines)
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 |
|---|---|---|
| LLLTAlso: Low Level Light Therapy, phototherapy, photobiomodulation, cold laser therapyPatients in the LLLT group will receive 3 sessions of LLLT treatment with Eye-light device (Espansione Group S.p.A., Bologna, Italy) 7 days before phacoemulsification (D-7), 7 days after phacoemulsification (D+7), and 30 days after phacoemulsification (D+30). Each session will consist of 15 minutes of light treatment using a wavelength of 625±40 nm and maximum power of 10 W (maximal total fluence of 32 J/cm2 ± 20% per session) applied on the periorbital region. The patients will be asked to close their eyes during the session. The chosen parameters are currently used in the clinical practice of the participating surgeons as treatment for DED; moreover, similar values are reported in published studies | Procedure or surgery | LLLT |
| IPLAlso: Intense Pulsed LightPatients in the IPL group will receive 3 sessions of IPL treatment with OptiClear device (Alma Lasers GmbH, Nuremberg, Germany) at D-7, D+7, and D+30. Each session will comprise 90 homogenously spaced pulses of light (wavelength of 550-650 nm, pulse time 10,12 or 15 ms, pulse repetition rate 1-2 Hz) using an energy density of 8-12 J/cm2 adjusted to Fitzpatrick skin type according to the manufacturer's recommendations. The treatment will be applied to the lower eyelid region. Ultrasound gel, as well as protective eye patches will be used, and the patients will be asked to close their eyes during the session. The chosen parameters are currently used in the clinical practice of the participating surgeons as treatment for DED; moreover, similar values are reported in published studies | Procedure or surgery | IPL |
Primary outcome
Patient-reported symptoms of eye dryness (OSDI)
Time frame: 3 months after cataract surgery
Participants will be asked to report the symptoms of eye dryness by answering an OSDI questionnaire assisted by a member of the medical staff (blinded to the randomisation). OSDI is a widely used, validated questionnaire for the diagnosis of DED and evaluation of its severity and consists of 12 items graded from 0 (never) to 4 (all the time). The final OSDI score is within the range of 0 (no disability) to 100 (complete disability) and is calculated based on the following formula: [(sum of scores for the questions answered) × 25] / (total number of questions answered).
10 secondary outcomes
Patient-reported symptoms of eye dryness (OSDI)
Time frame: 1 week, 1 month after cataract surgery
patient-reported symptoms of eye dryness (SANDE)
Time frame: 1 week after, 1 month after and 3 months after the surgery
Non-invasive tear film break-up time (NIBUT)
Time frame: 1 week, 1 and 3 months after cataract surgery
Ocular redness
Time frame: 1 week after, 1 and 3 months after cataract surgery
Meibomian gland (MG) atrophy
Time frame: 1 week, 1 and 3 months after cataract surgery
Fluorescein corneal staining (FCS)
Time frame: 1 week, 1 and 3 months after cataract surgery
Eyelid telangiectasias
Time frame: 1 week after, 1 and 3 months after cataract surgery
Meibomian expressiblity and quality
Time frame: 1 week, 1 and 3 months after cataract surgery,
Ultrasound energy delivered
Time frame: Intra-operatively
Adverse Events
Time frame: 0 to 3 months after cataract surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LLLT and IPL in people with Cataract Surgery and Eye Dryness, run by Clinique Trenel 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?
The sponsor lists 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 8 Jul 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathieu De Bats, MD (04 74 78 38 60 ext. +33, mathieudebats@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported symptoms of eye dryness (OSDI) (time frame: 3 months after cataract surgery). 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 8 Jul 2025.