Dry EyeNCT05754437
Efficacy of Low-Level Light Therapy in Reducing Dry Eye in Patients Undergoing Cataract Surgery
A study testing Low Level Light Therapy in people with Dry Eye, run by Azienda Ospedaliera Universitaria Mater Domini, Catanzaro at 1 site in Italy.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of Low Level Light Therapy (LLLT) in reducing the incidence or alleviating the severity of DED due to meibomian gland dysfunction in otherwise healthy patients undergoing cataract surgery. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Low Level Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteItaly
- Study dates
- 30 Mar 2022to 30 Apr 2023
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- healthy patients affected by senile cataract
- patients scheduled for phacoemulsification and intraocular lens implantation
Who cannot join
- any other ocular comorbidity (e.g. glaucoma),
- chronic instillation of eye drops of any type
- previous ocular surgery or trauma to the addressed eye
- previous cataract surgery in the controlateral eye,
- active ocular infections
- use of systemic drug with a known or suspected link to dry eye (e.g. diuretics, antidepressants, antihistamines, hormone replacement therapy)
Show all 9Show fewer
- autoimmune diseases (e.g. Sjögren syndrome)
- intraoperative complications (e.g. capsular bag rupture requiring vitrectomy, suprachoroidal hemorrhage)
- postoperative complications (e.g. endophthalmitis, vitritis)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Ophthalmology, University Magna Graecia of Catanzaro
Catanzaro, 88100
About this study
Official title: Effect of Low-Level Light Therapy Prior to Cataract Surgery: A Prospective, Randomized Controlled Study
The goal of this clinical trial is to evaluate the effectiveness of Low Level Light Therapy (LLLT) in reducing the incidence or alleviating the severity of DED due to meibomian gland dysfunction in otherwise healthy patients undergoing cataract surgery.
Participants will be randomly assigned in a 1:1 ratio to either a treatment group or a control group.
The treatment group will receive LLLT one week before and one week after cataract surgery; the control group will not recieve LLLT at any time.
Researchers will compare the treatment and the control group to see if patients receiving LLLT present with reduced signs and symptoms of ocular surface dysfunction with respect to the control group.
- Conditions
- Dry Eye
- Being tested
- Low Level Light Therapy
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Light TherapyDevice
light-emitting diodes (LED), λ = 633 ± 10 nm; power of 100 mW/cm2, 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Low Level Light Therapy Group | Experimental | Patients enrolled in the treatment group will undergo Low Level Light therapy using Meibomask (Espansione Marketing S.p.A., Bologna, Italy) for 15 minutes one week (±2 days) before surgery (T0) and one week (±2 days) after surgery (T1). Receives: Device: Low Level Light Therapy |
| Control group | No intervention | Patients enrolled in the control group will not receive Low Level Light therapy at any time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development or worsening of ocular surface abnormalities: tear meniscus height
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Measurement expressed in millimeters.
Measured: One week (±2 days) after cataract surgery
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) FIRST
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany).
NIKBUT FIRST: interval time between the last complete blinking and the first distortion the 22 concentric rings reflected on the corneal surface. Measurement expressed in seconds.
Measured: One week (±2 days) after cataract surgery
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) AVG
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany).
NIKBUT AVG: average time of all tear film break-ups occurring in the measured period of up to 24.98 seconds (time limit set by the device's software). Measurement expressed in seconds.
Measured: One week (±2 days) after cataract surgery
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) CLASS
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany).
NIKBUT CLASS: classification incorporated in the instrument: class 0 > 10 s (normal), class I 6 - 10 s, class II 3 - 6 s, class III < 3 s.Measurement expressed in seconds.
Measured: One week (±2 days) after cataract surgery
Development or worsening of ocular surface abnormalities: bulbar redness
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). This parameter is expressed as as a ratio of vessels/free sclera and is automatically calculated by the instrument.
Measured: One week (±2 days) after cataract surgery
Development or worsening of ocular surface abnormalities: meibomian gland dropout
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Dropout is calculated according to the JENVIS meibo scale. Grade 0= no dropout; grade 1= area of gland loss up to 33% of the total gland area; grade 2 = area of gland loss between 33 and 66%; grade 3 = area of gland loss of 67% or more
Measured: One week (±2 days) after cataract surgery
Development or worsening of ocular discomfort symptoms.
Evaluation based on the ocular surface disease index (OSDI) questionnaire.
Normal OSDI: 0-12; a score of 13 or more is suggestive of dry eye disease (DED) Mild DED = 13 - 22; Moderate DED = 23-32; Severe DED > 32
Measured: One week (±2 days) after cataract surgery
Development or worsening of ocular surface abnormalities: tear meniscus height
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Measurement expressed in millimeters.
Measured: One month (±7 days) after cataract surgery
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) FIRST
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany).
NIKBUT FIRST: interval time between the last complete blinking and the first distortion the 22 concentric rings reflected on the corneal surface. Measurement expressed in seconds.
Measured: One month (±7 days) after cataract surgery
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) AVG
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany).
NIKBUT AVG: average time of all tear film break-ups occurring in the measured period of up to 24.98 seconds (time limit set by the device's software). Measurement expressed in seconds.
Measured: One month (±7 days) after cataract surgery
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) CLASS
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany).
NIKBUT CLASS: classification incorporated in the instrument: class 0 > 10 s (normal), class I 6 - 10 s, class II 3 - 6 s, class III < 3 s.Measurement expressed in seconds.
Measured: One month (±7 days) after cataract surgery
Development or worsening of ocular surface abnormalities: bulbar redness
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). This parameter is expressed as as a ratio of vessels/free sclera and is automatically calculated by the instrument.
Measured: One month (±7 days) after cataract surgery
Development or worsening of ocular surface abnormalities: meibomian gland dropout
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Dropout is calculated according to the JENVIS meibo scale. Grade 0= no dropout; grade 1= area of gland loss up to 33% of the total gland area; grade 2 = area of gland loss between 33 and 66%; grade 3 = area of gland loss of 67% or more.
Measured: One month (±7 days) after cataract surgery
Development or worsening of ocular discomfort symptoms.
Evaluation based on the ocular surface disease index (OSDI) questionnaire. Normal OSDI: 0-12; a score of 13 or more is suggestive of dry eye disease (DED) Mild DED = 13 - 22; Moderate DED = 23-32; Severe DED > 32
Measured: One month (±7 days) 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 posted3 Mar 2023
- Study start30 Mar 2022
- Primary completion30 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Giannaccare, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754437
- Sponsor's protocol ID
- CatMask
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2023
- Last updated
- 28 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Giannaccare G, Borselli M, Rossi C, Carnovale Scalzo G, Pellegrini M, Vaccaro S, Scalia G, Lionetti G, Mancini A, Bianchi P, Scorcia V. Noninvasive screening of ocular surface disease in otherwise healthy patients scheduled for cataract surgery. Eur J Ophthalmol. 2024 Sep;34(5):1475-1480. doi: 10.1177/11206721241228621. Epub 2024 Jan 30.
PubMed 38291650Giannaccare G, Rossi C, Borselli M, Carnovale Scalzo G, Scalia G, Pietropaolo R, Fratto B, Pellegrini M, Yu AC, Scorcia V. Outcomes of low-level light therapy before and after cataract surgery for the prophylaxis of postoperative dry eye: a prospective randomised double-masked controlled clinical trial. Br J Ophthalmol. 2024 Jul 23;108(8):1172-1176. doi: 10.1136/bjo-2023-323920.
PubMed 37890879
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Level Light Therapy Prior to Cataract Surgery: A Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05754437
- Acronym / sponsor ID
- CatMask
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Mater Domini, CatanzaroUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 3 Mar 2023 (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.
The goal of this clinical trial is to evaluate the effectiveness of Low Level Light Therapy (LLLT) in reducing the incidence or alleviating the severity of DED due to meibomian gland dysfunction in otherwise healthy patients undergoing cataract surgery.
Participants will be randomly assigned in a 1:1 ratio to either a treatment group or a control group.
The treatment group will receive LLLT one week before and one week after cataract surgery; the control group will not recieve LLLT at any time.
Researchers will compare the treatment and the control group to see if patients receiving LLLT present with reduced signs and symptoms of ocular surface dysfunction with respect to the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Level Light Therapy Group | Experimental | Device: Low Level Light TherapyPatients enrolled in the treatment group will undergo Low Level Light therapy using Meibomask (Espansione Marketing S.p.A., Bologna, Italy) for 15 minutes one week (±2 days) before surgery (T0) and one week (±2 days) after surgery (T1). |
| Control group | No intervention | –Patients enrolled in the control group will not receive Low Level Light therapy at any time. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy patients affected by senile cataract
- patients scheduled for phacoemulsification and intraocular lens implantation
Key exclusion criteria (9 listed)
- any other ocular comorbidity (e.g. glaucoma),
- chronic instillation of eye drops of any type
- previous ocular surgery or trauma to the addressed eye
- previous cataract surgery in the controlateral eye,
- active ocular infections
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 Therapylight-emitting diodes (LED), λ = 633 ± 10 nm; power of 100 mW/cm2, 15 minutes | Device | Low Level Light Therapy Group |
Primary outcome
Development or worsening of ocular surface abnormalities: tear meniscus height
Time frame: One week (±2 days) after cataract surgery
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Measurement expressed in millimeters.
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) FIRST
Time frame: One week (±2 days) after cataract surgery
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). NIKBUT FIRST: interval time between the last complete blinking and the first distortion the 22 concentric rings reflected on the corneal surface. Measurement expressed in seconds.
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) AVG
Time frame: One week (±2 days) after cataract surgery
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). NIKBUT AVG: average time of all tear film break-ups occurring in the measured period of up to 24.98 seconds (time limit set by the device's software). Measurement expressed in seconds.
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) CLASS
Time frame: One week (±2 days) after cataract surgery
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). NIKBUT CLASS: classification incorporated in the instrument: class 0 > 10 s (normal), class I 6 - 10 s, class II 3 - 6 s, class III < 3 s.Measurement expressed in seconds.
Development or worsening of ocular surface abnormalities: bulbar redness
Time frame: One week (±2 days) after cataract surgery
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). This parameter is expressed as as a ratio of vessels/free sclera and is automatically calculated by the instrument.
Development or worsening of ocular surface abnormalities: meibomian gland dropout
Time frame: One week (±2 days) after cataract surgery
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Dropout is calculated according to the JENVIS meibo scale. Grade 0= no dropout; grade 1= area of gland loss up to 33% of the total gland area; grade 2 = area of gland loss between 33 and 66%; grade 3 = area of gland loss of 67% or more
Development or worsening of ocular discomfort symptoms.
Time frame: One week (±2 days) after cataract surgery
Evaluation based on the ocular surface disease index (OSDI) questionnaire. Normal OSDI: 0-12; a score of 13 or more is suggestive of dry eye disease (DED) Mild DED = 13 - 22; Moderate DED = 23-32; Severe DED > 32
Development or worsening of ocular surface abnormalities: tear meniscus height
Time frame: One month (±7 days) after cataract surgery
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Measurement expressed in millimeters.
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) FIRST
Time frame: One month (±7 days) after cataract surgery
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). NIKBUT FIRST: interval time between the last complete blinking and the first distortion the 22 concentric rings reflected on the corneal surface. Measurement expressed in seconds.
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) AVG
Time frame: One month (±7 days) after cataract surgery
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). NIKBUT AVG: average time of all tear film break-ups occurring in the measured period of up to 24.98 seconds (time limit set by the device's software). Measurement expressed in seconds.
Development or worsening of ocular surface abnormalities: non-invasive keratograph break up time (NIKBUT) CLASS
Time frame: One month (±7 days) after cataract surgery
Evaluation based on slit lamp examination and Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). NIKBUT CLASS: classification incorporated in the instrument: class 0 > 10 s (normal), class I 6 - 10 s, class II 3 - 6 s, class III < 3 s.Measurement expressed in seconds.
Development or worsening of ocular surface abnormalities: bulbar redness
Time frame: One month (±7 days) after cataract surgery
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). This parameter is expressed as as a ratio of vessels/free sclera and is automatically calculated by the instrument.
Development or worsening of ocular surface abnormalities: meibomian gland dropout
Time frame: One month (±7 days) after cataract surgery
Evaluation based on Oculus Keratograph 5 M (K5 M; Oculus GmbH, Wetzlar, Germany). Dropout is calculated according to the JENVIS meibo scale. Grade 0= no dropout; grade 1= area of gland loss up to 33% of the total gland area; grade 2 = area of gland loss between 33 and 66%; grade 3 = area of gland loss of 67% or more.
Development or worsening of ocular discomfort symptoms.
Time frame: One month (±7 days) after cataract surgery
Evaluation based on the ocular surface disease index (OSDI) questionnaire. Normal OSDI: 0-12; a score of 13 or more is suggestive of dry eye disease (DED) Mild DED = 13 - 22; Moderate DED = 23-32; Severe DED > 32
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 28 Jan 2025.
- Derived from this study: PubMed 38291650Giannaccare G, Borselli M, Rossi C, Carnovale Scalzo G, Pellegrini M, Vaccaro S, Scalia G, Lionetti G, Mancini A, Bianchi P, Scorcia V. Noninvasive screening of ocular surface disease in otherwise healthy patients scheduled for cataract surgery. Eur J Ophthalmol. 2024 Sep;34(5):1475-1480. doi: 10.1177/11206721241228621. Epub 2024 Jan 30.
- Derived from this study: PubMed 37890879Giannaccare G, Rossi C, Borselli M, Carnovale Scalzo G, Scalia G, Pietropaolo R, Fratto B, Pellegrini M, Yu AC, Scorcia V. Outcomes of low-level light therapy before and after cataract surgery for the prophylaxis of postoperative dry eye: a prospective randomised double-masked controlled clinical trial. Br J Ophthalmol. 2024 Jul 23;108(8):1172-1176. doi: 10.1136/bjo-2023-323920.
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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, run by Azienda Ospedaliera Universitaria Mater Domini, Catanzaro at 1 site in Italy.
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 2 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: finished, as of the sponsor's last update on 28 Jan 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 Italy. 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?
Development or worsening of ocular surface abnormalities: tear meniscus height (time frame: One week (±2 days) after cataract surgery). The study lists 14 primary outcomes in all. 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 NCT05754437, which also lists 2 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 28 Jan 2025.