Efficacy of Low-Level Light Therapy in Reducing Dry Eye in Patients Undergoing Cataract Surgery
NCT ID: NCT05754437
Last Updated: 2025-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2022-03-30
2023-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Low Level Light Therapy Group
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).
Low Level Light Therapy
light-emitting diodes (LED), λ = 633 ± 10 nm; power of 100 mW/cm2, 15 minutes
Control group
Patients enrolled in the control group will not receive Low Level Light therapy at any time.
No interventions assigned to this group
Interventions
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Low Level Light Therapy
light-emitting diodes (LED), λ = 633 ± 10 nm; power of 100 mW/cm2, 15 minutes
Eligibility Criteria
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Inclusion Criteria
* patients scheduled for phacoemulsification and intraocular lens implantation
Exclusion Criteria
* 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)
* autoimmune diseases (e.g. Sjögren syndrome)
* intraoperative complications (e.g. capsular bag rupture requiring vitrectomy, suprachoroidal hemorrhage)
* postoperative complications (e.g. endophthalmitis, vitritis)
45 Years
ALL
No
Sponsors
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Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
OTHER
Responsible Party
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Giuseppe Giannaccare
Professor
Locations
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Department of Ophthalmology, University Magna Graecia of Catanzaro
Catanzaro, , Italy
Countries
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References
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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.
Giannaccare 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.
Other Identifiers
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CatMask
Identifier Type: -
Identifier Source: org_study_id
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