Comparison of Premium Monovision and Bilateral Implantation of Trifocal Diffractive Intraocular Lenses
NCT ID: NCT05494177
Last Updated: 2023-06-18
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
100 participants
OBSERVATIONAL
2022-08-01
2023-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Premium monovision
Patients will undergo to implantation of an extended depth of field intraocular lens in the dominant eye and a trifocal diffractive intraocular lens in the non-dominant eye.
bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS
All participants will be assessed on the following clinical indexes:
1. Binocular uncorrected distant visual acuity (bUDVA) at four meters distance
2. Binocular uncorrected intermediate reading acuity (bUIRA) at 60 cm
3. Binocular uncorrected near reading acuity (bUNVA) at 40 cm
4. Binocular uncorrected intermediate Critical Print Size (bUICPS) at 60 cm
5. Binocular uncorrected near Critical Print Size (bUNCPS) at 40 cm
All the above parameters are obtained using the Democritus Digital Acuity \& Reading Test (DDART).
Contrast sensitivity
Contrast sensitivity is assessed with the Pelli-Robson test.
Bilateral trifocal diffractive implantation
Patients will undergo to bilateral implantation of trifocal diffractive lenses.
bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS
All participants will be assessed on the following clinical indexes:
1. Binocular uncorrected distant visual acuity (bUDVA) at four meters distance
2. Binocular uncorrected intermediate reading acuity (bUIRA) at 60 cm
3. Binocular uncorrected near reading acuity (bUNVA) at 40 cm
4. Binocular uncorrected intermediate Critical Print Size (bUICPS) at 60 cm
5. Binocular uncorrected near Critical Print Size (bUNCPS) at 40 cm
All the above parameters are obtained using the Democritus Digital Acuity \& Reading Test (DDART).
Contrast sensitivity
Contrast sensitivity is assessed with the Pelli-Robson test.
Interventions
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bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS
All participants will be assessed on the following clinical indexes:
1. Binocular uncorrected distant visual acuity (bUDVA) at four meters distance
2. Binocular uncorrected intermediate reading acuity (bUIRA) at 60 cm
3. Binocular uncorrected near reading acuity (bUNVA) at 40 cm
4. Binocular uncorrected intermediate Critical Print Size (bUICPS) at 60 cm
5. Binocular uncorrected near Critical Print Size (bUNCPS) at 40 cm
All the above parameters are obtained using the Democritus Digital Acuity \& Reading Test (DDART).
Contrast sensitivity
Contrast sensitivity is assessed with the Pelli-Robson test.
Eligibility Criteria
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Inclusion Criteria
* Age\>45 years
Exclusion Criteria
* Fundus or corneal diseases
* Glaucoma
* Previous intraocular surgery
45 Years
85 Years
ALL
No
Sponsors
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Democritus University of Thrace
OTHER
Responsible Party
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Georgios Labiris
Professor (Associate) of Democritus University of Thrace
Principal Investigators
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Georgios Labiris, MD, PhD
Role: STUDY_CHAIR
Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
Locations
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Department of Ophthalmology, University Hospital of Alexandroupolis
Alexandroupoli, Evros, Greece
Countries
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References
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Labiris G, Panagis C, Ntonti P, Konstantinidis A, Bakirtzis M. Mix-and-match vs bilateral trifocal and bilateral EDOF intraocular lens implantation: the spline curve battle. J Cataract Refract Surg. 2024 Feb 1;50(2):167-173. doi: 10.1097/j.jcrs.0000000000001336.
Other Identifiers
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ES13/Th7/07-07-2022
Identifier Type: -
Identifier Source: org_study_id
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