Comparison of Premium Monovision and Bilateral Implantation of Trifocal Diffractive Intraocular Lenses

NCT ID: NCT05494177

Last Updated: 2023-06-18

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-03-01

Brief Summary

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Primary objective of this study is to compare two presbyopia correction surgical techniques, specificaly premium monovision, in which the dominant eye is corrected with an extended depth of field intraocular lens and the non-dominant eye with a trifocal diffractive intraocular lens, and the bilateral implantation of trifocal diffractive intraocular lenses.

Detailed Description

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Two study groups will be formed. The first group will include patients who undergone premium monovision and the second will include patients who undergone bilateral implantation of trifocal diffractive intraocular lenses. Patients who have undergone one of the aforementioned categories of presbyopia correction surgery will be selected in order to compare the effectiveness of these techniques by evaluating uncorrected near, intermediate and distant visual acuity, uncorrected Critical Print Size (CPS) in near and intermediate distance, dysphotopic phenomena (glare, halos) through a 4-level severity scale by patients, contrast sensitivity, the need of use glasses for all distances or separately for activities requiring near or distant vision as well as the degree of subjective satisfaction of patient via interview (NEI-VFQ 25). The purpose of measuring these parameters is to calculate, through a mathematical model, the relative effectiveness of each method.

Conditions

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Presbyopia Refractive Errors Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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).

Intervention Type DIAGNOSTIC_TEST

Contrast sensitivity

Contrast sensitivity is assessed with the Pelli-Robson test.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of cataract with stage 2 according to the Lens Opacities Classification System III (LOCS-3) grading scale
* Age\>45 years

Exclusion Criteria

* Disability to understand the Greek language and respond to the interview
* Fundus or corneal diseases
* Glaucoma
* Previous intraocular surgery
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Democritus University of Thrace

OTHER

Sponsor Role lead

Responsible Party

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Georgios Labiris

Professor (Associate) of Democritus University of Thrace

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Greece

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.

Reference Type DERIVED
PMID: 37847127 (View on PubMed)

Other Identifiers

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ES13/Th7/07-07-2022

Identifier Type: -

Identifier Source: org_study_id

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