The Purpose is to Evaluate Visual Acuity for Distance, Intermediate and Near and Additionally Contrast Sensitivity at 25% and 10% of Illumination After Implantation of Trifocal IOL, Extended Range of Vision IOL, Bifocal IOL With Low Addition and Monofocal IOL
IOL
Visual Outcome After Implantation of Three Different Presbyopia-correcting IOLs and Monofocal IOL
1 other identifier
interventional
131
1 country
1
Brief Summary
The objective of this study was to evaluate the effect of intraocular lens (IOL) selection on visual acuity and refractive outcomes, to assess the impact of IOL type on postoperative contrast sensitivity, and to investigate whether IOL choice influences the induction and dynamics of higher-order ocular aberrations following cataract surgery/refractive lens exchange surgery in hyperopic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedFirst Submitted
Initial submission to the registry
May 28, 2025
CompletedFirst Posted
Study publicly available on registry
June 6, 2025
CompletedJune 12, 2025
June 1, 2025
2.8 years
May 28, 2025
June 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Uncorrected and Corrected Visual Acuity changes for distance, intermediate, and near in all four groups during the follow up
To evaluate differences in uncorrected distance visual acuity (UDVA); corrected distance visual acuity (CDVA); uncorrected intermediate visual acuity (UIVA); corrected intermediate visual acuity (CIVA); uncorrected near visual acuity (UNVA), and corrected near visual acuity (CNVA) following the implantation of three types of multifocal intraocular lenses (IOLs) and one monofocal IOL (serving as the control group), the mean values of visual acuity parameters were compared across all four IOL groups at each postoperative measurement time point.
12 months
Higher-order aberration changes in all four groups during the follow up
The values of coma aberration were defined as the square root (Root mean square - RMS) of the sum of the squares of the coefficients Z-13 and Z13, while the amount of spherical aberration is defined as the value of the Z04 coefficient.
12 months
Contrast sensitivity changes at 25% and 10% illumination in all four groups during the follow up
Contrast sensitivity was measured monocularly on a computerized screen in a lighted room at 85cd/m2. Sloan letters were projected onto the screen at 0.1 LogMAR, at the illuminances of 25% and 10%. Visual acuity was recorded at logMAR where the patient was able to read all letters.
12 months
Study Arms (4)
Group 1 - TRIFOCAL IOL
EXPERIMENTALThe total number of patients who underwent cataract surgery or refractive lens exchange surgery with trifocal IOL implantation was thirty of the mean (±sd; range) age 57.23 (±6.1, 45-69).
Group 2 - EROV
EXPERIMENTALThe total number of patients who underwent cataract surgery or refractive lens exchange surgery with extended range of vision IOL implantation was thirty-five of the mean (±sd; range) age 59.12 (±5.4, 45-71).
Group 3 - BIFOCAL IOL
EXPERIMENTALThe total number of patients who underwent cataract surgery or refractive lens exchange surgery with bifocal IOL with low addition implantation was thirty-four of the mean (±sd; range) age 59.94 (±9.1, 45-71).
Group 4 - MONOFOCAL IOL
ACTIVE COMPARATORThe total number of patients who underwent cataract surgery or refractive lens exchange surgery with monofocal IOL implantation was thirty-two of the mean (±sd; range) age 61.33 (±8.7, 45-74), were recruited as controls.
Interventions
Cataract surgery or refractive lens exchange surgery was performed with standard phacoemulsification procedure using micro coaxial surgical technique. After superior clear corneal incision, anterior capsulorexis and lens phacoemulsification, the IOL was implanted into the capsular bag using an injector in all cases. Ophthalmic Viscosurgical Device (OVD) was completely removed by irrigation and aspiration. All incisions were self-closing.
1-piece aspheric hydrophobic presbyopia-correcting intraocular lens, trifocal
1-piece aspheric hydrophobic presbyopia-correcting intraocular lens, extended range of vision (EROV)
1-piece aspheric hydrophobic presbyopia-correcting intraocular lens, bifocal with low addition
Control lens: 1-piece aspheric hydrophobic monofocal aspheric IOL
Eligibility Criteria
You may qualify if:
- Age of ≥ 45 years
- Hyperopic correction ranging from +0.50 D to +5.00 D, and astigmatism of up to +1.00 D
- Best corrected visual acuity of ≥0.05 LogMAR
You may not qualify if:
- Previously performed eye surgical procedures or eye injuries
- Glaucoma
- Fuchs' endothelial dystrophy or other corneal diseases (corneal degeneration and dystrophy)
- Zonular weakness or subluxated lens
- Systemic autoimmune and rheumatic disease
- Insulin dependent diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Univestity Eye Hospital Svjetlost
Zagreb, 10000, Croatia
Related Publications (1)
Jagic M, Bohac M, Biscevic A, Suic SP, Patel S. Comparing Clinical Outcomes of Various Presbyopia-Correcting Intraocular Lenses Using a Novel Composite Method for the Analysis and Reporting of Uncorrected Distance, Intermediate, and Near Visual Acuities. Ophthalmol Ther. 2025 Nov 14. doi: 10.1007/s40123-025-01262-4. Online ahead of print.
PMID: 41239160DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Principal Investigator
Study Record Dates
First Submitted
May 28, 2025
First Posted
June 6, 2025
Study Start
January 1, 2018
Primary Completion
October 31, 2020
Study Completion
March 30, 2022
Last Updated
June 12, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share