Expanding Visual Horizons: Comparative Outcomes of a Novel Extended Depth-of-Focus IOL Versus Enhanced and Standard Monofocal IOLs
Conditions: Age-related Cataract
Sponsor: Sakarya Yenikent State Hospital

Cover Page
Official Title: Expanding Visual Horizons: Comparative Outcomes of a Novel Extended Depth-
of-Focus IOL Versus Enhanced and Standard Monofocal IOLs
NCT Number: NCT not assigned
Document Date: 2024-02-06
Document Type: Study Protocol with Statistical Analysis Plan (SAP)
Ethics Committee: Sakarya University Faculty of Medicine Non-Interventional Ethics Com-
mittee (Approval 2022/294)
Site: Sakarya Education and Research Hospital, Sakarya, Turkey
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Study Protocol
Background and Rationale
Patients undergoing cataract surgery increasingly expect functional vision at distance, interme-
diate, and near without disturbing photic phenomena. Standard monofocal IOLs offer excellent
distance acuity but limited intermediate and near vision. Enhanced monofocal and extended depth-
of-focus (EDOF) lenses aim to broaden the range of clear vision while minimizing dysphotopsia.
This study compares outcomes across these IOL categories.
Objectives
Primary Objective: To compare binocular uncorrected distance, intermediate, and near visual
acuity and patient satisfaction at 6 months among monofocal, enhanced monofocal, and EDOF
IOLs.
Secondary Objectives: To compare monocular and binocular corrected acuities, refraction,
defocus curve performance, and halo/glare symptoms among the three IOL groups.
Study Design
Consecutive, comparative, retrospective case series of patients undergoing bilateral phacoemulsi-
fication with implantation of the same IOL model in both eyes.
Study Period
June 2019 to January 2024. Primary completion in 2024.
Study Population
Adults aged 45–75 years with age-related cataract undergoing bilateral cataract surgery.
Inclusion Criteria
• Age-related cataract in both eyes.
• Eligible for bilateral IOL implantation.
• Willingness to complete follow-up.
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Exclusion Criteria
• Preoperative corneal astigmatism ¿ 1.0 D.
• Axial length ¡ 21 mm or ¿ 26 mm.
• Prior intraocular or corneal surgery.
• Ocular comorbidities affecting vision (severe dry eye, amblyopia, ocular surface disease,
corneal pathology, retinal diseases, uveitis, glaucoma, pseudoexfoliation, pterygium).
• Intraoperative or postoperative complications, or failure to complete 6-month follow-up.
Interventions / Exposures
Patients received one of the following IOLs in both eyes:
• Monofocal: Tecnis ZCB00 (Johnson & Johnson Vision)
• Enhanced monofocal: Tecnis Eyhance ICB00 (Johnson & Johnson Vision)
• EDOF: Asqelio EDOF ETLIO130C (AST Products)
Surgical Technique and Postoperative Care
Standard phacoemulsification using manufacturer-recommended injector systems. IOL power se-
lected to target approximately -0.25 D (first myopic-leaning power). Postoperative regimen: top-
ical 0.5% moxifloxacin + 0.1% dexamethasone five times daily for one week, tapered over three
weeks. Follow-up at 1 day, 1 week, 1 month, 3 months, and 6 months.
Assessments and Outcome Measures
At 6 months, visual acuity measured at distance (6 m), intermediate (66 cm), and near (40 cm)
under photopic conditions, converted to logMAR. Refraction (manifest and objective), binocular
defocus curves (+1.00 D to -2.50 D in 0.50 D steps), and patient questionnaires on halos/glare and
spectacle independence were recorded.
Primary Outcomes (6 months):
• Binocular UDVA, UIVA, UNVA (logMAR).
• Patient satisfaction scores for distance, intermediate, and near spectacle-free vision (0–10
scale).
Secondary Outcomes (6 months):
• Monocular UDVA, UIVA, UNVA (logMAR).
• Monocular and binocular CDVA, CIVA, CNVA.
• Manifest and objective spherical equivalent refraction.
• Binocular defocus curve performance.
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• Halo and glare scores (NEI-RQL-42 items 17 and 38; 0–100 scale).
Sample Size
A post hoc power analysis (one-way ANOVA; Cohen’s f = 0.25, alpha 0.05, three groups, n = 197)
yielded power of 0.96.
Ethics
The study adhered to the Declaration of Helsinki and was approved by the Sakarya University Fac-
ulty of Medicine Non-Interventional Ethics Committee (Approval 2022/294). Written informed
consent was obtained.
Data Sharing
Individual participant data will not be shared.
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Statistical Analysis Plan (SAP)
Analysis Population
All eligible patients completing 6-month follow-up were included. Both eyes contributed to out-
comes; inter-eye correlation was addressed using GEE for selected analyses.
Descriptive Statistics
Continuous variables summarized as mean ±SD. Categorical variables summarized as counts and
percentages.
Normality Testing
Kolmogorov–Smirnov and Shapiro–Wilk tests assessed normality.
Comparative Analyses
• Kruskal–Wallis tests with Dunn–Bonferroni post hoc comparisons for non-normally dis-
tributed continuous outcomes.
• One-way ANOVA with Tukey HSD for key binocular outcomes when appropriate.
• Chi-square or Fisher’s exact tests for categorical variables.
• GEE model with exchangeable correlation structure for binocular UIVA to account for within-
subject correlation.
Significance Threshold
Two-tailed p ¡ 0.05 considered statistically significant.
Software
IBM SPSS Statistics version 24.0 (IBM Corp., Armonk, NY, USA).
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