Visual Outcomes of a Segmental Refractive Multifocal Intraocular Lens

Study Overview
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Brief Summary
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To evaluate visual outcomes of a segmental refractive multifocal intraocular lens (IOL) after cataract surgery.

Detailed Description
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Purpose: This prospective, nonrandomized noncomparative case series investigates the visual performance after bilateral implantation of a segmental refractive multifocal intraocular lenses (IOL) after cataract surgery and was performed at the department of Ophthalmology, Goethe University, Frankfurt, Germany. Methods: Fifty eyes (25 patients) were included. Inclusion criteria were bilateral cataract, age > 45 years, corneal astigmatism ≤ 0.75 D postoperatively, pupil size 3 to 6 mm (mesopic), and center shift < 1 mm (Pentacam). Exclusion criteria were previous ocular surgeries, amblyopia or potential postoperative distance-corrected visual acuity (DCVA) < 0.3 logMAR, Intervention or Observation: Uncorrected (UCVA) and DCVA in 4 m, 80 cm, 40 cm; contrast sensitivity (CS) under photopic and mesopic conditions; reading skills (Radner Reading Charts); defocus curve, questionnaire on optical quality (OQ) and spectacle independence were assessed after 3 months. Main Outcome Measures: At 3 months postoperatively, UCVA and DCVA in 4 m, 80 cm, 40 cm (logMAR); defocus curves; CS; reading skills; and OQ questionnaire results.

Official Title
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Visual Outcomes After Implantation of a Segmental Refractive Multifocal Intraocular Lens Following Cataract Surgery

Conditions
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Visual Acuity

Intervention / Treatment
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* Other: Implantation of multifocal intraocular lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: bilateral cataract age > 45 years corneal astigmatism ≤ 0.75 D postoperatively pupil size 3 to 6 mm (mesopic) center shift < 1 mm Exclusion Criteria: previous ocular surgeries amblyopia potential postoperative distance-corrected visual acuity (DCVA) < 0.3 logMAR

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Implantation of multifocal intraocular lens|Procedure/Surgery: Bilateral implantation of a segmental refractive multifocal intraocular lens (MIOL) following cataract surgery.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity at far distance | Monocular and binocular corrected visual acuity at far distance measured in logMAR 3 month after lens surgery | Measured 3 month after lens surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity at intermediate distance | Monocular and binocular corrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery | Measured 3 month after lens surgery | 
| Best corrected visual acuity at near distance | Monocular and binocular best corrected visual acuity at near distance measured in logMAR 3 month after lens surgery | Measured 3 month after lens surgery | 
| Uncorrected visual acuity at far distance | Monocular and binocular uncorrected visual acuity at far distance measured in logMAR 3 month after lens surgery | Measured 3 month after lens surgery | 
| Uncorrected visual acuity at intermediate distance | Monocular and binocular uncorrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery | Measured 3 month after lens surgery | 
| Uncorrected visual acuity at near distance | Monocular and binocular uncorrected visual acuity at near distance measured in logMAR 3 month after lens surgery | Measured 3 month after lens surgery | 
| Binocular contrast sensitivity (CS) under photopic, mesopic, and mesopic with glare lighting conditions | Binocular contrast sensitivity (CS) was measured with the Functional Acuity Contrast Test (FACT) chart in the Optec 6500 Vision Tester (Stereo Optical Co., Chicago, IL) under binocular photopic (85 cd/m²), mesopic (3 cd/m²), and photopic and mesopic with glare conditions at a spatial frequency of 6 cycles per degree (cpd) (threshold range 0.78-2.26). | Measured 3 month after lens surgery | 
| Defocus curve testing | Defocus curve (monocular and binocular) was tested from -5.0 D to +2.0 D in 0.5 D steps under photopic lighting conditions (ETDRS). | Measured 3 month after lens surgery | 
| Radner reading skills | Binocular distance-corrected reading acuity (40 cm) was investigated in LogRAD (Reading Acuity Determination) using reading charts (Radner Reading Charts). | Measured 3 month after lens surgery | 
| Optical quality questionnaire | Quality of vision questionnaire (visual analogue scale (VAS) 0 (perfect / no symptoms) to 100 (extremely poor / maximum symptom intensity)) asking for evaluation of glare, halos, starbursts, blurred vision, and ghosting under photopic, mesopic and scotopic light conditions, if they wear any spectacles, and to evaluate their total quality of vision. | Measured 3 month after lens surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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visual outcomes, mulitfocal intraocular lens, patient satisfaction, spectacle independence, contrast sensitivity