Visual Acuity
Conditions
Keywords
visual outcomes, mulitfocal intraocular lens, patient satisfaction, spectacle independence, contrast sensitivity
Brief summary
To evaluate visual outcomes of a segmental refractive multifocal intraocular lens (IOL) after cataract surgery.
Detailed description
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.
Interventions
OTHERImplantation of multifocal intraocular lens
Procedure/Surgery: Bilateral implantation of a segmental refractive multifocal intraocular lens (MIOL) following cataract surgery.
Sponsors
Oculentis GmbH
University Clinic Frankfurt
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity at far distance | Measured 3 month after lens surgery | Monocular and binocular corrected visual acuity at far distance measured in logMAR 3 month after lens surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity at near distance | Measured 3 month after lens surgery | Monocular and binocular best corrected visual acuity at near distance measured in logMAR 3 month after lens surgery |
| Uncorrected visual acuity at far distance | Measured 3 month after lens surgery | Monocular and binocular uncorrected visual acuity at far distance measured in logMAR 3 month after lens surgery |
| Uncorrected visual acuity at intermediate distance | Measured 3 month after lens surgery | Monocular and binocular uncorrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery |
| Uncorrected visual acuity at near distance | Measured 3 month after lens surgery | Monocular and binocular uncorrected visual acuity at near distance measured in logMAR 3 month after lens surgery |
| Best corrected visual acuity at intermediate distance | Measured 3 month after lens surgery | Monocular and binocular corrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery |
| Defocus curve testing | Measured 3 month after lens surgery | 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). |
| Radner reading skills | Measured 3 month after lens surgery | Binocular distance-corrected reading acuity (40 cm) was investigated in LogRAD (Reading Acuity Determination) using reading charts (Radner Reading Charts). |
| Optical quality questionnaire | Measured 3 month after lens surgery | 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. |
| Binocular contrast sensitivity (CS) under photopic, mesopic, and mesopic with glare lighting conditions | Measured 3 month after lens surgery | 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). |
Countries
Germany
Outcome results
None listed