Visual Outcomes After Implantation of a Segmental Refractive Multifocal Intraocular Lens Following Cataract Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Best corrected visual acuity at far distance
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Best corrected visual acuity at far distance
Time Frame: Measured 3 month after lens surgery
Monocular and binocular corrected visual acuity at far distance measured in logMAR 3 month after lens surgery
Secondary Outcomes
- Best corrected visual acuity at intermediate distance(Measured 3 month after lens surgery)
- Best corrected visual acuity at near distance(Measured 3 month after lens surgery)
- Uncorrected visual acuity at intermediate distance(Measured 3 month after lens surgery)
- Uncorrected visual acuity at far distance(Measured 3 month after lens surgery)
- Uncorrected visual acuity at near distance(Measured 3 month after lens surgery)
- Binocular contrast sensitivity (CS) under photopic, mesopic, and mesopic with glare lighting conditions(Measured 3 month after lens surgery)
- Defocus curve testing(Measured 3 month after lens surgery)
- Optical quality questionnaire(Measured 3 month after lens surgery)
- Radner reading skills(Measured 3 month after lens surgery)
Investigators
Myriam Böhm, MD
Professor Dr. med. Thomas Kohnen
University Clinic Frankfurt