Clinical trial NCT03452969: Visual Outcomes of a Segmental Refractive Multifocal Intraocular Lens
Official title: Visual Outcomes After Implantation of a Segmental Refractive Multifocal Intraocular Lens Following Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Acuity
Keywords: visual outcomes
mulitfocal intraocular lens
patient satisfaction
spectacle independence
contrast sensitivity
Lead sponsor: University Clinic Frankfurt
Sponsor class: OTHER
Collaborators: name: Oculentis GmbH
First posted: 2018-03-02
Enrollment: 25
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received bilateral cataract surgery with the implantation of a segmental refractive multifocal intraocular lens

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.

Eligibility criteria: 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

Primary outcomes:
measure: Best corrected visual acuity at far distance
timeFrame: Measured 3 month after lens surgery
Secondary outcomes:
measure: Best corrected visual acuity at intermediate distance
timeFrame: Measured 3 month after lens surgery
measure: Best corrected visual acuity at near distance
timeFrame: Measured 3 month after lens surgery
measure: Uncorrected visual acuity at far distance
timeFrame: Measured 3 month after lens surgery
measure: Uncorrected visual acuity at intermediate distance
timeFrame: Measured 3 month after lens surgery
measure: Uncorrected visual acuity at near distance
timeFrame: Measured 3 month after lens surgery
measure: Binocular contrast sensitivity (CS) under photopic, mesopic, and mesopic with glare lighting conditions
timeFrame: Measured 3 month after lens surgery
measure: Defocus curve testing
timeFrame: Measured 3 month after lens surgery
measure: Radner reading skills
timeFrame: Measured 3 month after lens surgery
measure: Optical quality questionnaire
timeFrame: Measured 3 month after lens surgery
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Department of ophthalmology University clinic Frankfurt
state: Hessen
Study officials:
affiliation: Goethe University Clinic Frankfurt
name: Thomas Kohnen, Professor
role: PRINCIPAL_INVESTIGATOR
References: