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Completed

NCT Number: NCT03452969

Visual Outcomes of a Segmental Refractive Multifocal Intraocular Lens

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

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Key information

Conditions

Visual Acuity Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of ophthalmology University clinic Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation of multifocal intraocular lens

Other

Procedure/Surgery:

Bilateral implantation of a segmental refractive multifocal intraocular lens (MIOL) following cataract surgery.

Primary outcomes

  1. 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

  1. Best corrected visual acuity at intermediate distance

    Time frame: Measured 3 month after lens surgery

    Monocular and binocular corrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery

  2. Best corrected visual acuity at near distance

    Time frame: Measured 3 month after lens surgery

    Monocular and binocular best corrected visual acuity at near distance measured in logMAR 3 month after lens surgery

  3. Uncorrected visual acuity at far distance

    Time frame: Measured 3 month after lens surgery

    Monocular and binocular uncorrected visual acuity at far distance measured in logMAR 3 month after lens surgery

  4. Uncorrected visual acuity at intermediate distance

    Time frame: Measured 3 month after lens surgery

    Monocular and binocular uncorrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery

  5. Uncorrected visual acuity at near distance

    Time frame: Measured 3 month after lens surgery

    Monocular and binocular uncorrected visual acuity at near distance measured in logMAR 3 month after lens surgery

  6. Binocular contrast sensitivity (CS) under photopic, mesopic, and mesopic with glare lighting conditions

    Time frame: 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).

  7. Defocus curve testing

    Time frame: 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).

  8. Radner reading skills

    Time frame: 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).

  9. Optical quality questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Clinic Frankfurt

Other

Collaborators

  • Oculentis GmbH

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 2, 2018
Registry last updated
Oct 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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