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Completed

NCT Number: NCT01995630

Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients

The purpose of this study is to evaluate differences in the depth of focus after implantation of a spherical or aspheric IOL in hypermetropic and emmetropic patients. After implantation of a spherical IOL hypermetropic patients may achieve a better depth of focus compared to emmetropic patients due to a larger amount of spherical aberrations.

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Key information

Conditions

Cataract Depth of Focus Eye Diseases Intraocular Lenses Lens Diseases Spherical Aberrations

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Ophthalmology, Medical University of Graz

Graz, 8036, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Cataract
  • Dioptric power of IOL >22.0 D in hypermetropic patients and 18.0-22.0 D in emmetropic patients, respectively

Exclusion criteria

  • Uveitis, pathology of the retina or the optic nerve
  • Corneal scarring or irregularities
  • Astigmatism >1.5 D
  • Amblyopia
  • Perioperative complications
  • Postoperative refractive error >2.0 D of spherical equivalent
  • Postoperative DCVA <0.8 (ETDRS)

Treatment and study plan

AMO Tecnis ZA9003

Device

AMO Sensar AR40e

Device

Primary outcomes

  1. Distance-corrected intermediate visual acuity

    Time frame: 3 month postop

Secondary outcomes

  1. Distance-corrected near visual acuity

    Time frame: 3 month postop

  2. Uncorrected distance visual acuity

    Time frame: 3 month postop

  3. Corrected distance visual acuity

    Time frame: 3 month postop

  4. Uncorrected near visual acuity

    Time frame: 3 month postop

  5. Corrected near visual acuity

    Time frame: 3 month postop

  6. Pseudoaccomodation

    Time frame: 3 month postop

  7. Photopic contrast sensitivity

    Time frame: 3 month postop

  8. Mesopic contrast sensitivity

    Time frame: 3 month postop

  9. Spherical aberrations

    Time frame: 3 month postop

  10. High order aberrations

    Time frame: 3 month postop

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients: A Randomized Clinical Trial

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 26, 2013
Registry last updated
Jun 28, 2017

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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