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

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Spherical Aberrations; Intraocular Lenses; Depth of Focus
• Intervention / Treatment: Device: AMO Sensar AR40e; Device: AMO Tecnis ZA9003

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Dept. of Ophthalmology, Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypermetropic, spherical IOL; AMO Sensar AR40e	Device: AMO Sensar AR40e
Experimental: Hypermetropic, aspheric IOL; AMO Tecnis ZA9003	Device: AMO Tecnis ZA9003
Active Comparator: Emmetropic, spherical IOL; AMO Sensar AR40e	Device: AMO Sensar AR40e
Active Comparator: Emmetropic, aspheric IOL; AMO Tecnis ZA9003	Device: AMO Tecnis ZA9003

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Distance-corrected intermediate visual acuity	3 month postop

Secondary Outcome Measures

Outcome Measure	Time Frame
Distance-corrected near visual acuity	3 month postop
Uncorrected distance visual acuity	3 month postop
Corrected distance visual acuity	3 month postop
Uncorrected near visual acuity	3 month postop
Corrected near visual acuity	3 month postop
Pseudoaccomodation	3 month postop
Photopic contrast sensitivity	3 month postop
Mesopic contrast sensitivity	3 month postop
Spherical aberrations	3 month postop
High order aberrations	3 month postop

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Navid Ardjomand, MD, Dept. of Ophthalmology, Medical University of Graz

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 26, 2016

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (Estimate): November 26, 2013

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: SIOLvsAIOL