A Pilot Study Investigating the Impact of Different IOL Designs on Subjective 2D and 3D Image Quality

The WHO, states that age related cataracts account for 51 percent of worldwide blindness and affect about 20 million people. Surgery with intraocular lens (IOL) implantation is the first line treatment for cataracts, thus there is an on going effort to improve IOL design and performance.

It is planned to compare three different IOL designs in a psychophysical test setting. Most IOL testing is done in 2D scenarios such as Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity or contrast sensitivity testing. The use of 3D scenario would allow testing a more real-life situation.

As various downsides of different IOL designs have been reported, testing of IOLs before surgical implantation is a promising approach to maximise patient satisfaction. Known deficiencies include amongst others reduced contrast sensitivity or light intensity.

To test three different IOL designs, it is planned to have 2D healthy young subjects look through a stable, table mounted spectacle frame, in which the different IOLs can be inserted. This allows for subjective testing of IOL's in a 2D and 3D scenario.

Study Overview

• Status: Completed
• Conditions: Visual Acuity; Lenses; Intraocular Sensitivity
• Intervention / Treatment: Drug: Cyclopentolatehydrochloride 0,5% eye drops

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women aged between 18 and 35 years
• Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
• Normal ophthalmic findings
• Refractive spherical error between between -1 and +1 diopters, refractive cylindrical error between -0,25 and +0,25 diopters
• Dominant eye : right eye ( used as study eye)

Exclusion Criteria:

• Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
• Symptoms of a clinically relevant illness in the 3 weeks before the first study day

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 30 healthy male and female subjects; 30 healthy male and female subjects , age 18-35 years	Drug: Cyclopentolatehydrochloride 0,5% eye drops; 1 drop in study eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Acuity measured by Early Treatment of Diabetic Retinopathy Study Chart	1 study day

Secondary Outcome Measures

Outcome Measure	Time Frame
Contrast Sensitivity measured by Pelli-Robson Contrast Sensitivity Chart	1 study day

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Doreen Schmidl, MD, PhD, Department of Clinical Pharmacology, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: February 24, 2015
• First Submitted That Met QC Criteria: April 1, 2015
• First Posted (Estimate): April 7, 2015

Study Record Updates

• Last Update Posted (Estimate): April 8, 2015
• Last Update Submitted That Met QC Criteria: April 7, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: IOL
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: OPHT-011214