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

Visual Acuity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409641
• Other study ID #: OPHT-011214
• Status: Completed
• Phase: N/A
• First received: February 24, 2015
• Last updated: April 7, 2015
• Start date: February 2015
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Intraocular Sensitivity
• Lenses
• Visual Acuity

Intervention

Drug:
• Cyclopentolatehydrochloride 0,5% eye drops
1 drop in study eye

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity measured by Early Treatment of Diabetic Retinopathy Study Chart		1 study day	No
Secondary	Contrast Sensitivity measured by Pelli-Robson Contrast Sensitivity Chart		1 study day	No