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

NCT02409641 | Completed

• 1 other identifier: OPHT-011214
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lenses; Intraocular Sensitivity; Visual Acuity

Keywords

IOL

Outcome Measures

Primary Outcomes (1)

• Visual Acuity measured by Early Treatment of Diabetic Retinopathy Study Chart

  1 study day

Secondary Outcomes (1)

• Contrast Sensitivity measured by Pelli-Robson Contrast Sensitivity Chart

  1 study day

Study Arms (1)

30 healthy male and female subjects

EXPERIMENTAL

30 healthy male and female subjects , age 18-35 years

Drug: Cyclopentolatehydrochloride 0,5% eye drops

Interventions

Cyclopentolatehydrochloride 0,5% eye drops DRUG

1 drop in study eye

30 healthy male and female subjects

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria

Location

Study Officials

• Doreen Schmidl, MD, PhD

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv.-Doz. Dr.

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: April 7, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

AU (1)