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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Lenses Intraocular Sensitivity Visual Acuity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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30 healthy male and female subjects

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

Group Type EXPERIMENTAL

Cyclopentolatehydrochloride 0,5% eye drops

Intervention Type DRUG

1 drop in study eye

Interventions

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Cyclopentolatehydrochloride 0,5% eye drops

1 drop in study eye

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes