A Pilot Study Simulating Multifocal Intraocular Lenses in Healthy Subjects

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01873781

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Age related cataracts are responsible for about 51 percent of blindness worldwide and according to the WHO affect about 20 million people, according to the WH . As cataract surgery is firstline treatment in the western world, there is a constant attempt to improve artificial intraocular lenes (IOL).

As for this study, the investigators seek to compare four different IOL designs in in a psychophysiological setting, allowing to assess the impact of these IOLs on vision and psychological processing of visual information.

As these IOLs also have downsides, such as reduced light intensity or image alterations, the subjective preference and overall impression shall be investigated. The healthy subjects look through a stable spectacle frame mounted onto a table, which enables the investigator to insert the different IOLs. This would allow subjective testing of IOLs before surgery.

Condition or Disease	Intervention/Treatment	Phase
Lenses, Intraocular Contrast Sensitivity Visual Acuity	Drug: Cyclopentolatehydrochloride

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
30 healthy male and female subjects 30 healthy male and female subjects aged 18-35	Drug: Cyclopentolatehydrochloride Cyclopentolatehydrochloride 0.5% (Thilo, Alcon, Vienna), dose: 1 drop for study eye

Arm

Intervention/Treatment

30 healthy male and female subjects

30 healthy male and female subjects aged 18-35

Drug: Cyclopentolatehydrochloride

Cyclopentolatehydrochloride 0.5% (Thilo, Alcon, Vienna), dose: 1 drop for study eye

Outcome Measures

Primary Outcome Measures

Eearly Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score [1 study day]
To investigate the psychophysiological impact of different optical setups on visual acuity at far, intermediate and near distance.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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, between -1 and +1 diopters

Exclusion Criteria:

0,5 diopters of cylinder
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Pharmacology, Medical University of Vienna	Vienna		Austria	1080

Sponsors and Collaborators

Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gerhard Garhofer, assoc. Prof. Dr.med.univ., Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT01873781

Other Study ID Numbers:

OPTH-200912

First Posted:

Jun 10, 2013

Last Update Posted:

Aug 29, 2013

Last Verified:

Aug 1, 2013

Additional relevant MeSH terms:

Hypersensitivity

Study Results

No Results Posted as of Aug 29, 2013