Back to resultsA Pilot Study Investigating the Impact of Different IOL Designs on Subjective 2D and 3D Image Quality
Primary Purpose
Lenses, Intraocular Sensitivity, Visual Acuity
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Cyclopentolatehydrochloride 0,5% eye drops
Sponsored by
About this trial
This is an interventional basic science trial for Lenses focused on measuring IOL
Eligibility Criteria
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
Sites / Locations
- Department of Clinical Pharmacology, Medical University of Vienna
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
30 healthy male and female subjects
Arm Description
30 healthy male and female subjects , age 18-35 years
Outcomes
Primary Outcome Measures
Visual Acuity measured by Early Treatment of Diabetic Retinopathy Study Chart
Secondary Outcome Measures
Contrast Sensitivity measured by Pelli-Robson Contrast Sensitivity Chart
Full Information
NCT ID
NCT02409641
First Posted
February 24, 2015
Last Updated
April 7, 2015
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT02409641
Brief Title
A Pilot Study Investigating the Impact of Different IOL Designs on Subjective 2D and 3D Image Quality
Official Title
A Pilot Study Investigating the Impact of Different IOL Designs on Subjective 2D and 3D Image Quality
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lenses, Intraocular Sensitivity, Visual Acuity
Keywords
IOL
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
30 healthy male and female subjects
Arm Type
Experimental
Arm Description
30 healthy male and female subjects , age 18-35 years
Intervention Type
Drug
Intervention Name(s)
Cyclopentolatehydrochloride 0,5% eye drops
Intervention Description
1 drop in study eye
Primary Outcome Measure Information:
Title
Visual Acuity measured by Early Treatment of Diabetic Retinopathy Study Chart
Time Frame
1 study day
Secondary Outcome Measure Information:
Title
Contrast Sensitivity measured by Pelli-Robson Contrast Sensitivity Chart
Time Frame
1 study day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doreen Schmidl, MD, PhD
Organizational Affiliation
Department of Clinical Pharmacology, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study Investigating the Impact of Different IOL Designs on Subjective 2D and 3D Image Quality
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