Status:
COMPLETED
Evaluation of a Surgical Microscope Mounted Autorefractor When Used on Patients Lying in a Supine Position
Lead Sponsor:
Adventus Technology
Conditions:
Refractive Error
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the accuracy and repeatability of an individually validated prototype autorefractor designed to be mounted on a surgical microscope.
Detailed Description
The purpose of this study is to evaluate the accuracy and repeatability of an individually validated prototype autorefractor designed to be mounted on a surgical microscope. The goal is to evaluate 20...
Eligibility Criteria
Inclusion
- Be at least 18 years of age as of the date of evaluation for the study.
- Have:
- Read the Informed Consent
- been given an explanation of the Informed Consent
- indicated understanding of the Informed Consent
- signed the Informed Consent document.
- Be willing and able to adhere to the instructions set forth in this protocol and able to participate in all scheduled evaluations.
- Be in good general health, based on his/her knowledge.
- Have a refractive error within the range of -10.00 to +30.00 Diopter sphere and up to 5.00 Diopter of refractive cylinder .
- Have manifest refraction (BCVA) Snellen visual acuities (VA) equal to or better than 20/25 in each eye. -
Exclusion
- Subjects may not be enrolled in this study if any of the following apply: The subject is/has:
- Allergy to Tropicamide or a previous adverse reaction to Tropicamide.
- Poor personal hygiene as observed by the investigational site personnel.
- Strabismus
- Currently pregnant (to the best of the subject's knowledge) or is lactating.
- Previous refractive surgery or current or previous orthokeratology treatment.
- Aphakic or pseudophakic or has cataracts that interfere with visual acuity.
- Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia, keratoconus or type II diabetes.
- The need for topical ocular medications or any medication which might interfere with the study evaluations.
- The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
- Slit lamp findings, including but not limited to:
- Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining \> Grade 2 Pterygium Corneal scars within the visual axis Neovascularization or ghost vessels \> 1.0 mm in from the limbus Giant papillary conjunctivitis (GPC) of \> Grade 2 Anterior uveitis or iritis Seborrheic eczema, seborrheic conjunctivitis or blepharitis
- \-
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01827748
Start Date
March 1 2013
End Date
March 1 2013
Last Update
April 12 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ophthalmology Associates
St Louis, Missouri, United States, 63131