Evaluation of a Surgical Microscope Mounted Autorefractor When Used on Patients Lying in a Supine Position

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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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 subjects with both the investigational instrument followed by a commercially available instrument.

Conditions

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Refractive Error

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intraoperative Autorefractor IAR-1

This is a auto refractor mounted on an operating microscope.

Group Type EXPERIMENTAL

Intraoperative Autorefractor IAR-1

Intervention Type DEVICE

This is an auto-refractor mounted on an operating microscope and used with the subject in a supine position

Hartmann-Shack Auto Refractor

The Hartmann-Shack type auto refractor used with the subject sitting upright in front of the instrument.

Group Type ACTIVE_COMPARATOR

Hartmann-Shack Auto Refractor

Intervention Type DEVICE

Standard auto-refractor used with subject sitting upright in front of the instrument.

Interventions

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Intraoperative Autorefractor IAR-1

This is an auto-refractor mounted on an operating microscope and used with the subject in a supine position

Intervention Type DEVICE

Hartmann-Shack Auto Refractor

Standard auto-refractor used with subject sitting upright in front of the instrument.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Be at least 18 years of age as of the date of evaluation for the study.
2. Have:

1. Read the Informed Consent
2. been given an explanation of the Informed Consent
3. indicated understanding of the Informed Consent
4. signed the Informed Consent document.
3. Be willing and able to adhere to the instructions set forth in this protocol and able to participate in all scheduled evaluations.
4. Be in good general health, based on his/her knowledge.
5. Have a refractive error within the range of -10.00 to +30.00 Diopter sphere and up to 5.00 Diopter of refractive cylinder .
6. Have manifest refraction (BCVA) Snellen visual acuities (VA) equal to or better than 20/25 in each eye. -

Exclusion Criteria

Subjects may not be enrolled in this study if any of the following apply: The subject is/has:

1. Allergy to Tropicamide or a previous adverse reaction to Tropicamide.
2. Poor personal hygiene as observed by the investigational site personnel.
3. Strabismus
4. Currently pregnant (to the best of the subject's knowledge) or is lactating.
5. Previous refractive surgery or current or previous orthokeratology treatment.
6. Aphakic or pseudophakic or has cataracts that interfere with visual acuity.
7. 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.
8. The need for topical ocular medications or any medication which might interfere with the study evaluations.
9. 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.
10. 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

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes