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

NCT01827748 | Completed

• 1 other identifier: FA120928
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractive Error

Keywords

Autorefractor

Outcome Measures

Primary Outcomes (1)

• Assessment of the accuracy and repeatability of the Test device compared to the Control

  Comparative auto refractor device measurement variation is defined as +/-0.25 Diopters

  1 Hour

Study Arms (2)

Intraoperative Autorefractor IAR-1

EXPERIMENTAL

This is a auto refractor mounted on an operating microscope.

Device: Intraoperative Autorefractor IAR-1

Hartmann-Shack Auto Refractor

ACTIVE COMPARATOR

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

Device: Hartmann-Shack Auto Refractor

Interventions

Intraoperative Autorefractor IAR-1 DEVICE

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

Intraoperative Autorefractor IAR-1

Hartmann-Shack Auto Refractor DEVICE

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

Hartmann-Shack Auto Refractor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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

Sponsors & Collaborators

• Adventus Technology: lead

Study Sites (1)

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Gregg Berdy, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2013
• First Posted: April 10, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 12, 2013

Record last verified: 2013-04

Locations

US (1)