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

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.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: Intraoperative Autorefractor IAR-1; Device: Hartmann-Shack Auto Refractor

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63131
      • Ophthalmology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intraoperative Autorefractor IAR-1; This is a auto refractor mounted on an operating microscope.	Device: Intraoperative Autorefractor IAR-1; This is an auto-refractor mounted on an operating microscope and used with the subject in a supine position
ACTIVE_COMPARATOR: Hartmann-Shack Auto Refractor; The Hartmann-Shack type auto refractor used with the subject sitting upright in front of the instrument.	Device: Hartmann-Shack Auto Refractor; Standard auto-refractor used with subject sitting upright in front of the instrument.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Adventus Technology
• Investigators: Principal Investigator: Gregg Berdy, MD

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: March 29, 2013
• First Submitted That Met QC Criteria: April 5, 2013
• First Posted (ESTIMATE): April 10, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 12, 2013
• Last Update Submitted That Met QC Criteria: April 11, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Autorefractor
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: FA120928