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Completed

NCT Number: NCT01827748

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

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

-

Treatment and study plan

Intraoperative Autorefractor IAR-1

Device

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

Hartmann-Shack Auto Refractor

Device

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

Primary outcomes

  1. Assessment of the accuracy and repeatability of the Test device compared to the Control

    Time frame: 1 Hour

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

Sponsors and collaborators

Lead sponsor

Adventus Technology

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 10, 2013
Registry last updated
Apr 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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