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

Primary Purpose

Refractive Error

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intraoperative Autorefractor IAR-1

Hartmann-Shack Auto Refractor

About this trial

This is an interventional diagnostic trial for Refractive Error focused on measuring Autorefractor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Be at least 18 years of age as of the date of evaluation for the study.
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.
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

Sites / Locations

Ophthalmology Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intraoperative Autorefractor IAR-1

Hartmann-Shack Auto Refractor

Arm Description

This is a auto refractor mounted on an operating microscope.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01827748

First Posted

March 29, 2013

Last Updated

April 11, 2013

Sponsor

Adventus Technology

1. Study Identification

Unique Protocol Identification Number

NCT01827748

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Adventus Technology

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractive Error

Keywords

Autorefractor

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intraoperative Autorefractor IAR-1

Arm Type

Experimental

Arm Description

This is a auto refractor mounted on an operating microscope.

Arm Title

Hartmann-Shack Auto Refractor

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Intraoperative Autorefractor IAR-1

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Hartmann-Shack Auto Refractor

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

1 Hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gregg Berdy, MD

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ophthalmology Associates

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63131

Country

United States

12. IPD Sharing Statement

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

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