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

Refractive Error Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827748
• Other study ID #: FA120928
• Status: Completed
• Phase: N/A
• First received: March 29, 2013
• Last updated: April 11, 2013
• Start date: March 2013
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Adventus Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Intraoperative Autorefractor IAR-1
This is an auto-refractor mounted on an operating microscope and used with the subject in a supine position
• Hartmann-Shack Auto Refractor
Standard auto-refractor used with subject sitting upright in front of the instrument.

Locations

Country	Name	City	State
United States	Ophthalmology Associates	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Adventus Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes