Trials Sponsors Conditions Drugs Pricing

Conditions

Pain Vision Nearsighted

Keywords

Corneal shieldPRKMyopiaPainVision

Outcome Measures

Primary Outcomes (1)

Number of Participants With Pain Score of Four or Greater. Score Range: 0-10, Higher Score Corresponds to More Pain.
Day 30

Secondary Outcomes (1)

Mean Change in Uncorrected Visual Acuity
Six months

Study Arms (1)

Eye shield

EXPERIMENTAL

Participants receive eye shield during PRK surgery

Device: Eye Shield

Interventions

Eye ShieldDevice

The thin shield is made of silicone. The materials used to make the corneal shield all have a history of use in medical devices, contact lenses, and/or corneal shields and have been used safely in the eye.

Also known as: Nexis Vision corneal shield

Eye shield

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects age 18 and older with healthy eyes.
Nearsightedness between -0.50 diopters and -11.00 diopters with or without astigmatism of up to 3.50 diopters.

You may not qualify if:

Sponsors & Collaborators

Stanford University
Otherlead

Study Sites (1)

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

Related Publications (1)

Sales CS, Manche EE. Prospective evaluation of a novel silicone corneal shield after PRK: 6-month efficacy, safety, and predictability outcomes. Clin Ophthalmol. 2019 Jan 7;13:115-121. doi: 10.2147/OPTH.S183120. eCollection 2019.
PMID: 30662255RESULT

MeSH Terms

Conditions

PainMyopia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRefractive ErrorsEye Diseases

Results Point of Contact

Title: Edward E. Manche
Organization: Stanford University School of Medcine

Study Officials

Edward E Manche, MD
Stanford University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

30 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor of Ophthalmology

Study Record Dates

First Submitted

April 19, 2012

First Posted

May 7, 2012

Study Start

March 1, 2012

Actual (reported)

Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Eye shield

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Eye shield

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Documents

Locations