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Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain (Nexis-CS0032)

Primary Purpose

Pain, Vision Nearsighted

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eye Shield
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring Corneal shield, PRK, Myopia, Pain, Vision

Eligibility Criteria

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

Inclusion criteria.

  • 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.

Exclusion criteria.

  • Subjects under the age of 18.
  • Patients with excessively thin corneas.
  • Patients with topographic evidence of keratoconus.
  • Patients with ectactic eye disorders.
  • Patients with autoimmune diseases.
  • Patients who are pregnant or nursing.
  • Any other anterior segment abnormality other than that associated with PRK
  • Any abnormalities associated with the eye lids
  • Uncontrolled blepharitis or dry eye
  • Prior laser treatment of the retina
  • Any ophthalmic surgery performed within three (3) months prior to study excluding PRK or LASIK
  • Diagnosis of glaucoma
  • Active diabetic retinopathy
  • Clinically significant inflammation or infection within six (6) months prior to study
  • Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator
  • Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational material
  • Intolerance or hypersensitivity to topical anesthetics, antibiotics, steroids or any other pharmaceuticals that may be used pre and post surgically Specifically known intolerance or hypersensitivity to contact lenses or any component of the investigative material
  • A medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up
  • Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient

Sites / Locations

  • Byers Eye Institute at Stanford

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eye shield

Arm Description

Participants receive eye shield during PRK surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean Change in Uncorrected Visual Acuity
LogMAR uncorrected visual acuity. Values closer to zero indicate improved vision

Full Information

First Posted
April 19, 2012
Last Updated
November 24, 2021
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT01592643
Brief Title
Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain
Acronym
Nexis-CS0032
Official Title
Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2012 (Actual)
Primary Completion Date
October 31, 2013 (Actual)
Study Completion Date
October 31, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this research is to determine if an investigational thin shield over the cornea can safely and effectively reduce or eliminate pain following Post Photorefractive Keratectomy (PRK). 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.
Detailed Description
See above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Vision Nearsighted
Keywords
Corneal shield, PRK, Myopia, Pain, Vision

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eye shield
Arm Type
Experimental
Arm Description
Participants receive eye shield during PRK surgery
Intervention Type
Device
Intervention Name(s)
Eye Shield
Other Intervention Name(s)
Nexis Vision corneal shield
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Pain Score of Four or Greater. Score Range: 0-10, Higher Score Corresponds to More Pain.
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Mean Change in Uncorrected Visual Acuity
Description
LogMAR uncorrected visual acuity. Values closer to zero indicate improved vision
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria. 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. Exclusion criteria. Subjects under the age of 18. Patients with excessively thin corneas. Patients with topographic evidence of keratoconus. Patients with ectactic eye disorders. Patients with autoimmune diseases. Patients who are pregnant or nursing. Any other anterior segment abnormality other than that associated with PRK Any abnormalities associated with the eye lids Uncontrolled blepharitis or dry eye Prior laser treatment of the retina Any ophthalmic surgery performed within three (3) months prior to study excluding PRK or LASIK Diagnosis of glaucoma Active diabetic retinopathy Clinically significant inflammation or infection within six (6) months prior to study Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational material Intolerance or hypersensitivity to topical anesthetics, antibiotics, steroids or any other pharmaceuticals that may be used pre and post surgically Specifically known intolerance or hypersensitivity to contact lenses or any component of the investigative material A medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward E Manche, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Byers Eye Institute at Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30662255
Citation
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.
Results Reference
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Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain

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