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

Pain Clinical Trial

— Nexis-CS0032  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592643
• Other study ID #: 22760
• Status: Completed
• Phase: N/A
• Start date: March 1, 2012
• Est. completion date: October 31, 2013

Study information

• Verified date: November 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 31, 2013
• Est. primary completion date: October 31, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myopia
• Pain
• Vision Nearsighted

Intervention

Device:
• Eye Shield
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.

Locations

Country	Name	City	State
United States	Byers Eye Institute at Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sáles 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Pain Score of Four or Greater. Score Range: 0-10, Higher Score Corresponds to More Pain.		Day 30
Secondary	Mean Change in Uncorrected Visual Acuity	LogMAR uncorrected visual acuity. Values closer to zero indicate improved vision	Six months