NCT01592643: Nexis-CS0032

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

Completed NA Results posted Last updated 22 December 2021

What this trial tests

NA trial testing Eye Shield in Pain in 30 participants. Completed in 31 October 2013.

Timeline

1 March 2012

Primary endpoint
31 October 2013

31 October 2013

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	30
Start date	1 March 2012
Primary completion	31 October 2013
Estimated completion	31 October 2013
Sites	1 location across United States

Drugs / interventions tested

• Eye Shield

Conditions studied

• Pain — all drugs for Pain →
• Vision Nearsighted — all drugs for Vision Nearsighted →

Sponsor

Stanford University

Who can join

18 and older, any sex, with Pain or Vision Nearsighted. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Eye Shield	0

Mean Change in Uncorrected Visual Acuity Secondary · Six months

LogMAR uncorrected visual acuity. Values closer to zero indicate improved vision

Baseline

Group	Value	95% CI
Eye Shield	1.34	± 0.55

Month six

Group	Value	95% CI
Eye Shield	-0.06	± 0.11

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prospective evaluation of a novel silicone corneal shield after PRK: 6-month efficacy, safety, and predictability outcomes.
   Sáles CS, Manche EE. · · 2019 · PMID 30662255 · DOI 10.2147/opth.s183120