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Clinical Trials/ISRCTN16821484
ISRCTN16821484
Active, not recruiting
未知

The effect of contact lens parameters and material on fitting characteristics - pilot study

Cooper Vison Inc. (USA)0 sites15 target enrollmentJune 25, 2020

Overview

Phase
未知
Intervention
Not specified
Conditions
Presbyopia multifocal contact lens fitting
Sponsor
Cooper Vison Inc. (USA)
Enrollment
15
Status
Active, not recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 25, 2020
End Date
December 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Cooper Vison Inc. (USA)

Eligibility Criteria

Inclusion Criteria

  • 1\. At least 40 years old
  • 2\. Have read and understood the Participant Information Sheet in English
  • 3\. Have read, signed and dated the Informed Consent
  • 4\. Best corrected visual acuity of at least 20/25 in each eye
  • 5\. Have normal eyes with the exception of the need for visual correction
  • 6\. Current contact lens wearer
  • 7\. Spectacle refraction:
  • Distance: Sphere: \-6\.00D to \+ 4\.00D
  • Astigmatism: 0\.00DC to \-0\.75DC
  • Near Addition: \+0\.75D to \+1\.25D

Exclusion Criteria

  • 1\. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
  • 2\. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti\-depressants, anti\-psychotics, oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops for which contact lens wear could be contraindicated as determined by the investigator
  • 3\. Monocular participants (only one eye with functional vision) or participants fit with only one lens
  • 4\. Any moderate or severe ocular condition observed during the slit\-lamp examination at the enrolment visit
  • 5\. History of herpetic keratitis, ocular surgery or irregular cornea
  • 6\. Known pregnancy or lactation during the study period
  • 7\. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals

Outcomes

Primary Outcomes

Not specified

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