Corneal Epithelial Permeability
Conditions
Keywords
continuous contact lens wear, silicone hydrogel contact lenses, irrigation, corneal epithelial permeability, contact lens-related adverse events
Brief summary
This study sought to determine whether daily irrigation with sterile saline solution during silicone hydrogel (SiH) contact lens continuous wear (CW) could improve ocular surface integrity and reduce the risk of adverse events.
Detailed description
The purpose of this study was to determine whether daily irrigation with sterile saline solution during silicone hydrogel (SiH) contact lens 30-day continuous wear (CW) can mitigate increases in corneal epithelial permeability (Pdc) and reduce the risk of mechanical, contact lens-induced, inflammatory, and overall adverse events. 161 non-contact lens wearers were fit with SiH contact lenses and randomized to either a treatment (n = 81) or control (n = 80) group for 30-day CW. Subjects in the treatment group irrigated every morning and whenever dryness symptoms occurred; subjects in the control group did not.
Interventions
DRUGDaily irrigation
Daily morning irrigation of the eye with sterile, borate-buffered, saline solution (Unisol 4) and gentle nudging of the lens to promote solution flow beneath the lens
DEVICE30-day SiH CW
30-day continuous wear of silicone hydrogel contact lenses
Sponsors
University of California, Berkeley
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
Research optometrists conducting eye examinations and technicians conducting fluorometry measurements did not know whether a given subject was in the treatment (irrigating) or control (non-irrigating) group.
Intervention model description
161 non-contact lens wearers were fit with silicone hydrogel (SiH) contact lenses and randomized to either a treatment (n = 81) or control (n = 80) group for 30-day continuous wear (CW). Subjects in the treatment group irrigated every morning and whenever dryness symptoms occurred; subjects in the control group did not.
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* spectacle prescriptions between -1.00 diopter sphere (DS) and -10.00 DS; * less than 0.75 diopters (D) of astigmatism; * free of any ocular disease or systemic disease with ocular manifestation;
Exclusion criteria
* history of contact lens wear within the past year; * history of ocular surgery or serious injury; * presence of corneal scarring; * frequent swimming, smoking, or use of medications w/ ocular side effects;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal epithelial permeability (Pdc) Post-30-Day CW | Post-30-Day CW of SiH contact lenses | Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec after 30 nights of contact lens CW |
| Corneal epithelial permeability (Pdc) at Baseline | Baseline | Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec at baseline with no contact lenses |
| Corneal epithelial permeability (Pdc) Post-1-Day CW | Post-1-Day CW of SiH contact lenses | Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec after 1 night of contact lens CW |
| Risk of adverse events | Post-30-day CW of SiH contact lenses | Odds ratios (OR) for adverse events: contact lens-induced, mechanically-induced, inflammatory, and overall |
Outcome results
None listed