Risk factors for corneal infiltrates with continuous wear of contact lenses.
OBJECTIVE
To describe the factors associated with symptomatic corneal infiltrates in a postmarket surveillance study of continuous wear contact lenses.


METHODS
Patients intending to wear lotrafilcon A lenses continuously for 30 days and nights were registered in a 1-year study at 131 clinical sites. A self-administered questionnaire was used to gather demographic and other data at baseline. The severity of the incidence of corneal infiltrative events during the year-long study was graded by an independent adjudication committee.


RESULTS
Of 6245 lens wearers, 163 were reported to have symptomatic corneal infiltrative events (2.6%). In 159 wearers, the infiltrates were judged to be lens-related (2.5%). Age < or =25 years and >50 years was significantly associated with the development of corneal infiltrates (< or =25 years OR = 1.75, 95% CI = 1.24-2.48 and >50 years OR = 2.04, 95% CI = 1.40-2.98). Ametropia of > or =5.00 D was significantly associated with corneal infiltrates (OR = 1.60, 95% CI = 1.08-2.37). Study participants who typically wore lenses for >21 consecutive days and nights were significantly less likely to have infiltrates than those who wore lenses for fewer consecutive days and nights (OR = 0.43, 95% CI = 0.24-0.75). Smoking concurrent with contact lens wear was weakly associated with corneal infiltrates (OR = 1.47, CI = 0.99-2.18).


CONCLUSIONS
Patient age, degree of refractive error, and failure to achieve the intended wearing schedule were associated with development of symptomatic corneal infiltrative events.
Chalmers
Robin L
RL
robinchalmers@mindspring.com
McNally
John J
JJ
Schein
Oliver D
OD
Katz
Joanne
J
Tielsch
James M
JM
Alfonso
Eduardo
E
Bullimore
Mark
M
O'Day
Denis
D
Shovlin
Joseph
J
D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D003262:Contact Lenses, Extended-Wear / Q000009:adverse effects*; D003315:Cornea / Q000473:pathology*; D003316:Corneal Diseases / Q000453:epidemiology / Q000209:etiology* / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D020100:Hydrogels / Q000009:adverse effects*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011358:Product Surveillance, Postmarketing; D012030:Refractive Errors / Q000628:therapy*; D012307:Risk Factors; D012720:Severity of Illness Index; D017678:Sex Distribution; D012828:Silicones / Q000009:adverse effects*; D013997:Time Factors; D014481:United States / Q000453:epidemiology; D005466:Fluorocarbons
D020100:Hydrogels; D012828:Silicones; C481129:lotrafilcon A; D005466:Fluorocarbons