OM t of c.iii - Vision Research Coordinating Center - Washington ...

2/22/96 Chapter 3 Entry and Enrollment page 3-2
• Either Vogt’s striae in the deep stroma or Fleischer’s ring of at least 2 mm arc or
corneal scarring characteristic of keratoconus in either eye.
• Able to complete at least 3 years of follow-up.
3.4 Exclusion Criteria
If either of the following conditions is present, a patient is not eligible:
• Bilateral corneal transplants
• Non-keratoconic ocular disease in both eyes: cataract, intraocular lens implant,
macular disease, optic nerve disease other than glaucoma (eg, optic neuritis, optic
atrophy)
3.5 Assignment of Patient Identification Numbers
Any candidate appearing for the Baseline Visit is entered into the patient log and
assigned a patient identification number by the Participating Clinic. Once an ID number
is assigned to a patient, it stays with that patient and is not reassigned to another
patient. The patient identification number is constructed in the following manner. The
first and second digits of the patient ID are the Participating Clinic’s identification code.
The third, fourth, fifth, sixth, and seventh digits indicate the sequential number from
the patient log from 00001 to 99999. The eighth and ninth digits are two letters selected
from the patient’s name according to a system chosen by the Participating Clinic (eg,
using first or last initial, or any other method) that is used consistently. The
Coordinating Center is not informed as to how the two letters are selected.
Example:
Clinic ID:
Patient ID# = C1-00023-JS
Digit 1-2 (C1) is Clinic ID.
One alphabetic and one numeric code number assigned by the
Coordinating Center to designate the Clinic
eg, Clinic Identification Code is C1
Patient ID: Digit 3-4-5-6-7 (00023)
Five numbers indicating the sequential order of patients who complete
any part of the Baseline Visit.
These digits are assigned to the CLEK forms distributed by the
Coordinating Center.
Digit 8-9 (JS)
Clinic C1 always uses the patient’s initials.