Dr. Rodney Gutner is doing a research study on a small investigational ocular insert device. The device is made of plastic materials similar to those used in contact lenses, and it is placed under the upper eyelid. There will be up to four visits at NECO. The fist visit involves a screening, including aspects of an eye exam and completing a questionnaire. This will take about 1 hour. Subjects who proceed beyond this will then have an ocular insert device placed under the upper lid of one eye. After an initial evaluation, they will wear it for about 1.5 to 2 hours while doing their normal routine. After this, there will be another examination lasting about 30 minutes to determine whether the subject should continue. Those who do will learn how to insert and remove the ocular insert device and be scheduled for a second appointment and examination of about an hour long 7 ± 2 days later. The device will be worn continuously 24 hours a day. Subsequent one hour visits will be about one and three weeks after the second visit. So the study’s duration is about four weeks for each subject. Among inclusion criteria for subjects are: 1. Be at least 18 years of age 2. Have a best visual acuity of at least 20/30 in each eye 3. Have no ocular disease 4. Be willing to not wear contact lenses for at least 12 hours before the first appointment and between the first and fourth appointments 5. Have not had LASIK or other corneal refractive surgery Reimbursement for each subject’s time and participation for the first visit will be up to $125 depending on how far a subject progresses. Reimbursement for subsequent visits will be $125 per visit. Appointments will be scheduled during the morning and early afternoon. The current availability of appointments are: 1. Monday July 8th for the first visit to be followed up on Mondays July 15th, 22, and August 5th. 2. Wednesday July 10th for the first visit to be followed up on Thursdays July 18th, 25th, and August 8th. 3. Thursday July 11th for the first visit to be followed up on Thursday July 18th, 25th, and August 8th. For further information or to schedule an appointment convenient for you, contact: Whittney Varney (study coordinator) 207-944-3985 [email protected]
Posted on: Mon, 15 Jul 2013 13:47:45 +0000
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