Protocol: ATS01-Ext - Long Term Follow Up of Amblyopia Treatment (Extension Study)
Status: Closed
Start Date: 04/25/1999
End Date: 04/30/2001
Clinical Trial ID: NCT00000170
Public Dataset:  


Long Term Follow Up of Amblyopia Treatment

Protocol
Recruitment of the Occlusion versus Pharmacologic Therapy for Moderate Amblyopia study began in April 1999 and closed in April 2001 after 419 patients were enrolled. Six-month follow-up (primary outcome exam) was completed in November 2001. Two year follow up of patients was completed in July 2003. Extended follow up of study patients with visits at age 10 years was completed in August 2007.  Extended follow up of study patients with visits at age 15 years was completed in August of 2013. For more information click here: Occlusion versus Pharmacologic Therapy for Moderate Amblyopia


Objective of Extended Follow up of Study Patients:

  • Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years.
  • Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care.


Publications:

  1. Pediatric Eye Disease Investigator Group. A randomized trial of atropine vs patching for treatment of moderate amblyopia: follow-up at age 10 years. Arch Ophthalmol 2008;126(8):1039-44
  2. Repka MX, Kraker RT, Beck RW, et al. Monocular oral reading performance after amblyopia treatment in children. Am J Ophthalmol 2008;146(6):942-7
  3. Repka MX, Kraker RT, Beck RW, et al. Contrast sensitivity following amblyopia treatment in children. Arch Ophthalmol 2009;127(9):1225-7 
  4. Kulp MT, Foster NC, Holmes JM, et al. Effect of Ocular Alignment on Emmetropization in Children <10 Years With Amblyopia. Am J Ophthalmol 2012;154(2): 297-302
  5. Pediatric Eye Disease Investigator Group. Atropine vs patching for treatment of moderate amblyopia: follow-up at 15 years of age of a randomized clinical trial. JAMA Opthalmol. Jul 2014;132(7):799-805.
  6. Repka MX, Kraker RT, Holmes JM, for the Pediatric Eye Disease Investigator Group. Atropine vs patching—reply. JAMA Ophthalmology 2015;133:619-20.

 



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