Pedig IXT1

Active Clinical Trials // Feb 14 2017

sponsored by JAEB

PEDIG ~ Intermittent Exotropia Study 1: A Randomized Trial of Bilateral Lateral Rectus Recession versus Unilateral Lateral Rectus Recession with Medial Rectus Resection for Intermittent Exotropia

Primary Investigator: Yasmin Bradfield, MD

Study Coordinator: Angie Adler

Primary Objective:

To evaluate the effectiveness of bilateral lateral rectus muscle recession versus unilateral lateral rectus recession with medial rectus resection procedures for the treatment of basic type and pseudo divergence excess type intermittent exotropia.

Synopsis of Study Design:

Major Eligibility Criteria

  • Age 3 to < 11 years
  • Intermittent exotropia at distance OR constant exotropia at distance and either intermittent exotropia or exophoria at near
    • Exodeviation at least 10 PD at distance AND near by prism and alternate cover test (PACT)
    • Exodeviation at least 15 PD at distance OR near by PACT
    • Largest exodeviation at either distance, near, or remote distance between 15 and 50 PD (inclusive)
    • Basic type or pseudo divergence excess type
  • Stereoacuity of 400 arcsec or better at near by Preschool Randot stereotest (better of 2 measures)
  • Visual acuity in the worse eye 0.3 logMAR or better (20/40 on ATS HOTV or 70 letters on E-ETDRS)
  • No interocular difference of visual acuity more than 0.2 logMAR (2 lines on ATS HOTV or 10 letters on E-ETDRS testing)
  • No hyperopia greater than +3.50 D spherical equivalent in either eye
  • Absence of high AC/A ratio (exclude > 6:1)
  • No previous intraocular surgery, strabismus surgery, or botulinum toxin treatment
  • Investigator planning to perform surgery for correction of IXT Treatment: Randomization (1:1) to surgical correction of IXT with a bilateral lateral rectus recession (BLRrec) or a unilateral lateral rectus recession with medial rectus resection (R&R)

Visit Schedule:

Enrollment

  • Randomization (the day of surgery or the working day before surgery)
  • Surgery
  • 1 week ± 3 days from surgery
  • 8 weeks ± 2 weeks from surgery
  • 6 months ± 1 month from randomization (masked)
  • 12 months ± 2 months from randomization (masked)
  • 18 months ± 2 months from randomization (masked)
  • 24 months ± 2 months from randomization (masked)
  • 30 months ± 2 months from randomization (masked)
  • 3-Year Primary Outcome Exam: 3 years ± 2 months from randomization (masked)

For more information contact Angie Adler at 608-265-7557