Clinical Trial: Clinical Outcomes of Femtosecond Laser-assisted Pterygium Surgery (FLAPS)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Clinical Outcomes of Femtosecond Laser-assisted Pterygium Surgery (FLAPS)

Brief Summary: The study will be a pilot interventional case series aiming to treat 30 patients with Femtosecond Laser-assisted Pterygium Surgery (FLAPS). All patients included will undergo FLAPS in one eye. All procedures will be performed in SNEC by fully qualified surgeons. The doctor is informed of the procedure on the day of.

Detailed Summary:
Sponsor: Singapore Eye Research Institute

Current Primary Outcome: Safety and Tolerability of FLAPS [ Time Frame: 12 month follow-up ]

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Recurrence free survival over 12 months. [ Time Frame: 12 month follow-up ]
    Number of cases with pterygium recurrence during 12 month follow-up
  • Visual acuity [ Time Frame: Day 0, 7 and 1, 3, 6, 12 months ]
    Best-spectacle corrected visual acuity (BSCVA) to be measured with a Snellen chart at 6 meters, then converted to logarithmic minimum angle of resolution unit to allow for averaging and statistical analysis
  • Refraction [ Time Frame: Day 0, 7 and 1, 3, 6, 12 months ]
    Non-invasive non-contact measurement with autorefractor measured in spherical and cylindrical diopters
  • Corneal Topography [ Time Frame: (Day 0, 7 and 1, 3, 6, 12 months) ]
    Non-invasive non-contact scan with OCULUS Pentacam, measurement of cylindrical diopters


Original Secondary Outcome: Same as current

Information By: Singapore Eye Research Institute

Dates:
Date Received: July 19, 2016
Date Started: July 2016
Date Completion: June 2018
Last Updated: August 10, 2016
Last Verified: August 2016