Singapore National Eye Centre
Singapore, 168751
NCT Number: NCT02866968
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.
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Notify Me21 year and older
All sexes
Interventional
Not applicable
Singapore, 168751
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
More specifically, all the following inclusion criteria must be met:
Exclusion criteria
Surgical procedures will involve 1) excision of pterygium tissue from cornea and conjunctiva, 2) resection of residual Tenon and coagulation to stop any bleeding 3) preparation of a 8x8 mm conjunctiva autograft in the superior bulbar conjunctiva with the femtosecond laser (12 o´clock position) and 4) fixation of the graft with fibrin glue to the resection site.
Time frame: 12 month follow-up
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 12 month follow-up
Number of cases with pterygium recurrence during 12 month follow-up
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
Time frame: Day 0, 7 and 1, 3, 6, 12 months
Non-invasive non-contact measurement with autorefractor measured in spherical and cylindrical diopters
Time frame: (Day 0, 7 and 1, 3, 6, 12 months)
Non-invasive non-contact scan with OCULUS Pentacam, measurement of cylindrical diopters
Singapore Eye Research Institute
Other
Acronym: FLAPS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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