Clinical Outcomes of Femtosecond Laser-assisted Pterygium Surgery (FLAPS)
- Conditions
- Pterygium
- Interventions
- Procedure: FLAPS
- Registration Number
- NCT02866968
- Lead Sponsor
- Singapore Eye Research Institute
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- A pterygium will be defined as a wing-shaped growth of fibrotic connective tissue onto the cornea originating from the nasal conjunctiva.
- Only patients older than 21 years will be included.
- No gender criteria are applied.
- Only individuals with the mental capacity to provide informed consent will be included.
More specifically, all the following inclusion criteria must be met:
- Patients have primary pterygium encroaching onto the cornea by a minimum of 1 mm.
- Patients are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.
- Patients are willing and able to return for scheduled follow-up examinations for 12 months after the surgery.
- Patients with prior history of pterygium surgery.
- Patients with a prior history of glaucoma filtration surgery.
- Patients with optic atrophy.
- Patients with ocular pathology or disease that might confound the outcome or increase the risk of adverse events.
- Patients with a prior history of vitrectomy.
- Patients with central corneal scarring.
- Patients with residual, recurrent, active or uncontrolled eyelid disease.
- Patients with any conjunctival scarring other than pterygium, that could affect surgery outcome.
- Patients with anterior segment pathology.
- Patients with any corneal abnormality.
- Patients with any progressive retinal disease or subjects with a history or evidence of retinal vascular occlusion and/or hypercoagulability, because of the risks associated with high pressures during suction application.
- Patients with amblyopia or strabismus or those who are at risk for developing strabismus postoperatively as determined by corneal light reflex and cover-uncover testing.
- Patients who are pregnant, lactating, of child-bearing potential and not practising a medically approved method of birth control, or planning to become pregnant during the course of the trial, and patients with other conditions associated with fluctuation of hormones that could lead to refractive changes.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Femtosecond Laser-assisted Pterygium Surgery (FLAPS) FLAPS All patients included will undergo FLAPS in one eye.
- Primary Outcome Measures
Name Time Method Safety and Tolerability of FLAPS 12 month follow-up Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Secondary Outcome Measures
Name Time Method Recurrence free survival over 12 months. 12 month follow-up Number of cases with pterygium recurrence during 12 month follow-up
Visual acuity 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 Day 0, 7 and 1, 3, 6, 12 months Non-invasive non-contact measurement with autorefractor measured in spherical and cylindrical diopters
Corneal Topography (Day 0, 7 and 1, 3, 6, 12 months) Non-invasive non-contact scan with OCULUS Pentacam, measurement of cylindrical diopters
Trial Locations
- Locations (1)
Singapore National Eye Centre
🇸🇬Singapore, Singapore