Clinical trial NCT02866968: Clinical Outcomes of Femtosecond Laser-assisted Pterygium Surgery (FLAPS)
Official title: Clinical Outcomes of Femtosecond Laser-assisted Pterygium Surgery (FLAPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pterygium
Lead sponsor: Singapore Eye Research Institute
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Safety and Tolerability of FLAPS
timeFrame: 12 month follow-up
Secondary outcomes:
measure: Recurrence free survival over 12 months.
timeFrame: 12 month follow-up
measure: Visual acuity
timeFrame: Day 0, 7 and 1, 3, 6, 12 months
measure: Refraction
timeFrame: Day 0, 7 and 1, 3, 6, 12 months
measure: Corneal Topography
timeFrame: (Day 0, 7 and 1, 3, 6, 12 months)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore National Eye Centre
Study officials:
affiliation: Singapore Eye Research Institute
name: Jodhbir S Mehta, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ting DSJ, Liu YC, Lee YF, Ji AJS, Tan TE, Htoon HM, Mehta JS. Cosmetic outcome of femtosecond laser-assisted pterygium surgery. Eye Vis (Lond). 2021 Mar 6;8(1):7. doi: 10.1186/s40662-021-00230-w.