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

Pterygium Clinical Trial

— FLAPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866968
• Other study ID #: R1361/47/2016
• Status: Completed
• Phase: N/A
• First received: July 19, 2016
• Last updated: November 19, 2017
• Start date: July 6, 2016
• Est. completion date: June 2017

Study information

• Verified date: November 2017
• Source: Singapore Eye Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pterygium

Intervention

Procedure:
• FLAPS
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.

Locations

Country	Name	City	State
Singapore	Singapore National Eye Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore Eye Research Institute

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of FLAPS	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	12 month follow-up
Secondary	Recurrence free survival over 12 months.	Number of cases with pterygium recurrence during 12 month follow-up	12 month follow-up
Secondary	Visual acuity	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	Day 0, 7 and 1, 3, 6, 12 months
Secondary	Refraction	Non-invasive non-contact measurement with autorefractor measured in spherical and cylindrical diopters	Day 0, 7 and 1, 3, 6, 12 months
Secondary	Corneal Topography	Non-invasive non-contact scan with OCULUS Pentacam, measurement of cylindrical diopters	(Day 0, 7 and 1, 3, 6, 12 months)