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

Sponsor

Singapore Eye Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02866968

Collaborator

(none)

Enrollment

Location

Arm

10.8

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pterygium	Procedure: FLAPS	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 6, 2016

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Femtosecond Laser-assisted Pterygium Surgery (FLAPS) All patients included will undergo FLAPS in one eye.	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.

Arm

Intervention/Treatment

Experimental: Femtosecond Laser-assisted Pterygium Surgery (FLAPS)

All patients included will undergo FLAPS in one eye.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Singapore National Eye Centre	Singapore		Singapore	168751

Sponsors and Collaborators

Singapore Eye Research Institute

Investigators

Principal Investigator: Jodhbir S Mehta, Prof, Singapore Eye Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jodhbir Mehta, Prof, Singapore Eye Research Institute

ClinicalTrials.gov Identifier:

NCT02866968

Other Study ID Numbers:

R1361/47/2016

First Posted:

Aug 15, 2016

Last Update Posted:

Nov 21, 2017

Last Verified:

Nov 1, 2017

Additional relevant MeSH terms:

Pterygium

Study Results

No Results Posted as of Nov 21, 2017