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

November 19, 2017 updated by: Jodhbir Mehta, Singapore Eye Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore, 168751
        • Singapore National Eye Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of FLAPS
Time Frame: 12 month follow-up
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
12 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence free survival over 12 months.
Time Frame: 12 month follow-up
Number of cases with pterygium recurrence during 12 month follow-up
12 month follow-up
Visual acuity
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
Day 0, 7 and 1, 3, 6, 12 months
Refraction
Time Frame: Day 0, 7 and 1, 3, 6, 12 months
Non-invasive non-contact measurement with autorefractor measured in spherical and cylindrical diopters
Day 0, 7 and 1, 3, 6, 12 months
Corneal Topography
Time Frame: (Day 0, 7 and 1, 3, 6, 12 months)
Non-invasive non-contact scan with OCULUS Pentacam, measurement of cylindrical diopters
(Day 0, 7 and 1, 3, 6, 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 6, 2016

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (ESTIMATE)

August 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 19, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R1361/47/2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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