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

Primary Purpose

Pterygium

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
FLAPS
Sponsored by
Singapore Eye Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Singapore National Eye Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Femtosecond Laser-assisted Pterygium Surgery (FLAPS)

Arm Description

All patients included will undergo FLAPS in one eye.

Outcomes

Primary Outcome Measures

Safety and Tolerability of FLAPS
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Recurrence free survival over 12 months.
Number of cases with pterygium recurrence during 12 month follow-up
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
Refraction
Non-invasive non-contact measurement with autorefractor measured in spherical and cylindrical diopters
Corneal Topography
Non-invasive non-contact scan with OCULUS Pentacam, measurement of cylindrical diopters

Full Information

First Posted
July 19, 2016
Last Updated
November 19, 2017
Sponsor
Singapore Eye Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02866968
Brief Title
Clinical Outcomes of Femtosecond Laser-assisted Pterygium Surgery (FLAPS)
Acronym
FLAPS
Official Title
Clinical Outcomes of Femtosecond Laser-assisted Pterygium Surgery (FLAPS)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 6, 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Singapore Eye Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Femtosecond Laser-assisted Pterygium Surgery (FLAPS)
Arm Type
Experimental
Arm Description
All patients included will undergo FLAPS in one eye.
Intervention Type
Procedure
Intervention Name(s)
FLAPS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety and Tolerability of FLAPS
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
12 month follow-up
Secondary Outcome Measure Information:
Title
Recurrence free survival over 12 months.
Description
Number of cases with pterygium recurrence during 12 month follow-up
Time Frame
12 month follow-up
Title
Visual acuity
Description
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
Time Frame
Day 0, 7 and 1, 3, 6, 12 months
Title
Refraction
Description
Non-invasive non-contact measurement with autorefractor measured in spherical and cylindrical diopters
Time Frame
Day 0, 7 and 1, 3, 6, 12 months
Title
Corneal Topography
Description
Non-invasive non-contact scan with OCULUS Pentacam, measurement of cylindrical diopters
Time Frame
(Day 0, 7 and 1, 3, 6, 12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jodhbir S Mehta, Prof
Organizational Affiliation
Singapore Eye Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore National Eye Centre
City
Singapore
ZIP/Postal Code
168751
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
33673873
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.
Results Reference
derived

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

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