NCT02866968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

July 19, 2016

Last Update Submit

November 19, 2017

Conditions

Pterygium

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability of FLAPS

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

    12 month follow-up

Secondary Outcomes (4)

  • Recurrence free survival over 12 months.

    12 month follow-up

  • Visual acuity

    Day 0, 7 and 1, 3, 6, 12 months

  • Refraction

    Day 0, 7 and 1, 3, 6, 12 months

  • Corneal Topography

    (Day 0, 7 and 1, 3, 6, 12 months)

Study Arms (1)

Femtosecond Laser-assisted Pterygium Surgery (FLAPS)

EXPERIMENTAL

All patients included will undergo FLAPS in one eye.

Procedure: FLAPS

Interventions

FLAPSPROCEDURE

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.

Femtosecond Laser-assisted Pterygium Surgery (FLAPS)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore National Eye Centre

Singapore, 168751, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 33673873DERIVED

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Study Officials

  • Jodhbir S Mehta, Prof

    Singapore Eye Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

July 19, 2016

First Posted

August 15, 2016

Study Start

July 6, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

November 21, 2017

Record last verified: 2017-11

Locations

SG(1)