- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02866968
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
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
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Singapore, Singapore, 168751
- Singapore National Eye Centre
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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 |
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EXPERIMENTAL: Femtosecond Laser-assisted Pterygium Surgery (FLAPS)
All patients included will undergo FLAPS in one eye.
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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.
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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
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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12 month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence free survival over 12 months.
Time Frame: 12 month follow-up
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Number of cases with pterygium recurrence during 12 month follow-up
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12 month follow-up
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Visual acuity
Time Frame: Day 0, 7 and 1, 3, 6, 12 months
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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
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Day 0, 7 and 1, 3, 6, 12 months
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Refraction
Time Frame: Day 0, 7 and 1, 3, 6, 12 months
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Non-invasive non-contact measurement with autorefractor measured in spherical and cylindrical diopters
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Day 0, 7 and 1, 3, 6, 12 months
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Corneal Topography
Time Frame: (Day 0, 7 and 1, 3, 6, 12 months)
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Non-invasive non-contact scan with OCULUS Pentacam, measurement of cylindrical diopters
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(Day 0, 7 and 1, 3, 6, 12 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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