Clinical Outcomes of Femtosecond Laser-assisted Pterygium Surgery (FLAPS)
NCT ID: NCT02866968
Last Updated: 2017-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2016-07-06
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Femtosecond Laser-assisted Pterygium Surgery (FLAPS)
All patients included will undergo FLAPS in one eye.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
21 Years
ALL
No
Sponsors
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Singapore Eye Research Institute
OTHER
Responsible Party
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Jodhbir Mehta
Prof
Principal Investigators
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Jodhbir S Mehta, Prof
Role: PRINCIPAL_INVESTIGATOR
Singapore Eye Research Institute
Locations
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Singapore National Eye Centre
Singapore, , Singapore
Countries
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References
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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.
Other Identifiers
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R1361/47/2016
Identifier Type: -
Identifier Source: org_study_id