PterygiumFLAPSNCT02866968
Clinical Outcomes of Femtosecond Laser-assisted Pterygium Surgery (FLAPS)
A study testing FLAPS in people with Pterygium, run by Singapore Eye Research Institute at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pterygium
- What is being tested?
- FLAPS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 6 Jul 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pterygium
- Being tested
- FLAPS
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLAPSProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Femtosecond Laser-assisted Pterygium Surgery (FLAPS) | Experimental | All patients included will undergo FLAPS in one eye. Receives: Procedure: FLAPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of FLAPS
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 12 month follow-up
Secondary outcomes (4)
Recurrence free survival over 12 months.
Number of cases with pterygium recurrence during 12 month follow-up
Measured: 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
Measured: Day 0, 7 and 1, 3, 6, 12 months
Refraction
Non-invasive non-contact measurement with autorefractor measured in spherical and cylindrical diopters
Measured: Day 0, 7 and 1, 3, 6, 12 months
Corneal Topography
Non-invasive non-contact scan with OCULUS Pentacam, measurement of cylindrical diopters
Measured: (Day 0, 7 and 1, 3, 6, 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study start6 Jul 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PterygiumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Eye Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jodhbir Mehta, Singapore Eye Research Institute
- Investigators
- Jodhbir S Mehta, Prof, Principal investigator, Singapore Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866968
- Sponsor's protocol ID
- R1361/47/2016
- Acronym
- FLAPS
- Status last verified
- Nov 2017
- First submitted
- 19 Jul 2016
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33673873
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Femtosecond Laser-assisted Pterygium Surgery (FLAPS)
- ClinicalTrials.gov ID
- NCT02866968
- Acronym / sponsor ID
- FLAPS / R1361/47/2016
- Conditions
- Pterygium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Singapore Eye Research InstituteUniversity, hospital or other
- Study start
- 6 Jul 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femtosecond Laser-assisted Pterygium Surgery (FLAPS) | Experimental | Procedure: FLAPSAll patients included will undergo FLAPS in one eye. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLAPSSurgical 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. | Procedure or surgery | Femtosecond Laser-assisted Pterygium Surgery (FLAPS) |
Primary outcome
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
4 secondary outcomes
Recurrence free survival over 12 months.
Time frame: 12 month follow-up
Visual acuity
Time frame: Day 0, 7 and 1, 3, 6, 12 months
Refraction
Time frame: Day 0, 7 and 1, 3, 6, 12 months
Corneal Topography
Time frame: (Day 0, 7 and 1, 3, 6, 12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Derived from this study: PubMed 33673873Ting 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jodhbir S Mehta, Prof principal investigator
Singapore Eye Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLAPS in people with Pterygium, run by Singapore Eye Research Institute at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of FLAPS (time frame: 12 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02866968, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2017.