Dry Eye DiseaseNCT04477421
Femtosecond Small Incision Lenticular Extraction in Comparison to Femtosecond Laser Insitu Keratomileusis Regarding Dry Eye Disease
A study testing FS-SMILE and S-LASIK in people with Dry Eye Disease, run by Al-Rasheed University College at 1 site in Iraq.
Trial summary
Comparison of femtosecond small incision lenticule extraction (FS-SMILE) versus Femtosecond laser Insitu Keratomileusis (FS-LASIK) regarding dry eye disease (DED) and corneal sensitivity (CS) after those refractive surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- FS-SMILE and S-LASIK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIraq
- Study dates
- 1 Mar 2017to 31 Oct 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bilateral eyes with spherical correction range from -2 to -6 diopters and cylinder range from 0 to - 3.5 diopters
Who cannot join
- sign or symptom of dry eye disease (tear film breakup time (TBUT) >10 seconds
- Schirmer I test >10 mm /5 minutes)
- corneal or conjunctival staining
- Meibomian gland dysfunction
- Previous ocular and or eyelid medical or surgical treatment
- pregnancy
- Chronic systemic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of femtosecond small incision lenticule extraction (FS-SMILE) versus Femtosecond laser Insitu Keratomileusis (FS-LASIK) regarding dry eye disease (DED) and corneal sensitivity (CS) after those refractive surgeries.
- Conditions
- Dry Eye Disease
- Being tested
- FS-SMILE, S-LASIK
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FS-SMILEProcedure or surgery
Femtosecond small incision lenticule extraction
S-LASIKProcedure or surgery
Femtosecond laser Insitu keratomileusis
| Study group | Role | What they receive |
|---|---|---|
| FS-LASIK Group | Active comparator | 100 eyes of 50 patients underwent bilateral FS-LASIK (Femtosecond laser Insitu Keratomileusis) Receives: Procedure: S-LASIK |
| FS-SMILE | Experimental | 100 eyes of 50 patients who underwent bilateral FS-SMILE (femtosecond small incision lenticule extraction) Receives: Procedure: FS-SMILE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index
Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease
Measured: After 1 month of surgery
Ocular Surface Disease Index
Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease
Measured: After 6 months of surgery
Tear Break-Up Time
Tear Break-Up Time (in seconds)
Measured: After 1 month of surgery
Tear Break-Up Time
Tear Break-Up Time (in seconds)
Measured: After 6 months of surgery
Schirmer I test
Schirmer I test (in mm/5 minutes)
Measured: After 1 month of surgery
Schirmer I test
Schirmer I test (in mm/5 minutes)
Measured: After 6 months of surgery
Oxford score
Oxford score (the score range from 0 to 5), higher value indicate more severe disease
Measured: After 1 month of surgery
Oxford score
Oxford score (the score range from 0 to 5), higher value indicate more severe disease
Measured: After 6 months of surgery
Dry Eye Work Shop scale
Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease
Measured: After 1 month of surgery
Dry Eye Work Shop scale
Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease
Measured: After 6 months of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Mar 2017
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Rasheed University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477421
- Sponsor's protocol ID
- AR200106
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femtosecond Small Incision Lenticular Extraction in Comparison to Femtosecond Laser Insitu Keratomileusis Regarding Dry Eye Disease
- ClinicalTrials.gov ID
- NCT04477421
- Acronym / sponsor ID
- AR200106
- Conditions
- Dry Eye Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Al-Rasheed University CollegeUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 20 Jul 2020 (actual)
- 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.
Comparison of femtosecond small incision lenticule extraction (FS-SMILE) versus Femtosecond laser Insitu Keratomileusis (FS-LASIK) regarding dry eye disease (DED) and corneal sensitivity (CS) after those refractive surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FS-LASIK Group | Active comparator | Procedure: S-LASIK100 eyes of 50 patients underwent bilateral FS-LASIK (Femtosecond laser Insitu Keratomileusis) |
| FS-SMILE | Experimental | Procedure: FS-SMILE100 eyes of 50 patients who underwent bilateral FS-SMILE (femtosecond small incision lenticule extraction) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- bilateral eyes with spherical correction range from -2 to -6 diopters and cylinder range from 0 to - 3.5 diopters
Key exclusion criteria (7 listed)
- sign or symptom of dry eye disease (tear film breakup time (TBUT) >10 seconds
- Schirmer I test >10 mm /5 minutes)
- corneal or conjunctival staining
- Meibomian gland dysfunction
- Previous ocular and or eyelid medical or surgical treatment
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 |
|---|---|---|
| FS-SMILEFemtosecond small incision lenticule extraction | Procedure or surgery | FS-SMILE |
| S-LASIKFemtosecond laser Insitu keratomileusis | Procedure or surgery | FS-LASIK Group |
Primary outcome
Ocular Surface Disease Index
Time frame: After 1 month of surgery
Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease
Ocular Surface Disease Index
Time frame: After 6 months of surgery
Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease
Tear Break-Up Time
Time frame: After 1 month of surgery
Tear Break-Up Time (in seconds)
Tear Break-Up Time
Time frame: After 6 months of surgery
Tear Break-Up Time (in seconds)
Schirmer I test
Time frame: After 1 month of surgery
Schirmer I test (in mm/5 minutes)
Schirmer I test
Time frame: After 6 months of surgery
Schirmer I test (in mm/5 minutes)
Oxford score
Time frame: After 1 month of surgery
Oxford score (the score range from 0 to 5), higher value indicate more severe disease
Oxford score
Time frame: After 6 months of surgery
Oxford score (the score range from 0 to 5), higher value indicate more severe disease
Dry Eye Work Shop scale
Time frame: After 1 month of surgery
Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease
Dry Eye Work Shop scale
Time frame: After 6 months of surgery
Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease
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 20 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FS-SMILE and S-LASIK in people with Dry Eye Disease, run by Al-Rasheed University College at 1 site in Iraq.
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 1 inclusion and 7 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 20 Jul 2020. 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 Iraq. 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?
Ocular Surface Disease Index (time frame: After 1 month of surgery). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2020.