Incidence and Severity of Dry Eye After Myopic LASIKNCT03228784
The Effect of Ablation Depth on Dry Eye After LASIK Treatment of Myopia
A study testing LASIK in people with Incidence and Severity of Dry Eye After Myopic LASIK, run by Minia University.
Trial summary
The study tried to find the relation between ablation depth and degree of dryness after LASIK treatment of myopic patients Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Incidence and Severity of Dry Eye After Myopic LASIK
- What is being tested?
- LASIK
- Type of treatment
- Surgery or procedure
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2013to 1 May 2014
- 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
- Adult, Older adult
Who may be able to join
- Patients with age ≥ 21 years
- Normal Pentacam maps
- Myopia with spherical equation less than 12 D
- Corneal thickness ≥ 500 Microns
- Calculated residual stromal bed ≥ 280 microns
- No signs or symptoms of dry eye.
Who cannot join
- Keratoconus and forme fruste keratoconus
- Auto-immune diseases
- History of dry eye or previous use of tear substitutes
- Previous ocular surgery
- Pregnant or lactating women.
About this study
The study tried to find the relation between ablation depth and degree of dryness after LASIK treatment of myopic patients
- Being tested
- LASIK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASIKProcedure or surgery
Also called Corneal Flap creation with mechanical microkeratome and stromal ablation with Excimerr laser.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dry eye
Schirmer 1 test in millimeters
Measured: 6 months
Degree of dryness
Tear break up time in seconds
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start1 Jun 2013
- Primary completion1 May 2014
- Study completion1 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incidence and Severity of Dry Eye After Myopic LASIKStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosny Ahmed Zein, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228784
- Sponsor's protocol ID
- 5780
- Status last verified
- Jul 2017
- First submitted
- 14 Jul 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ablation Depth on Dry Eye After LASIK Treatment of Myopia
- ClinicalTrials.gov ID
- NCT03228784
- Acronym / sponsor ID
- 5780
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 1 May 2014 (actual)
- Study completion
- 1 May 2014 (actual)
- First posted
- 25 Jul 2017 (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.
The study tried to find the relation between ablation depth and degree of dryness after LASIK treatment of myopic patients
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with age ≥ 21 years
- Normal Pentacam maps
- Myopia with spherical equation less than 12 D
- Corneal thickness ≥ 500 Microns
- Calculated residual stromal bed ≥ 280 microns
Key exclusion criteria (5 listed)
- Keratoconus and forme fruste keratoconus
- Auto-immune diseases
- History of dry eye or previous use of tear substitutes
- Previous ocular surgery
- Pregnant or lactating women.
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 |
|---|---|---|
| LASIKAlso: Corneal Flap creation with mechanical microkeratome and stromal ablation with Excimerr laser. | Procedure or surgery | – |
Primary outcome
Incidence of dry eye
Time frame: 6 months
Schirmer 1 test in millimeters
Degree of dryness
Time frame: 6 months
Tear break up time in seconds
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 25 Jul 2017.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing LASIK in people with Incidence and Severity of Dry Eye After Myopic LASIK, run by Minia University.
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 6 inclusion and 5 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 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of dry eye (time frame: 6 months). The study lists 2 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 25 Jul 2017.