Dry EyeNCT02210793
Dry Eye Evaluation After Transepithelial PRK
A study testing transepithelial PRK and LASIK in people with Dry Eye, run by AL-Nour Eye Hospital at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the severity of dry eye syndrome following excimer laser vision correction using no-touch all-laser photorefractive keratectomy in comparison to conventional lasik Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- transepithelial PRK and LASIK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2012to Mar 2013
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Myopia -1 to -6 diopters
- Astigmatism -0.5 to - 4 diopters
Who cannot join
- Pregnancy and lactation
- Keratoconus
- Previous refractive surgery
- Previous herpetic keratitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Dry Eye Following Transepithelial Photorefractive Keratectomy in Comparison to Conventional LASIK: a Comparative Study
The aim of the study is to evaluate the severity of dry eye syndrome following excimer laser vision correction using no-touch all-laser photorefractive keratectomy in comparison to conventional lasik
Read the detailed description
Prospective interventional clinical study 2 groups: Group A : 20 eyes of 10 patients undergoing transepithelial PRK Group B: 20 eyes of 10 patients undergoing LASIK using mechanical microkeratome Tear Break Up Time and Schirmer 2 tests are used to evaluate severity of dry eye before surgery and 1 , 3 and 6 months postoperative Follow up period : 6 months
- Conditions
- Dry Eye
- Being tested
- transepithelial PRK, LASIK
- Keywords
- Transepithelial PRK, Dry eye, Schirmer test, Tear break up time, Dry eye after advanced surface ablation technique
- 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.
transepithelial PRKProcedure or surgery
LASIKProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Transepithelial PRK | Active comparator | 20 eyes to undergo a no touch , all-laser advanced surface ablation technique termed transepithelial PRK using the Amaris laser platform (Schwind eye-tech solutions Gmbh, Germany) Receives: Procedure: transepithelial PRK |
| Conventional LASIK | Active comparator | 20 eyes to undergo LASIK using a mechanical microkeratome (M2, Moria Surgical, Antony, France) and the Mel 80 excimer laser system(Carl Zeiss Meditec) Receives: Procedure: LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
qualitative assessment of dry eye syndrome
Tear Break Up time is used as a qualitative measure of dry eye after surgery
Measured: 6 months
quantitative of dry eye after surgery
Schirmer test is used as a quantitative measure of dry eye after surgery
Measured: 6 months
Secondary outcomes (1)
haze
haze is a known possible complication of surface ablation Its severity can be graded according to a slit lamp scoring system
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 posted7 Aug 2014 (estimated)
- Study startApr 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AL-Nour Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Sherif, AL-Nour Eye Hospital
- Investigators
- Ahmed M Shalaby, MD, Study director, Cairo UniversityMahmoud H Abu Steit, MD, Study director, Cairo UniversityMohamed Salah, MBBCH, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210793
- Sponsor's protocol ID
- ANH-1
- Other IDs
- ANH-TPRK1
- Status last verified
- Aug 2014
- First submitted
- 2 Aug 2014
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dry Eye Following Transepithelial Photorefractive Keratectomy in Comparison to Conventional LASIK: a Comparative Study
- ClinicalTrials.gov ID
- NCT02210793
- Acronym / sponsor ID
- ANH-1
- Conditions
- Dry Eye
- Keywords
- Transepithelial PRK, Dry eye, Schirmer test, Tear break up time, Dry eye after advanced surface ablation technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AL-Nour Eye HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 7 Aug 2014 (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 aim of the study is to evaluate the severity of dry eye syndrome following excimer laser vision correction using no-touch all-laser photorefractive keratectomy in comparison to conventional lasik
Detailed description
Prospective interventional clinical study 2 groups: Group A : 20 eyes of 10 patients undergoing transepithelial PRK Group B: 20 eyes of 10 patients undergoing LASIK using mechanical microkeratome Tear Break Up Time and Schirmer 2 tests are used to evaluate severity of dry eye before surgery and 1 , 3 and 6 months postoperative Follow up period : 6 months
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transepithelial PRK | Active comparator | Procedure: transepithelial PRK20 eyes to undergo a no touch , all-laser advanced surface ablation technique termed transepithelial PRK using the Amaris laser platform (Schwind eye-tech solutions Gmbh, Germany) |
| Conventional LASIK | Active comparator | Procedure: LASIK20 eyes to undergo LASIK using a mechanical microkeratome (M2, Moria Surgical, Antony, France) and the Mel 80 excimer laser system(Carl Zeiss Meditec) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Myopia -1 to -6 diopters
- Astigmatism -0.5 to - 4 diopters
Key exclusion criteria (4 listed)
- Pregnancy and lactation
- Keratoconus
- Previous refractive surgery
- Previous herpetic keratitis
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 |
|---|---|---|
| transepithelial PRK | Procedure or surgery | Transepithelial PRK |
| LASIK | Procedure or surgery | Conventional LASIK |
Primary outcome
qualitative assessment of dry eye syndrome
Time frame: 6 months
Tear Break Up time is used as a qualitative measure of dry eye after surgery
quantitative of dry eye after surgery
Time frame: 6 months
Schirmer test is used as a quantitative measure of dry eye after surgery
1 secondary outcome
haze
Time frame: 6 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 7 Aug 2014.
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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.
Ahmed M Shalaby, MD study director
Cairo University
Mahmoud H Abu Steit, MD study director
Cairo University
Mohamed Salah, MBBCH study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transepithelial PRK and LASIK in people with Dry Eye, run by AL-Nour Eye Hospital at 1 site in Egypt.
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 2 inclusion and 4 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 7 Aug 2014. 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 Egypt. 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?
qualitative assessment of dry eye syndrome (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 7 Aug 2014.