MyopiaNCT01049724
Lacritin and Heparanase Levels in Human Tears After Laser Refractive Surgery
An observational study of Myopia, run by Fort Belvoir Community Hospital at 1 site in United States.
Trial summary
The purpose of this study is to measure tear lacritin and heparanase levels before and following surgery using a minimal risk procedure to collect tears from patients undergoing PRK or LASIK. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Tear collection
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Nov 2017
- Phase
- Observational
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Active duty military aged 21 to 55 with myopia up to -10.00 diopters eligible for care at Walter Reed Army Medical Center.
Who may be able to join
- Active duty US Army Soldiers eligible for care at FBCH
- Undergoing PRK or LASIK
- Male or female, of any race, and at least 21 years old and not older than 55 years old at the time of the tear collection. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- Appropriately aged individuals who report that their eyes are "normal" and who have no active eye illness as determined by the principal investigator or sub-investigator.
- Ability and willingness to understand and provide informed consent to participate in this study.
- Up to -10.00 diopters of myopia.
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- Subject must expect to be located in the greater Washington DC area for a 12 month period post-operatively.
- Consent of the subject's command (active duty) to participate in the study.
- Access to transportation to meet follow-up requirements.
Who cannot join
- Any reason to be excluded for PRK or LASIK
- Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy. [Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not]
- Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
- Any physical or mental impairment that would preclude participation in any of the examinations.
- Anterior basement membrane dystrophy
- History of recurrent epithelial erosion
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- Significant dry eye (symptomatic with Schirmer <5mm at 5 minutes)
- Other corneal epithelial disorder or healing abnormality
- Individuals with any infectious or inflammatory ocular conditions (e.g. have "pink eye" or uveitis).
- Individuals diagnosed with dry eye or other ocular surface condition, including but not restricted to neurotropic keratitis, anterior basement membrane dystrophy, and recurrent corneal erosions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060
About this study
The purpose of this study is to measure tear lacritin and heparanase levels before and following surgery using a minimal risk procedure to collect tears from patients undergoing PRK or LASIK.
Read the detailed description
Lacritin is a naturally occurring tear protein with antimicrobial activity that is capable of stimulating mitogenesis in human corneal epithelial cells and promoting production of tears in lacrimal gland acinar cells. A recently developed immunoassay for lacritin may help characterize the lacritin response following refractive surgery with the possible development of recombinant lacritin as a novel therapeutic agent for wound healing. Heparanase (HPSE) acts as a regulator for lacritin by cleaving heparan sulfate chains and allowing lacritin to bind. We aim to measure both tear lacritin and HPSE pre- and post-operatively to elucidate lacritin and HPSE's response in patients undergoing PRK (photorefractive keratectomy) and LASIK (Laser-assisted in situ keratomileusis) at the Walter Reed Center for Refractive Surgery.
- Conditions
- Myopia
- Being tested
- Tear collection
- Keywords
- Myopia, refractive surgery, LASIK, PRK, Lacritin, Heparanase
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tear collectionOther
Tear collection
| Study group | Role | What they receive |
|---|---|---|
| PRK | Those patients undergoing photorefractive keratectomy Receives: Other: Tear collection | |
| LASIK | Those undergoing Laser-assisted insitu keratomileusis Receives: Other: Tear collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is tear lacritin levels pre- and post-surgery.
Measured: pre and standard visits up to 6 months post-surgery
Secondary outcomes (1)
The secondary outcome is tear heparanase levels pre- and post-surgery
Measured: pre- and at standard visits up to 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fort Belvoir Community Hospital
- Sponsor type
- US federal agency
- Collaborators
- James Madison University, University of Virginia
- Responsible party
- Principal investigator, COL Bruce Rivers, Fort Belvoir Community Hospital
- Investigators
- Kraig S. Bower, MD, Principal investigator, The Wilmer Eye Institute, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049724
- Sponsor's protocol ID
- 351515
- Status last verified
- Feb 2018
- First submitted
- 13 Jan 2010
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lacritin and Heparanase Levels in Human Tears After Laser Refractive Surgery
- ClinicalTrials.gov ID
- NCT01049724
- Acronym / sponsor ID
- 351515
- Conditions
- Myopia
- Keywords
- Myopia, refractive surgery, LASIK, PRK, Lacritin, Heparanase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Fort Belvoir Community HospitalUS federal agency
- Collaborators
- James Madison University, University of Virginia
- Study start
- Jan 2010
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 14 Jan 2010 (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 purpose of this study is to measure tear lacritin and heparanase levels before and following surgery using a minimal risk procedure to collect tears from patients undergoing PRK or LASIK.
Detailed description
Lacritin is a naturally occurring tear protein with antimicrobial activity that is capable of stimulating mitogenesis in human corneal epithelial cells and promoting production of tears in lacrimal gland acinar cells. A recently developed immunoassay for lacritin may help characterize the lacritin response following refractive surgery with the possible development of recombinant lacritin as a novel therapeutic agent for wound healing. Heparanase (HPSE) acts as a regulator for lacritin by cleaving heparan sulfate chains and allowing lacritin to bind. We aim to measure both tear lacritin and HPSE pre- and post-operatively to elucidate lacritin and HPSE's response in patients undergoing PRK (photorefractive keratectomy) and LASIK (Laser-assisted in situ keratomileusis) at the Walter Reed Center for Refractive Surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRK | – | Other: Tear collectionThose patients undergoing photorefractive keratectomy |
| LASIK | – | Other: Tear collectionThose undergoing Laser-assisted insitu keratomileusis |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Active duty military aged 21 to 55 with myopia up to -10.00 diopters eligible for care at Walter Reed Army Medical Center.
Key inclusion criteria (9 listed)
- Active duty US Army Soldiers eligible for care at FBCH
- Undergoing PRK or LASIK
- Male or female, of any race, and at least 21 years old and not older than 55 years old at the time of the tear collection. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- Appropriately aged individuals who report that their eyes are "normal" and who have no active eye illness as determined by the principal investigator or sub-investigator.
- Ability and willingness to understand and provide informed consent to participate in this study.
Key exclusion criteria (10 listed)
- Any reason to be excluded for PRK or LASIK
- Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy. [Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not]
- Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
- Any physical or mental impairment that would preclude participation in any of the examinations.
- Anterior basement membrane dystrophy
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 |
|---|---|---|
| Tear collectionTear collection | Other | LASIK, PRK |
Primary outcome
The primary outcome measure is tear lacritin levels pre- and post-surgery.
Time frame: pre and standard visits up to 6 months post-surgery
1 secondary outcome
The secondary outcome is tear heparanase levels pre- and post-surgery
Time frame: pre- and at standard visits up to 6 months post-surgery
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 Feb 2018.
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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.
Kraig S. Bower, MD principal investigator
The Wilmer Eye Institute, Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Fort Belvoir Community Hospital at 1 site in United States.
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 9 inclusion and 10 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 Feb 2018. 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 United States. 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?
The primary outcome measure is tear lacritin levels pre- and post-surgery. (time frame: pre and standard visits up to 6 months post-surgery). 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 Feb 2018.