Laser in Situ KeratomileusisPROWL-1NCT01526291
Patient-Reported Outcomes With LASIK:PROWL-1
An observational study of Laser in Situ Keratomileusis, run by Food and Drug Administration (FDA) at 1 site in United States.
Trial summary
This study evaluates a questionnaire designed to measure satisfaction and ophthalmic-related quality of life (QOL)in up to 550 active duty subjects prior to and six months following state-of-the-art laser in situ keratomileusis (LASIK). Read more about this study
- Who is it for?
- Ages 21 to 84 years
- Conditions the study is for
- Laser in Situ Keratomileusis
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to not given
- 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Active duty service members residing in San Diego, CA and planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism
Who may be able to join
- Male or female active duty service member, of any race, and at least 21 years old at the time of the pre-operative examination.
- Speak and read English fluently, and have the ability to give informed consent.
- Demonstrated refractive stability, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50 D for myopes or 0.75D for hyperopes during the 12-month period immediately preceding the baseline pre-operative examination.
- Soft contact lens users must have removed their lenses at least 1 week before baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses must have removed their lenses at least 4 weeks prior to baseline measurements, and have 2 central keratometry readings and 2 manifest refractions taken at least 1 week apart that do not differ by more than 0.50D in either meridian; mires shall be regular.
- Express strong motivation and potential ability to return for all follow-up examinations through the 6-month follow-up exam under the care of the treating investigator, and have access to transportation to meet follow-up requirements.
- Reside in the greater San Diego, California metropolitan area.
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- Have been determined to be a good candidate for the LASIK procedure based on the investigator's assessment of medical ophthalmic health, general cognitive function, and physical and social limitations.
- Have a treatment target of bilateral emmetropia or possibly slight hyperopia (+0.25D).
- Have access to a computer with internet service.
- Consent of the subject's command to participate in the study.
Who cannot join
- Previous introcular or corneal surgery of any kind in either eye, including any type of surgery for either refractive or therapeutic purposes.
- Female subjects who are pregnant or breast-feeding, or intend to become pregnant during the 6 month duration of the study.
- Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane), amiodarone hydrochloride (Cordarone) and sumatriptin (Imitrex) or any other tryptan.
- Active ophthalmic disease, neovascularization of the cornea within 1 mm of the intended ablation zone, clinically significant lens opacity, or clinically significant dry eye syndrome unresolved by treatment.
- Evidence of glaucoma or intraocular pressure greater than 22mmHg at baseline.
- Evidence of keratonconus, corneal irregularity, or abnormal videokeratography in either eye.
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- Corneal thickness insufficient to allow the residual remaining stromal bed to be no less than 300 microns in each eye. The residual stromal bed thickness will be determined by subtracting both the LASIK flap thickness and depth of the ablation from the total central corneal thickness measured by pachymetry.
- History of recurrent erosions or epithelial basement dystrophy.
- Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
Trial locations and contacts
1 site in 1 country.
United States1 site
US Naval Medical Center, San Diego
San Diego, California, 92134
About this study
This study evaluates a questionnaire designed to measure satisfaction and ophthalmic-related quality of life (QOL)in up to 550 active duty subjects prior to and six months following state-of-the-art laser in situ keratomileusis (LASIK).
Read the detailed description
The LASIK Quality of Life Collaboration Project (LQOLCP) is a government partnership among the FDA, the Department of Defense, and the National Eye Institute (NEI). This project examines patient-reported outcomes (PROs) following LASIK. This three-phased project is part of FDA's ongoing effort to better monitor and improve the safety and effectiveness of lasers used in LASIK surgery. PROWL-1 is the second phase of the larger LQOLCP project. This prospective, questionnaire-based study will be conducted by the Navy Refractive Surgery Center San Diego in collaboration with the U.S. Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) and the National Eye Institute (NEI). The primary purpose of this study is to explore the psychometric properties of a newly developed questionnaire assessing satisfaction and ophthalmic-related quality of life (QOL) in 550 active duty patients over a period of six months prior to and following state-of-the-art laser in situ keratomileusis (LASIK). Specific topics of interest include: functional limitations, dry eye symptoms, pre-operative expectations, depression, anxiety, post-operative symptoms, dispositional optimism, and satisfaction. Additionally, standard-of-care, non-invasive clinical data will be collected pre- and postoperatively (e.g., best corrected visual acuity, manifest refraction, wavefront aberrometry, corneal topography, and other clinical assessments), and analyzed. The questionnaire in this study is a newly developed instrument which, once psychometrically evaluated in this U.S. Navy/FDA/NEI collaboration, will be used in future large-scale, multicenter FDA clinical studies that include civilian refractive surgery centers throughout the United States.
- Conditions
- Laser in Situ Keratomileusis
- Keywords
- Myopia, Hyperopia, Astigmatism, Patient-reported outcomes, Patient satisfaction, Refractive Error, Emmetropia, Dry eyes, glare, halos, patient expectations
- Medical subject headings
- Myopia, Hyperopia, Astigmatism, Patient Satisfaction, Refractive Errors, Dry Eye Syndromes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Laser in Situ KeratomileusisStudies 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
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Food and Drug Administration (FDA)
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense, United States Naval Medical Center, San Diego, National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Elizabeth M Hofmeister, MD, Principal investigator, US Naval Medical Center, San DiegoMalvina Eydelman, Principal investigator, US FDA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526291
- Sponsor's protocol ID
- NMCSD.2010.0103
- Acronym
- PROWL-1
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2012
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eydelman M, Hilmantel G, Tarver ME, Hofmeister EM, May J, Hammel K, Hays RD, Ferris F 3rd. Symptoms and Satisfaction of Patients in the Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL) Studies. JAMA Ophthalmol. 2017 Jan 1;135(1):13-22. doi: 10.1001/jamaophthalmol.2016.4587.
PubMed 27893066Hays RD, Tarver ME, Spritzer KL, Reise S, Hilmantel G, Hofmeister EM, Hammel K, May J, Ferris F 3rd, Eydelman M. Assessment of the Psychometric Properties of a Questionnaire Assessing Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL). JAMA Ophthalmol. 2017 Jan 1;135(1):3-12. doi: 10.1001/jamaophthalmol.2016.4597.
PubMed 27893063
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcomes With LASIK:PROWL-1
- ClinicalTrials.gov ID
- NCT01526291
- Acronym / sponsor ID
- PROWL-1 / NMCSD.2010.0103
- Conditions
- Laser in Situ Keratomileusis
- Keywords
- Myopia, Hyperopia, Astigmatism, Patient-reported outcomes, Patient satisfaction, Refractive Error, Emmetropia, Dry eyes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Food and Drug Administration (FDA)US federal agency
- Collaborators
- United States Department of Defense, United States Naval Medical Center, San Diego, National Eye Institute (NEI)
- Study start
- Aug 2011
- First posted
- 3 Feb 2012 (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.
This study evaluates a questionnaire designed to measure satisfaction and ophthalmic-related quality of life (QOL)in up to 550 active duty subjects prior to and six months following state-of-the-art laser in situ keratomileusis (LASIK).
Detailed description
The LASIK Quality of Life Collaboration Project (LQOLCP) is a government partnership among the FDA, the Department of Defense, and the National Eye Institute (NEI). This project examines patient-reported outcomes (PROs) following LASIK. This three-phased project is part of FDA's ongoing effort to better monitor and improve the safety and effectiveness of lasers used in LASIK surgery. PROWL-1 is the second phase of the larger LQOLCP project. This prospective, questionnaire-based study will be conducted by the Navy Refractive Surgery Center San Diego in collaboration with the U.S. Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) and the National Eye Institute (NEI). The primary purpose of this study is to explore the psychometric properties of a newly developed questionnaire assessing satisfaction and ophthalmic-related quality of life (QOL) in 550 active duty patients over a period of six months prior to and following state-of-the-art laser in situ keratomileusis (LASIK). Specific topics of interest include: functional limitations, dry eye symptoms, pre-operative expectations, depression, anxiety, post-operative symptoms, dispositional optimism, and satisfaction. Additionally, standard-of-care, non-invasive clinical data will be collected pre- and postoperatively (e.g., best corrected visual acuity, manifest refraction, wavefront aberrometry, corneal topography, and other clinical assessments), and analyzed. The questionnaire in this study is a newly developed instrument which, once psychometrically evaluated in this U.S. Navy/FDA/NEI collaboration, will be used in future large-scale, multicenter FDA clinical studies that include civilian refractive surgery centers throughout the United States.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Active duty service members residing in San Diego, CA and planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism
Key inclusion criteria (10 listed)
- Male or female active duty service member, of any race, and at least 21 years old at the time of the pre-operative examination.
- Speak and read English fluently, and have the ability to give informed consent.
- Demonstrated refractive stability, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50 D for myopes or 0.75D for hyperopes during the 12-month period immediately preceding the baseline pre-operative examination.
- Soft contact lens users must have removed their lenses at least 1 week before baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses must have removed their lenses at least 4 weeks prior to baseline measurements, and have 2 central keratometry readings and 2 manifest refractions taken at least 1 week apart that do not differ by more than 0.50D in either meridian; mires shall be regular.
- Express strong motivation and potential ability to return for all follow-up examinations through the 6-month follow-up exam under the care of the treating investigator, and have access to transportation to meet follow-up requirements.
Key exclusion criteria (9 listed)
- Previous introcular or corneal surgery of any kind in either eye, including any type of surgery for either refractive or therapeutic purposes.
- Female subjects who are pregnant or breast-feeding, or intend to become pregnant during the 6 month duration of the study.
- Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane), amiodarone hydrochloride (Cordarone) and sumatriptin (Imitrex) or any other tryptan.
- Active ophthalmic disease, neovascularization of the cornea within 1 mm of the intended ablation zone, clinically significant lens opacity, or clinically significant dry eye syndrome unresolved by treatment.
- Evidence of glaucoma or intraocular pressure greater than 22mmHg at baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 8 Feb 2018.
- Results publication: PubMed 27893066Eydelman M, Hilmantel G, Tarver ME, Hofmeister EM, May J, Hammel K, Hays RD, Ferris F 3rd. Symptoms and Satisfaction of Patients in the Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL) Studies. JAMA Ophthalmol. 2017 Jan 1;135(1):13-22. doi: 10.1001/jamaophthalmol.2016.4587.
- Results publication: PubMed 27893063Hays RD, Tarver ME, Spritzer KL, Reise S, Hilmantel G, Hofmeister EM, Hammel K, May J, Ferris F 3rd, Eydelman M. Assessment of the Psychometric Properties of a Questionnaire Assessing Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL). JAMA Ophthalmol. 2017 Jan 1;135(1):3-12. doi: 10.1001/jamaophthalmol.2016.4597.
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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.
Elizabeth M Hofmeister, MD principal investigator
US Naval Medical Center, San Diego
Malvina Eydelman principal investigator
US FDA
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 Laser in Situ Keratomileusis, run by Food and Drug Administration (FDA) 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 10 inclusion and 9 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 8 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01526291, which also lists 2 linked publications.
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 8 Feb 2018.