Laser in Situ KeratomileusisPROWL-2NCT01655420
Patient Reported Outcomes With LASIK: PROWL-2
An observational study of Laser in Situ Keratomileusis, run by Food and Drug Administration (FDA) at 5 sites in United States.
Trial summary
This study evaluates a questionaire designed to measure satisfaction and ophthalmic-related quality of life (QoL) of 300 civilian participants prior to and three 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
- What is being tested?
- LASIK
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2012to 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: Individuals age of 21 to 84 years planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism
Who may be able to join
- Investigators will be instructed to base subject eligibility on the Professional Use Information for their specific laser and keratome system, including but not limited to subjects who:
- Are aged 21 years or older.
- Have the ability to give informed consent.
- Speak and read English fluently.
- Have not previously had any form of refractive surgery, including prior LASIK or cataract surgery.
- May benefit from increased spectacle independence.
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- Have been determined to be a good candidate for the LASIK procedure based on the investigator's assessment of medical and ophthalmic health, general cognitive function, and physical and social limitations.
- Have a treatment target of bilateral emmetropia. Of note, an eye must be treated within 7 days of the fellow eye.
- Express willingness and potential ability to return for all follow-up examinations through the 3-month follow-up exam under the care of the treating investigator.
- Have access to a computer with internet service.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
20/20 Institute
Indianapolis, Indiana, 46240
Durrie Vision
Overland Park, Kansas, 66211
Vance Thompson Vision
Sioux Falls, South Dakota, 57105
Stanford University School of Medicine
Stanford, California, 94304
About this study
Official title: Patient-Reported Outcomes With LASIK: PROWL-2
This study evaluates a questionaire designed to measure satisfaction and ophthalmic-related quality of life (QoL) of 300 civilian participants prior to and three 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's Center for Devices and Radiological Health (CDRH), the Department of Defense, and the National Eye Institute (NEI). This project examines patient-reported outcomes (PROs) following LASIK surgery. 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-2 is the third phase of the larger LQOLCP project. The primary objective of PROWL-2 is to explore the psychometric properties of a computer-based questionnaire assessing the patient-reported outcomes of satisfaction and ophthalmic-related quality of life before and over a period of 3 months following LASIK. This questionnaire initially developed and examined in PROWL-1 (a military population) will be examined psychometrically in a civilian population. PROWL-2 is a prospective, multi-center, observational study in which a participant's pre-operative status will serve as the baseline for one-month and three-month post-surgical comparisons. Three hundred (300) participants planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism will be enrolled in this study from five (5) clinical sites across the United States. Additionally, routine clinical data will be collected pre- and post-operatively (e.g., best corrected visual acuity, manifest refraction, wavefront aberrometry, conreal topography, and other clinical assessments) and questionnaires will be independently administered pre-operatively and at the one-month and three-month post-operative visits.
- Conditions
- Laser in Situ Keratomileusis
- Being tested
- LASIK
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASIKProcedure or surgery
Also called Refractive surgery using LASIK for myopia, hyperopia, or astigmatism
Laser eye surgery
| Study group | Role | What they receive |
|---|---|---|
| LASIK | Individuals aged 21 to 84 years planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism Receives: Procedure: LASIK |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startJul 2012
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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Food and Drug Administration (FDA)
- Sponsor type
- US federal agency
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655420
- Sponsor's protocol ID
- 20112124
- Acronym
- PROWL-2
- Status last verified
- Feb 2018
- First submitted
- 30 Jul 2012
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
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-2
- ClinicalTrials.gov ID
- NCT01655420
- Acronym / sponsor ID
- PROWL-2 / 20112124
- 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
- 300 participants (estimated)
- Lead sponsor
- Food and Drug Administration (FDA)US federal agency
- Collaborators
- National Eye Institute (NEI)
- Study start
- Jul 2012
- First posted
- 1 Aug 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 questionaire designed to measure satisfaction and ophthalmic-related quality of life (QoL) of 300 civilian participants prior to and three 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's Center for Devices and Radiological Health (CDRH), the Department of Defense, and the National Eye Institute (NEI). This project examines patient-reported outcomes (PROs) following LASIK surgery. 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-2 is the third phase of the larger LQOLCP project. The primary objective of PROWL-2 is to explore the psychometric properties of a computer-based questionnaire assessing the patient-reported outcomes of satisfaction and ophthalmic-related quality of life before and over a period of 3 months following LASIK. This questionnaire initially developed and examined in PROWL-1 (a military population) will be examined psychometrically in a civilian population. PROWL-2 is a prospective, multi-center, observational study in which a participant's pre-operative status will serve as the baseline for one-month and three-month post-surgical comparisons. Three hundred (300) participants planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism will be enrolled in this study from five (5) clinical sites across the United States. Additionally, routine clinical data will be collected pre- and post-operatively (e.g., best corrected visual acuity, manifest refraction, wavefront aberrometry, conreal topography, and other clinical assessments) and questionnaires will be independently administered pre-operatively and at the one-month and three-month post-operative visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LASIK | – | Procedure: LASIKIndividuals aged 21 to 84 years planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism |
Who may qualify
- Ages
- 21 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals age of 21 to 84 years planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism
Key inclusion criteria (10 listed)
- Investigators will be instructed to base subject eligibility on the Professional Use Information for their specific laser and keratome system, including but not limited to subjects who:
- Are aged 21 years or older.
- Have the ability to give informed consent.
- Speak and read English fluently.
- Have not previously had any form of refractive surgery, including prior LASIK or cataract surgery.
Key exclusion criteria (0 listed)
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: Refractive surgery using LASIK for myopia, hyperopia, or astigmatismLaser eye surgery | Procedure or surgery | LASIK |
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.
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.
5 sites 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 5 sites 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 0 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 5 sites 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 NCT01655420, 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; AzTrials last refreshed its copy on 1 Nov 2026.