HyperopiaNCT01135719
A Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser
A study testing LASIK and PRK in people with Hyperopia and Myopia, run by Edward E. Manche at 1 site in United States.
Trial summary
Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized excimer laser. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperopia, Myopia, Astigmatism
- What is being tested?
- LASIK and PRK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to 3 Dec 2022
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects age 21 and older.
- Subjects with nearsightedness, farsightedness and/or astigmatism.
Who cannot join
- Children.
- Women pregnant or nursing.
- Ectatic corneal disease.
- Previous ocular surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser
Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized excimer laser.
Read the detailed description
Subjects with myopia, hyperopia and astigmatism are being randomized by ocular dominance to be treated with either PRK or LASIK. One eye will be treated with a wavefront-guided excimer laser and the fellow eye will be treated with a wavefront optimized excimer laser.
- Conditions
- Hyperopia, Myopia, Astigmatism
- Being tested
- LASIK and PRK
- Keywords
- Myopia, Hyperopia, Astigmatism, PRK, LASIK
- Medical subject headings
- Hyperopia, Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASIK and PRKProcedure or surgery
Also called Allegretto Wave Eye-Q 400 Hz excimer laser, Visx CustomVue excimer laser, Laser in-situ keratomileusis, Photorefractive keratectomy
Wavefront-guided versus wavefront-optimized LASIK or PRK.
| Study group | Role | What they receive |
|---|---|---|
| Wavefront guided LASIK/PRK | Active comparator | Wavefront-guided LASIK/PRK Receives: Procedure: LASIK and PRK |
| Wavefront optimized LASIK/PRK | Active comparator | Wavefornt optimized LASIK/PRK Receives: Procedure: LASIK and PRK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in best spectacle corrected visual acuity.
Measured: One year
Changes in 25 and 5% low contrast visual acuity.
Measured: One year
Improvement in uncorrected visual acuity
Measured: One year
Secondary outcomes (3)
Changes in higher order aberrations.
Measured: One year
Topographic changes.
Measured: One year
Quality of vision changes.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startApr 2009
- Primary completion31 Dec 2013
- Study completion3 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HyperopiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward E. Manche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edward E. Manche, Stanford University
- Investigators
- Edward E. Manche, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135719
- Sponsor's protocol ID
- SU-04302009-2458
- Status last verified
- Dec 2022
- First submitted
- 8 May 2009
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith RG, Manche EE. One-Year Outcomes From a Prospective, Randomized, Eye-to-Eye Comparison of Wavefront-Guided and Wavefront-Optimized PRK in Myopia. J Refract Surg. 2020 Mar 1;36(3):160-168. doi: 10.3928/1081597X-20200129-01.
PubMed 32159820Lee MD, Toy BC, Manche EE. Astigmatic outcomes in myopic wavefront-guided laser in situ keratomileusis versus wavefront-guided photorefractive keratectomy using vector analysis. J Cataract Refract Surg. 2018 Nov;44(11):1350-1354. doi: 10.1016/j.jcrs.2018.07.022. Epub 2018 Sep 7.
PubMed 30201128He L, Manche EE. Contralateral eye-to-eye comparison of wavefront-guided and wavefront-optimized photorefractive keratectomy: a randomized clinical trial. JAMA Ophthalmol. 2015 Jan;133(1):51-9. doi: 10.1001/jamaophthalmol.2014.3876.
PubMed 25321951Kung JS, Manche EE. Quality of Vision After Wavefront-Guided or Wavefront-Optimized LASIK: A Prospective Randomized Contralateral Eye Study. J Refract Surg. 2016 Apr;32(4):230-6. doi: 10.3928/1081597X-20151230-01.
PubMed 27070229He L, Liu A, Manche EE. Wavefront-guided versus wavefront-optimized laser in situ keratomileusis for patients with myopia: a prospective randomized contralateral eye study. Am J Ophthalmol. 2014 Jun;157(6):1170-1178.e1. doi: 10.1016/j.ajo.2014.02.037. Epub 2014 Feb 19.
PubMed 24560995Sales CS, Manche EE. One-year eye-to-eye comparison of wavefront-guided versus wavefront-optimized laser in situ keratomileusis in hyperopes. Clin Ophthalmol. 2014 Nov 12;8:2229-38. doi: 10.2147/OPTH.S70145. eCollection 2014.
PubMed 25419115
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser
- ClinicalTrials.gov ID
- NCT01135719
- Acronym / sponsor ID
- SU-04302009-2458
- Conditions
- Hyperopia, Myopia, Astigmatism
- Keywords
- Myopia, Hyperopia, Astigmatism, PRK, LASIK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Edward E. MancheUniversity, hospital or other
- Study start
- Apr 2009 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 3 Dec 2022 (actual)
- First posted
- 3 Jun 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.
Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized excimer laser.
Detailed description
Subjects with myopia, hyperopia and astigmatism are being randomized by ocular dominance to be treated with either PRK or LASIK. One eye will be treated with a wavefront-guided excimer laser and the fellow eye will be treated with a wavefront optimized excimer laser.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wavefront guided LASIK/PRK | Active comparator | Procedure: LASIK and PRKWavefront-guided LASIK/PRK |
| Wavefront optimized LASIK/PRK | Active comparator | Procedure: LASIK and PRKWavefornt optimized LASIK/PRK |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects age 21 and older.
- Subjects with nearsightedness, farsightedness and/or astigmatism.
Key exclusion criteria (4 listed)
- Children.
- Women pregnant or nursing.
- Ectatic corneal disease.
- Previous ocular surgery.
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 |
|---|---|---|
| LASIK and PRKAlso: Allegretto Wave Eye-Q 400 Hz excimer laser, Visx CustomVue excimer laser, Laser in-situ keratomileusis, Photorefractive keratectomyWavefront-guided versus wavefront-optimized LASIK or PRK. | Procedure or surgery | Wavefront guided LASIK/PRK, Wavefront optimized LASIK/PRK |
Primary outcome
Changes in best spectacle corrected visual acuity.
Time frame: One year
Changes in 25 and 5% low contrast visual acuity.
Time frame: One year
Improvement in uncorrected visual acuity
Time frame: One year
3 secondary outcomes
Changes in higher order aberrations.
Time frame: One year
Topographic changes.
Time frame: One year
Quality of vision changes.
Time frame: One year
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 Dec 2022.
- Background: PubMed 32159820Smith RG, Manche EE. One-Year Outcomes From a Prospective, Randomized, Eye-to-Eye Comparison of Wavefront-Guided and Wavefront-Optimized PRK in Myopia. J Refract Surg. 2020 Mar 1;36(3):160-168. doi: 10.3928/1081597X-20200129-01.
- Background: PubMed 30201128Lee MD, Toy BC, Manche EE. Astigmatic outcomes in myopic wavefront-guided laser in situ keratomileusis versus wavefront-guided photorefractive keratectomy using vector analysis. J Cataract Refract Surg. 2018 Nov;44(11):1350-1354. doi: 10.1016/j.jcrs.2018.07.022. Epub 2018 Sep 7.
- Background: PubMed 25321951He L, Manche EE. Contralateral eye-to-eye comparison of wavefront-guided and wavefront-optimized photorefractive keratectomy: a randomized clinical trial. JAMA Ophthalmol. 2015 Jan;133(1):51-9. doi: 10.1001/jamaophthalmol.2014.3876.
- Background: PubMed 27070229Kung JS, Manche EE. Quality of Vision After Wavefront-Guided or Wavefront-Optimized LASIK: A Prospective Randomized Contralateral Eye Study. J Refract Surg. 2016 Apr;32(4):230-6. doi: 10.3928/1081597X-20151230-01.
- Background: PubMed 24560995He L, Liu A, Manche EE. Wavefront-guided versus wavefront-optimized laser in situ keratomileusis for patients with myopia: a prospective randomized contralateral eye study. Am J Ophthalmol. 2014 Jun;157(6):1170-1178.e1. doi: 10.1016/j.ajo.2014.02.037. Epub 2014 Feb 19.
- Background: PubMed 25419115Sales CS, Manche EE. One-year eye-to-eye comparison of wavefront-guided versus wavefront-optimized laser in situ keratomileusis in hyperopes. Clin Ophthalmol. 2014 Nov 12;8:2229-38. doi: 10.2147/OPTH.S70145. eCollection 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.
Edward E. Manche principal investigator
Stanford 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 LASIK and PRK in people with Hyperopia and Myopia, run by Edward E. Manche 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 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 Dec 2022. 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?
Changes in best spectacle corrected visual acuity. (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01135719, which also lists 6 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 7 Dec 2022.