MyopiaPhase 3SupracorNCT01322919
Safety and Efficacy Study to Evaluate the Treatment of Both Near and Distance Vision in a Simultaneous Laser Procedure
A Phase 3 study testing Supracor in people with Myopia and Hyperopia, run by Technolas Perfect Vision GmbH at 1 site in Mexico.
Trial summary
By using a new software two consecutive laser treatments have been combined to correct the distance vision and to provide a near vision component in addition to the first treatment. This study will help us to answer 2 questions: 1. How accurately this combined technique corrects distance and near vision 2. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Hyperopia, Presbyopia
- What is being tested?
- Supracor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2010to Mar 2012
- Phase
- Phase 3
- 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 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be at least 45 years old and not older than 85 years
- Subjects must read, understand, and sign an Informed Consent Form (ICF).
- Subjects must be willing and able to return for scheduled follow up examinations through 6 months after surgery.
- Subjects must be willing to have both eyes treated with the laser during the same visit.
- Subjects for study arm-I must have up to +4 diopters (D) of absolute spherical hyperopia (not spherical equivalent), with up to +2.5 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction in both eyes. The spherical equivalent must be no more than +5.25 D. Subjects for study arm-II must have up to -7 diopters (D) of absolute spherical myopia (not spherical equivalent), with up to -4.0 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction in both eyes. The spherical equivalent must be no more than -9.00 D.
- Subjects must have presbyopia as determined by an age-related need for optical aid (> +1.50 D) for reading with their best distance correction.
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- Subjects who have been screened successfully for acceptance of the PresbyLasik simulation
- Subjects who are contact lens wearers must have gas permeable (GP) lenses discontinued for at least 3 weeks and soft lenses discontinued for at least 1 week prior to the preoperative evaluation in the eye to be treated. Contact lens wearers who wear their contact lenses for any amount of time between the preoperative baseline examination and the operative visit must not be treated.
- Corneal topography should be normal.
- Subjects who are contact lens wearers must have 2 central keratometry readings and 2 manifest subjective refractions taken preoperatively at least one week apart. The refraction values must not differ by more than 0.50D as defined by manifest refraction spherical equivalent (MRSE). The keratometry values must not differ from the previous values by more than 0.50D in either meridian.
- High contrast, manifest, best spectacle-corrected logMAR distance visual acuity (VA) must be correctable to at least 0.1 (20/25 or 6/7.5) in both eyes.
Who cannot join
- Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively.
- Eyes for which the baseline manifest subjective refraction exhibits a difference of greater than 0.75D in sphere power, or a difference of greater than 0.50D in cylinder power, or a difference in cylinder axis of more than 15 degrees compared to the baseline cycloplegic subjective refraction. For manifest cylinder of less than 0.75D, the difference in cylinder axis will not be taken into consideration.
- Subjects for whom the preoperative assessment of the ocular topography indicates that one or both eyes are not suitable candidates for treatment based upon the suggested computer-simulated treatment plan.
- Any subject who is going to be co-managed by an ophthalmologist or optometrist who is not approved as a Technolas Perfect Vision GmbH Excimer laser Investigator.
- Subjects with anterior segment pathology, including dry eye syndrome and cataracts which in the Investigator's opinion, would interfere with best spectacle-corrected VA (BSCVA) or a successful treatment.
- Subjects with evidence of retinal vascular disease.
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- Subjects with any residual, recurrent, or active ocular disease, or corneal abnormality that in the Investigator's opinion would interfere with BSCVA or a successful treatment.
- Subjects with signs of keratoconus.
- Subjects with unstable central keratometry readings with irregular mires.
- Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of excimer laser surgery for either refractive or therapeutic purposes.
- Subjects who have a history of Herpes simplex or Herpes zoster keratitis.
- Subjects who have a history of glaucoma or glaucoma suspect.
- Subjects who are immunocompromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, diabetes, autoimmune diseases and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study.
- Subjects taking systemic medications likely to affect wound healing such as corticosteroids or antimetabolites.
- Subjects who are known to be pregnant, lactating, or who plan to become pregnant during the course of the study.
- Subjects with known sensitivity to medications used for standard LASIK.
- Subjects participating in any other ophthalmic clinical trials during this clinical trial.
- Subjects with an ocular muscle disorder including a strabismus or nystagmus, or other disorders affecting fixation.
- Subjects at risk for angle closure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study to Evaluate the Safety and Effectiveness of the Presbyopic LASIK Algorithm
By using a new software two consecutive laser treatments have been combined to correct the distance vision and to provide a near vision component in addition to the first treatment.
This study will help us to answer 2 questions:
- How accurately this combined technique corrects distance and near vision
- Whether the correction is adequate to remove the complete need for supplementary near spectacles
Read the detailed description
LASIK is a surgical technique where the cornea is reshaped using a laser to provide visual correction. Typically, this procedure will only correct your long distance vision requiring the use of supplementary spectacles for reading and near vision.
The Technolas 217z Excimer Laser used to deliver the treatment is approved for use in the European Community for both treatment versions to correct separately the near vision and the distance vision for cases which need one or the other correction.
By using a new software two consecutive treatments have been combined to correct the distance vision and to provide a near vision component in addition to the first treatment.
This study will help us to answer 2 questions:
- How accurately this combined technique corrects distance and near vision
- Whether the correction is adequate to remove the complete need for supplementary near spectacles
- Conditions
- Myopia, Hyperopia, Presbyopia, Refractive Error
- Being tested
- Supracor
- Keywords
- PresbyLASIK, Presbyopia, LASIK, Supracor, refractive, Myopia, Hyperopia
- Medical subject headings
- Myopia, Hyperopia, Presbyopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupracorProcedure or surgery
Also called Myopia, Hyperopia, Presbyopia, PresbyLASIK
All patients will undergo LASIK treatment on their non-dominant eye with a new laser software algorithm designed to treat both the distance and near vision components.
The developed software algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction. This part of the treatment does not show any difference to a regular LASIK treatment for ametropic cases.
In addition to the treatment for the distance vision a central ablation component will be added to address the near vision.
| Study group | Role | What they receive |
|---|---|---|
| Myopic Treatment Arm | Experimental | Patients treated in this arm will have preoperative measurements that indicate a myopic condition of the eye in conjunction with a presbyopic condition Receives: Procedure: Supracor |
| Hyperopic Treatment Arm | Experimental | Patients treated in this arm will have preoperative measurements that indicate a hyperopic condition of the eye in conjunction with a presbyopic condition Receives: Procedure: Supracor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of treated patients with an uncorrected monocular high contrast Near VA of 20/40 or better
Measured: 6 Months
Secondary outcomes (5)
The percentage of treated eyes within +/- 1.00D of target refraction
Measured: 6 Months
The percentage of treated eyes within +/- 0.50D of target refraction
Measured: 6 Months
The percentage of treated eyes with a monocular uncorrected high contrast distance VA of 20/40 or better
Measured: 6 Months
Preservation of VA: Loss of more than 2 lines in monocular BCVA for distance vision
Measured: 6 Months
The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D
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 posted25 Mar 2011 (estimated)
- Study startApr 2010
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technolas Perfect Vision GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enrique Barragan, M.D., Principal investigator, Laser Ocular Hidalgo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322919
- Sponsor's protocol ID
- 1001
- Acronym
- Supracor
- Status last verified
- May 2015
- First submitted
- 23 Mar 2011
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Telandro AP, Steile J 3rd. Presbyopia: perspective on the reality of pseudoaccommodation with LASIK. Ophthalmol Clin North Am. 2006 Mar;19(1):45-69, vi. doi: 10.1016/j.ohc.2005.10.006.
PubMed 16500528Epstein RL, Gurgos MA. Presbyopia treatment by monocular peripheral presbyLASIK. J Refract Surg. 2009 Jun;25(6):516-23. doi: 10.3928/1081597X-20090512-05.
PubMed 19603619Alio JL, Amparo F, Ortiz D, Moreno L. Corneal multifocality with excimer laser for presbyopia correction. Curr Opin Ophthalmol. 2009 Jul;20(4):264-71. doi: 10.1097/icu.0b013e32832a7ded.
PubMed 19537363Pinelli R, Ortiz D, Simonetto A, Bacchi C, Sala E, Alio JL. Correction of presbyopia in hyperopia with a center-distance, paracentral-near technique using the Technolas 217z platform. J Refract Surg. 2008 May;24(5):494-500. doi: 10.3928/1081597X-20080501-07.
PubMed 18494342Illueca C, Alio JL, Mas D, Ortiz D, Perez J, Espinosa J, Esperanza S. Pseudoaccommodation and visual acuity with Technovision presbyLASIK and a theoretical simulated Array multifocal intraocular lens. J Refract Surg. 2008 Apr;24(4):344-9. doi: 10.3928/1081597X-20080401-05.
PubMed 18500082Ortiz D, Alio JL, Illueca C, Mas D, Sala E, Perez J, Espinosa J. Optical analysis of presbyLASIK treatment by a light propagation algorithm. J Refract Surg. 2007 Jan;23(1):39-44. doi: 10.3928/1081-597X-20070101-07.
PubMed 17269242Alio JL, Chaubard JJ, Caliz A, Sala E, Patel S. Correction of presbyopia by technovision central multifocal LASIK (presbyLASIK). J Refract Surg. 2006 May;22(5):453-60. doi: 10.3928/1081-597X-20060501-06.
PubMed 16722483Becker KA, Jaksche A, Holz FG. [PresbyLASIK: treatment approaches with the excimer laser]. Ophthalmologe. 2006 Aug;103(8):667-72. doi: 10.1007/s00347-006-1391-y. German.
PubMed 16850290
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Safety and Effectiveness of the Presbyopic LASIK Algorithm
- ClinicalTrials.gov ID
- NCT01322919
- Acronym / sponsor ID
- Supracor / 1001
- Conditions
- Myopia, Hyperopia, Presbyopia, Refractive Error
- Keywords
- PresbyLASIK, Presbyopia, LASIK, Supracor, refractive, Myopia, Hyperopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Technolas Perfect Vision GmbHIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 25 Mar 2011 (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.
By using a new software two consecutive laser treatments have been combined to correct the distance vision and to provide a near vision component in addition to the first treatment.
This study will help us to answer 2 questions:
- How accurately this combined technique corrects distance and near vision
- Whether the correction is adequate to remove the complete need for supplementary near spectacles
Detailed description
LASIK is a surgical technique where the cornea is reshaped using a laser to provide visual correction. Typically, this procedure will only correct your long distance vision requiring the use of supplementary spectacles for reading and near vision.
The Technolas 217z Excimer Laser used to deliver the treatment is approved for use in the European Community for both treatment versions to correct separately the near vision and the distance vision for cases which need one or the other correction.
By using a new software two consecutive treatments have been combined to correct the distance vision and to provide a near vision component in addition to the first treatment.
This study will help us to answer 2 questions:
- How accurately this combined technique corrects distance and near vision
- Whether the correction is adequate to remove the complete need for supplementary near spectacles
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myopic Treatment Arm | Experimental | Procedure: SupracorPatients treated in this arm will have preoperative measurements that indicate a myopic condition of the eye in conjunction with a presbyopic condition |
| Hyperopic Treatment Arm | Experimental | Procedure: SupracorPatients treated in this arm will have preoperative measurements that indicate a hyperopic condition of the eye in conjunction with a presbyopic condition |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must be at least 45 years old and not older than 85 years
- Subjects must read, understand, and sign an Informed Consent Form (ICF).
- Subjects must be willing and able to return for scheduled follow up examinations through 6 months after surgery.
- Subjects must be willing to have both eyes treated with the laser during the same visit.
- Subjects for study arm-I must have up to +4 diopters (D) of absolute spherical hyperopia (not spherical equivalent), with up to +2.5 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction in both eyes. The spherical equivalent must be no more than +5.25 D. Subjects for study arm-II must have up to -7 diopters (D) of absolute spherical myopia (not spherical equivalent), with up to -4.0 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction in both eyes. The spherical equivalent must be no more than -9.00 D.
Key exclusion criteria (19 listed)
- Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively.
- Eyes for which the baseline manifest subjective refraction exhibits a difference of greater than 0.75D in sphere power, or a difference of greater than 0.50D in cylinder power, or a difference in cylinder axis of more than 15 degrees compared to the baseline cycloplegic subjective refraction. For manifest cylinder of less than 0.75D, the difference in cylinder axis will not be taken into consideration.
- Subjects for whom the preoperative assessment of the ocular topography indicates that one or both eyes are not suitable candidates for treatment based upon the suggested computer-simulated treatment plan.
- Any subject who is going to be co-managed by an ophthalmologist or optometrist who is not approved as a Technolas Perfect Vision GmbH Excimer laser Investigator.
- Subjects with anterior segment pathology, including dry eye syndrome and cataracts which in the Investigator's opinion, would interfere with best spectacle-corrected VA (BSCVA) or a successful treatment.
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 |
|---|---|---|
| SupracorAlso: Myopia, Hyperopia, Presbyopia, PresbyLASIKAll patients will undergo LASIK treatment on their non-dominant eye with a new laser software algorithm designed to treat both the distance and near vision components. The developed software algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction. This part of the treatment does not show any difference to a regular LASIK treatment for ametropic cases. In addition to the treatment for the distance vision a central ablation component will be added to address the near vision. | Procedure or surgery | Hyperopic Treatment Arm, Myopic Treatment Arm |
Primary outcome
The percentage of treated patients with an uncorrected monocular high contrast Near VA of 20/40 or better
Time frame: 6 Months
5 secondary outcomes
The percentage of treated eyes within +/- 1.00D of target refraction
Time frame: 6 Months
The percentage of treated eyes within +/- 0.50D of target refraction
Time frame: 6 Months
The percentage of treated eyes with a monocular uncorrected high contrast distance VA of 20/40 or better
Time frame: 6 Months
Preservation of VA: Loss of more than 2 lines in monocular BCVA for distance vision
Time frame: 6 Months
The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D
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 20 May 2015.
- Background: PubMed 16500528Telandro AP, Steile J 3rd. Presbyopia: perspective on the reality of pseudoaccommodation with LASIK. Ophthalmol Clin North Am. 2006 Mar;19(1):45-69, vi. doi: 10.1016/j.ohc.2005.10.006.
- Results publication: PubMed 19603619Epstein RL, Gurgos MA. Presbyopia treatment by monocular peripheral presbyLASIK. J Refract Surg. 2009 Jun;25(6):516-23. doi: 10.3928/1081597X-20090512-05.
- Results publication: PubMed 19537363Alio JL, Amparo F, Ortiz D, Moreno L. Corneal multifocality with excimer laser for presbyopia correction. Curr Opin Ophthalmol. 2009 Jul;20(4):264-71. doi: 10.1097/icu.0b013e32832a7ded.
- Results publication: PubMed 18494342Pinelli R, Ortiz D, Simonetto A, Bacchi C, Sala E, Alio JL. Correction of presbyopia in hyperopia with a center-distance, paracentral-near technique using the Technolas 217z platform. J Refract Surg. 2008 May;24(5):494-500. doi: 10.3928/1081597X-20080501-07.
- Results publication: PubMed 18500082Illueca C, Alio JL, Mas D, Ortiz D, Perez J, Espinosa J, Esperanza S. Pseudoaccommodation and visual acuity with Technovision presbyLASIK and a theoretical simulated Array multifocal intraocular lens. J Refract Surg. 2008 Apr;24(4):344-9. doi: 10.3928/1081597X-20080401-05.
- Results publication: PubMed 17269242Ortiz D, Alio JL, Illueca C, Mas D, Sala E, Perez J, Espinosa J. Optical analysis of presbyLASIK treatment by a light propagation algorithm. J Refract Surg. 2007 Jan;23(1):39-44. doi: 10.3928/1081-597X-20070101-07.
- Results publication: PubMed 16722483Alio JL, Chaubard JJ, Caliz A, Sala E, Patel S. Correction of presbyopia by technovision central multifocal LASIK (presbyLASIK). J Refract Surg. 2006 May;22(5):453-60. doi: 10.3928/1081-597X-20060501-06.
- Results publication: PubMed 16850290Becker KA, Jaksche A, Holz FG. [PresbyLASIK: treatment approaches with the excimer laser]. Ophthalmologe. 2006 Aug;103(8):667-72. doi: 10.1007/s00347-006-1391-y. German.
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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.
Enrique Barragan, M.D. principal investigator
Laser Ocular Hidalgo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Supracor in people with Myopia and Hyperopia, run by Technolas Perfect Vision GmbH at 1 site in Mexico.
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 11 inclusion and 19 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 20 May 2015. 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 Mexico. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 percentage of treated patients with an uncorrected monocular high contrast Near VA of 20/40 or better (time frame: 6 Months). 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 NCT01322919, which also lists 8 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 20 May 2015.