Hyperopic PresbyopiaPhase 4NCT01628146
Prospective Investigation of SUPRACOR Visual Outcomes of Presbyopic Hyperopic Patients With and Without Astigmatism
A Phase 4 study testing SUPRACOR LASIK treatment in people with Hyperopic Presbyopia, run by Technolas Perfect Vision GmbH at 1 site in Ireland.
Trial summary
This phase IV study is an open, prospective, single-center, single-surgeon bilateral eye study to investigate the bilateral uncorrected intermediate visual acuity of presbyopic hyperopic patients, who have been treated with Presbyopia Algorithm SUPRACOR. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperopic Presbyopia
- What is being tested?
- SUPRACOR LASIK treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- Sep 2012to Oct 2015
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be at least 48 years old and not older than 65 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.
- Manifest Refraction for both eyes:
- Sphere: +0.75 D to +5.00 D
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- Cylinder: -2.0 D to 0.0 D
- Spherical Equivalent: +0.75 D to +4.0 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
- The proper SUPRACOR treatment for the patient must target the dominant eyes for distance at 0.0/ 0.25 dpt and the following eye for near at -0.5/-0.75. The delta between the targets must remain 0.5 dpt
- Subjects who have be screened successfully for acceptance of the SUPRACOR 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 0.50 D 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 decimal distance visual acuity (VA) measured with the phoropter must be correctable to at least 1.0 (Snellen20/20 or 6/6) in both eyes.
- Mesopic pupil size measured with Zywave II WaveFront Aberrometer and the special Pupil-o-Meter function must be between 3.5mm and 6.5 mm
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.
- Subject for whom a flap thickness other than 100-120µm is planed
- 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.
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- Subjects with evidence of retinal vascular disease.
- 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 study during this study.
- Subjects with an ocular muscle disorder including a strabismus or nystagmus, or other disorders affecting fixation.
- Subjects at risk for angle closure.
- Subjects who have Diabetics
- Subjects who have Cataract
- Subject who have Dry Eye syndrome as evaluated with the "Tear Break Up-Time (TBUT)" Within this study protocol a TBUT ≥7 seconds is acceptable.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: PHASE IV STUDY # 1162. Prospective Investigation of SUPRACOR Visual Outcomes of Presbyopic Hyperopic Patients With and Without Astigmatism
This phase IV study is an open, prospective, single-center, single-surgeon bilateral eye study to investigate the bilateral uncorrected intermediate visual acuity of presbyopic hyperopic patients, who have been treated with Presbyopia Algorithm SUPRACOR.
Read the detailed description
The developed software algorithm SUPRACOR 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 hyperopic cases. In addition to the treatment for the distance vision an additional central ablation component will be added to address the near vision.
Excimer Laser Technolas® 217z100P, High Speed Session Management Software (KERACOR V5.0) and ZYOPTIX Cards as well as all the diagnostic devices that are used in the #1162 study are CE certified and are used for their standard purpose.
This study will be conducted at Mater Private Hospital (Eye Laser Department) by Professor Michael O'Keefe who would recruit up to 40 subjects according to the inclusion/exclusion criteria.
- Conditions
- Hyperopic Presbyopia
- Being tested
- SUPRACOR LASIK treatment
- Keywords
- Presbyopia, hyperopia, Supracor, contrast sensitivity
- Medical subject headings
- Presbyopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUPRACOR LASIK treatmentDevice
Also called LASIK
The SUPRACOR algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction.
| Study group | Role | What they receive |
|---|---|---|
| SUPRACOR LASIK treatment | Experimental | SUPRACOR LASIK treatment Receives: Device: SUPRACOR LASIK treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
High contrast intermediate visual acuity
The percentage of treated patients with a binocular uncorrected high contrast intermediate VA of 20/32 (0.4) or better. This percentage should be equal or greater than 60%.
Measured: The study endpoints will be calculated for the 6-Month follow-up examination.
Secondary outcomes (2)
Contrast sensitivity
For all treated patients the mean value of the binocular photopic contrast sensitivity (log) for the various spatial frequencies should not decrease more than 0.30.
Measured: The study endpoints will be calculated for the 3-Month and 6-Month follow-up examination. The defined study endpoints should be fulfilled at least for the final examination at 6-Month.
Patient satisfaction
The percentage of satisfied patient post SUPRACOR treatment. This percentage should be equal or greater than 75%.
Measured: The study endpoints will be calculated for the 3-Month and 6-Month follow-up examination. The defined study endpoints should be fulfilled at least for the final examination at 6-Month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperopic PresbyopiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technolas Perfect Vision GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael O'Keefe, MB, BAO, BcH, Principal investigator, Mater Private Hospital, Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628146
- Sponsor's protocol ID
- 1162
- Status last verified
- May 2015
- First submitted
- 6 Jun 2012
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
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
- PHASE IV STUDY # 1162. Prospective Investigation of SUPRACOR Visual Outcomes of Presbyopic Hyperopic Patients With and Without Astigmatism
- ClinicalTrials.gov ID
- NCT01628146
- Acronym / sponsor ID
- 1162
- Conditions
- Hyperopic Presbyopia
- Keywords
- Presbyopia, hyperopia, Supracor, contrast sensitivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Technolas Perfect Vision GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 26 Jun 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 phase IV study is an open, prospective, single-center, single-surgeon bilateral eye study to investigate the bilateral uncorrected intermediate visual acuity of presbyopic hyperopic patients, who have been treated with Presbyopia Algorithm SUPRACOR.
Detailed description
The developed software algorithm SUPRACOR 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 hyperopic cases. In addition to the treatment for the distance vision an additional central ablation component will be added to address the near vision.
Excimer Laser Technolas® 217z100P, High Speed Session Management Software (KERACOR V5.0) and ZYOPTIX Cards as well as all the diagnostic devices that are used in the #1162 study are CE certified and are used for their standard purpose.
This study will be conducted at Mater Private Hospital (Eye Laser Department) by Professor Michael O'Keefe who would recruit up to 40 subjects according to the inclusion/exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SUPRACOR LASIK treatment | Experimental | Device: SUPRACOR LASIK treatmentSUPRACOR LASIK treatment |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subjects must be at least 48 years old and not older than 65 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.
- Manifest Refraction for both eyes:
Key exclusion criteria (24 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.
- Subject for whom a flap thickness other than 100-120µm is planed
- 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.
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 |
|---|---|---|
| SUPRACOR LASIK treatmentAlso: LASIKThe SUPRACOR algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction. | Device | SUPRACOR LASIK treatment |
Primary outcome
High contrast intermediate visual acuity
Time frame: The study endpoints will be calculated for the 6-Month follow-up examination.
The percentage of treated patients with a binocular uncorrected high contrast intermediate VA of 20/32 (0.4) or better. This percentage should be equal or greater than 60%.
2 secondary outcomes
Contrast sensitivity
Time frame: The study endpoints will be calculated for the 3-Month and 6-Month follow-up examination. The defined study endpoints should be fulfilled at least for the final examination at 6-Month.
Patient satisfaction
Time frame: The study endpoints will be calculated for the 3-Month and 6-Month follow-up examination. The defined study endpoints should be fulfilled at least for the final examination at 6-Month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
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.
Michael O'Keefe, MB, BAO, BcH principal investigator
Mater Private Hospital, Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SUPRACOR LASIK treatment in people with Hyperopic Presbyopia, run by Technolas Perfect Vision GmbH at 1 site in Ireland.
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 16 inclusion and 24 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: status not confirmed, 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 Ireland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
High contrast intermediate visual acuity (time frame: The study endpoints will be calculated for the 6-Month follow-up examination.). 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 20 May 2015.