PresbyopiaPhase 3ISCAFNCT00928122
Intrastromal Correction of Ametropia by a Femtosecond Laser
A Phase 3 study testing Intrastromal Correction of Presbyopia, Intrastromal correction of Myopia and Intrastromal Correction of Hyperopia in people with Presbyopia and Myopia, run by 20/10 Perfect Vision at 3 sites in Germany.
Trial summary
This study evaluates the intrastromal correction of ametropia with a femtosecond laser made by 20/10 PERFECT VISION. This laser generates a beam of ultrashort, infrared pulses which enables very precise cuts in the cornea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presbyopia, Myopia, Hyperopia
- What is being tested?
- Intrastromal Correction of Presbyopia, Intrastromal correction of Myopia and Intrastromal Correction of Hyperopia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesGermany
- Study dates
- Jul 2008to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: > 18 years
- stable distance refraction for at least one year (i.e. a maximum change of 0.5 D)
- in the case of presbyopia: minimum near add +2D to + 4D
- in the case of myopia or hyperopia (without astigmatism): minimal 1D and maximum 3D
- in the case of myopia or hyperopia (with astigmatism): spherical equivalent of minimal 1D and maximum 3D
- BSCVA of the eye to be treated >= 0.63
- patients are willing and in such conditions to come to the follow-up exams
- no further ocular pathologies
Who cannot join
- age: < 18 years
- refraction less than +/- 1 D or higher than +/- 3 D (not valid for presbyopia patients)
- minimal pachymetry of < 500µm
- K-mean < 37 D or > 60 D
- Difference (K-max minus K-min) > 5D
- Difference cycloplegic refraction to subjective refraction more than 1 D (valid only for hyperopia correction)
Show all 25Show fewer
- patients with previous intraocular or corneal surgeries (e.g. post-LASIK or PRK patients). Exemption: standard cataract surgery.
- patients with one or more of the following ocular pathologies:
- keratokonus
- corneal scars
- transplanted cornea
- disorders of wound healing
- trauma
- glaucoma
- epilepsia
- nystagmus
- lack of concentration
- other complicated illnesses
- diabetes mellitus
- instable K-readings as a sign of instable cornea
- weakness of connective tissue
- sensitivity against the drugs used in the study
- continuous wearing of contact lenses before the pre-exam, and before the surgery. At least 14 days before these dates patients must abstain from wearing CL.
- patients in pregnancy or during lactation
- patients who take part in another clinical trial
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Recruiting
Klinik für Refraktive und Ophthalmo-Chirurgie des EJK Niederrhein
Duisburg, 47169
Mark Tomalla, Dr. med., +49 203 508 ext. 1711, Mark.Tomalla@EJK.de
Mark Tomalla, Dr. med.
- Recruiting
FreeVis LASIK Zentrum Mannheim GmbH
Mannheim, 68167
Michael C. Knorz, Prof. Dr., +49 621 383 ext. 3410, mannheim@freevis.de
Michael C. Knorz, Prof. Dr.
- Recruiting
Augenklinik am Marienplatz AG & Co. KG
München, 80331
Tobias Neuhann, Dr. med., +49 89 232410 ext. 0, ceo@a-a-m.de
Tobias Neuhann, Dr. med.
About this study
This study evaluates the intrastromal correction of ametropia with a femtosecond laser made by 20/10 PERFECT VISION. This laser generates a beam of ultrashort, infrared pulses which enables very precise cuts in the cornea. By these cuts lamellae of the cornea are separated locally, and in the consequence the curvature of the cornea is changed, and the correction of the diagnosed ametropia can be achieved. On the contrary to cuts which are generated with a sharp knife, the cuts generated when using a laser can be generated just inside the cornea without opening the surface of the cornea. This means the procedure is minimal-invasive.
The study hypothesis is: Different types of ametropia can be corrected safely and on long-term by intrastromal cuts.
- Conditions
- Presbyopia, Myopia, Hyperopia, Astigmatism
- Being tested
- Intrastromal Correction of Presbyopia, Intrastromal correction of Myopia, Intrastromal Correction of Hyperopia, Intrastromal Correction of Myopia incl. Astigmatism, Intrastromal Correction of Hyperopia incl. Astigmatism
- Medical subject headings
- Presbyopia, Myopia, Hyperopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrastromal Correction of PresbyopiaDevice
Also called - FEMTEC Laser System, - Patient Interface
Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
Intrastromal correction of MyopiaDevice
Also called FEMTEC Laser System
Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
Intrastromal Correction of HyperopiaDevice
Also called FEMTEC Laser System
Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
Intrastromal Correction of Myopia incl. AstigmatismDevice
Also called FEMTEC Laser System
Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
Intrastromal Correction of Hyperopia incl. AstigmatismDevice
Also called FEMTEC Laser System
Applying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability.
| Study group | Role | What they receive |
|---|---|---|
| 1 / Presbyopia | Experimental | Presbyopic patients, slightly hyperopes Receives: Device: Intrastromal Correction of Presbyopia |
| 2 / Myopia | Experimental | Myopic patients without Astigmatism Receives: Device: Intrastromal correction of Myopia |
| 3 / Hyperopia | Experimental | Hyperope patients without Astigmatism Receives: Device: Intrastromal Correction of Hyperopia |
| 4 / Myopia with Astigmatism | Experimental | Myopic patients incl. Astigmatism Receives: Device: Intrastromal Correction of Myopia incl. Astigmatism |
| 5 / Hyperopia with Astigmatism | Experimental | Hyperope patients incl. Astigmatism Receives: Device: Intrastromal Correction of Hyperopia incl. Astigmatism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prove safety and effectiveness as well as improvement in near visual acuity performance and increase in near visual acuity.
Measured: 3 months
Secondary outcomes (2)
Validate the 3 months results
Measured: 6 months
Prove stability of distance visual acuity and safety of the procedure regarding infections and inflammatory response as well as corneal endothelial cell counts.
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 Jun 2009 (estimated)
- Study startJul 2008
- Primary completionJan 2009
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 20/10 Perfect Vision
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gerd U. Auffarth, Prof. Dr., Principal investigator, Universitäts-Augenklinik Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928122
- Sponsor's protocol ID
- ISCAF
- Acronym
- ISCAF
- Status last verified
- Feb 2010
- First submitted
- 3 Jun 2009
- Last updated
- 9 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Khoramnia R, Fitting A, Rabsilber TM, Thomas BC, Auffarth GU, Holzer MP. Intrastromal femtosecond laser surgical compensation of presbyopia with six intrastromal ring cuts: 3-year results. Br J Ophthalmol. 2015 Feb;99(2):170-6. doi: 10.1136/bjophthalmol-2014-305642. Epub 2014 Sep 2.
PubMed 25185255
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrastromal Correction of Ametropia by a Femtosecond Laser
- ClinicalTrials.gov ID
- NCT00928122
- Acronym / sponsor ID
- ISCAF / ISCAF
- Conditions
- Presbyopia, Myopia, Hyperopia, Astigmatism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- 20/10 Perfect VisionIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 25 Jun 2009 (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 the intrastromal correction of ametropia with a femtosecond laser made by 20/10 PERFECT VISION. This laser generates a beam of ultrashort, infrared pulses which enables very precise cuts in the cornea. By these cuts lamellae of the cornea are separated locally, and in the consequence the curvature of the cornea is changed, and the correction of the diagnosed ametropia can be achieved. On the contrary to cuts which are generated with a sharp knife, the cuts generated when using a laser can be generated just inside the cornea without opening the surface of the cornea. This means the procedure is minimal-invasive.
The study hypothesis is: Different types of ametropia can be corrected safely and on long-term by intrastromal cuts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 / Presbyopia | Experimental | Device: Intrastromal Correction of PresbyopiaPresbyopic patients, slightly hyperopes |
| 2 / Myopia | Experimental | Device: Intrastromal correction of MyopiaMyopic patients without Astigmatism |
| 3 / Hyperopia | Experimental | Device: Intrastromal Correction of HyperopiaHyperope patients without Astigmatism |
| 4 / Myopia with Astigmatism | Experimental | Device: Intrastromal Correction of Myopia incl. AstigmatismMyopic patients incl. Astigmatism |
| 5 / Hyperopia with Astigmatism | Experimental | Device: Intrastromal Correction of Hyperopia incl. AstigmatismHyperope patients incl. Astigmatism |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age: > 18 years
- stable distance refraction for at least one year (i.e. a maximum change of 0.5 D)
- in the case of presbyopia: minimum near add +2D to + 4D
- in the case of myopia or hyperopia (without astigmatism): minimal 1D and maximum 3D
- in the case of myopia or hyperopia (with astigmatism): spherical equivalent of minimal 1D and maximum 3D
Key exclusion criteria (25 listed)
- age: < 18 years
- refraction less than +/- 1 D or higher than +/- 3 D (not valid for presbyopia patients)
- minimal pachymetry of < 500µm
- K-mean < 37 D or > 60 D
- Difference (K-max minus K-min) > 5D
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 |
|---|---|---|
| Intrastromal Correction of PresbyopiaAlso: - FEMTEC Laser System, - Patient InterfaceApplying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability. | Device | 1 / Presbyopia |
| Intrastromal correction of MyopiaAlso: FEMTEC Laser SystemApplying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability. | Device | 2 / Myopia |
| Intrastromal Correction of HyperopiaAlso: FEMTEC Laser SystemApplying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability. | Device | 3 / Hyperopia |
| Intrastromal Correction of Myopia incl. AstigmatismAlso: FEMTEC Laser SystemApplying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability. | Device | 4 / Myopia with Astigmatism |
| Intrastromal Correction of Hyperopia incl. AstigmatismAlso: FEMTEC Laser SystemApplying defined, pre-programmed patterns (e.g. rings and/or radial cuts)into the human eye cornea. It is a minimal-invasive procedure which changes the topography of the cornea and by that the refraction ability. | Device | 5 / Hyperopia with Astigmatism |
Primary outcome
Prove safety and effectiveness as well as improvement in near visual acuity performance and increase in near visual acuity.
Time frame: 3 months
2 secondary outcomes
Validate the 3 months results
Time frame: 6 months
Prove stability of distance visual acuity and safety of the procedure regarding infections and inflammatory response as well as corneal endothelial cell counts.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2010.
- Derived from this study: PubMed 25185255Khoramnia R, Fitting A, Rabsilber TM, Thomas BC, Auffarth GU, Holzer MP. Intrastromal femtosecond laser surgical compensation of presbyopia with six intrastromal ring cuts: 3-year results. Br J Ophthalmol. 2015 Feb;99(2):170-6. doi: 10.1136/bjophthalmol-2014-305642. Epub 2014 Sep 2.
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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.
Gerd U. Auffarth, Prof. Dr. principal investigator
Universitäts-Augenklinik Heidelberg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intrastromal Correction of Presbyopia, Intrastromal correction of Myopia and Intrastromal Correction of Hyperopia in people with Presbyopia and Myopia, run by 20/10 Perfect Vision at 3 sites in Germany.
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 8 inclusion and 25 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 9 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mike P. Holzer, PD Dr. med. (+49 6221 56 ext. 6999, mike.holzer@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prove safety and effectiveness as well as improvement in near visual acuity performance and increase in near visual acuity. (time frame: 3 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 NCT00928122, which also lists 1 linked publication.
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 9 Feb 2010; AzTrials last refreshed its copy on 8 Nov 2026.