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
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)
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- 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