PresbyopiaPhase 3NCT01025050
Intrastromal Presbyopia Correction by Means of a Femtosecond Laser
A Phase 3 study testing Intrastromal Correction of Presbyopia in people with Presbyopia, run by Technolas Perfect Vision GmbH at 4 sites in Germany.
Trial summary
This clinical study is an open, prospective, multi-centre eye study consisting of three study arms to determine the safety and efficacy of intrastromal incisions for the correction of visual acuity on presbyopic eyes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presbyopia
- What is being tested?
- Intrastromal Correction of Presbyopia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 4 sitesGermany
- Study dates
- Dec 2009to Dec 2010
- 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: at least 18 years old
- Patients must have read, understood and signed the Patient Information
- Patients are willing and able to return for follow-up examinations
- Stable distance refraction
- Manifested Refraction (see Table 1 for more details) :
- Cylinder: -0.5 D to 0 D
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- Sphere: 0.25 D to 1.25 D
- Spherical equivalent: Minimum 0.25 D
- Best corrected distance visual acuity of the eye to be treated at least 0.8
- Subjects must have presbyopia as determined by an age-related need for optical aid (≥ +1.5 D) for reading with their best distance correction.
Who cannot join
- Minimum cornea thickness < 500 µm
- Ocular dominance (only non-dominant eyes should be included)
- Uncorrected Near Visual Acuity of 0.5 or better
- Difference between manifested and cycloplegic refraction of > 0.75 D in spherical equivalent
- Median K values < 40 D or > 46 D
- Topographical astigmatism > 5 D
Show all 22Show fewer
- Abnormal corneal topography
- Patients with previous corneal operations on the eye to be treated (e.g. LASIK, PRK, X-Linking; this does not include cataract operations)
- Scarring or opacity of the cornea
- Transplanted cornea
- Connective tissue weaknesses
- Keratectasia and other diseases of the cornea
- Patients with wound-healing disorders such as connective tissue disease, autoimmune illnesses, immunodeficiency illnesses, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis
- Patients regularly taking medicines that could influence the result of the treatment
- Glaucoma or a risk of glaucoma
- Patients with concentration disorders, epilepsy, diabetes mellitus and other complicating diseases
- Patients with disorders of the ocular muscle, such as nystagmus or strabismus
- Sensitivities to the drugs used in this study
- Continual wearing of contact lenses before the pre-examination and before the operation. Patients must refrain from wearing contact lenses for at least 14 days prior to these dates
- Patients who are pregnant or are lactating
- Patients who are participating in another ophthalmological clinical study
- Best corrected distance visual acuity of the second, not to be treated eye is 0.5 or less.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Eye-clinic for Refractive and Ophthalmo-Surgery, EJK Niederrhein
Duisburg, North Rhine-Westphalia, 47169
University Eye Clinic Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
FreeVis LASIK Center Mannheim GmbH
Mannheim, Baden-Wurttemberg, 68167
Augenklinik am Marienplatz AG & Co. KG
Munich, Bavaria, 80331
About this study
This clinical study is an open, prospective, multi-centre eye study consisting of three study arms to determine the safety and efficacy of intrastromal incisions for the correction of visual acuity on presbyopic eyes. The hypothesis of the study is that by means of intrastromal incisions, near visual acuity can be improved in presbyopic eyes in a safe and effective way.
Read the detailed description
This clinical study is an open, prospective, multi-centre eye study consisting of three study arms to determine the safety and efficacy of intrastromal incisions for the correction of visual acuity on presbyopic eyes. The incisions are applied by means of the FEMTEC femtosecond laser system with the INTRACOR software module using patterns consisting of 6 concentric rings and 3 different inner ring diameters. A similar pattern with 5 concentric rings and only one fixed inner diameter is currently under clinical investigation.
The hypothesis of the study is that by means of intrastromal incisions, near visual acuity can be improved in presbyopic eyes in a safe and effective way.
The intrastromal incisions are performed by the femtosecond laser FEMTEC, which is CE certified for various therapeutic indications. The incision eliminates both an epithelial and an endothelial opening of the cornea whereby the minimally invasive character of this form of treatment is guaranteed. A detailed pre-operative examination will ensure that every interested and willing patient fulfils the inclusion criteria of this study. Post-operative examinations, which should document the success of the treatment, are to be carried out after 24 hours, 1 week, 1 month, 3 months and 6 months.
- Conditions
- Presbyopia
- Being tested
- Intrastromal Correction of Presbyopia
- Keywords
- Presbyopia, Intrastromal, Femtosecond Laser, minimal-invasive, INTRACOR, Enhance Near Visual Acuity
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrastromal Correction of PresbyopiaProcedure or surgery
On all patients an intrastromal pattern consisting of concentric rings will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | In this group the smallest ring diameter will be applied. Receives: Procedure: Intrastromal Correction of Presbyopia |
| Group B | Experimental | In this group the intermediate ring diameter will be applied. Receives: Procedure: Intrastromal Correction of Presbyopia |
| Group C | Experimental | In this group the biggest ring diameter will be applied. Receives: Procedure: Intrastromal Correction of Presbyopia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of treated eyes who gained uncorrected near visual acuity of at least 2 lines. This proportion should be greater than 70%.
Measured: 6 months follow up
Secondary outcomes (1)
The proportion of treated eyes that lose more than two lines of best corrected visual acuity (BSCVA). This proportion should be no greater than 5 %.
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2010
- Study completionDec 2010
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technolas Perfect Vision GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025050
- Sponsor's protocol ID
- 0905
- Status last verified
- Jun 2011
- First submitted
- 25 Nov 2009
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thomas BC, Fitting A, Khoramnia R, Rabsilber TM, Auffarth GU, Holzer MP. Long-term outcomes of intrastromal femtosecond laser presbyopia correction: 3-year results. Br J Ophthalmol. 2016 Nov;100(11):1536-1541. doi: 10.1136/bjophthalmol-2015-307672. Epub 2016 Feb 22.
PubMed 26903524
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrastromal Presbyopia Correction by Means of a Femtosecond Laser
- ClinicalTrials.gov ID
- NCT01025050
- Acronym / sponsor ID
- 0905
- Conditions
- Presbyopia
- Keywords
- Presbyopia, Intrastromal, Femtosecond Laser, minimal-invasive, INTRACOR, Enhance Near Visual Acuity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Technolas Perfect Vision GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Dec 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 clinical study is an open, prospective, multi-centre eye study consisting of three study arms to determine the safety and efficacy of intrastromal incisions for the correction of visual acuity on presbyopic eyes. The hypothesis of the study is that by means of intrastromal incisions, near visual acuity can be improved in presbyopic eyes in a safe and effective way.
Detailed description
This clinical study is an open, prospective, multi-centre eye study consisting of three study arms to determine the safety and efficacy of intrastromal incisions for the correction of visual acuity on presbyopic eyes. The incisions are applied by means of the FEMTEC femtosecond laser system with the INTRACOR software module using patterns consisting of 6 concentric rings and 3 different inner ring diameters. A similar pattern with 5 concentric rings and only one fixed inner diameter is currently under clinical investigation.
The hypothesis of the study is that by means of intrastromal incisions, near visual acuity can be improved in presbyopic eyes in a safe and effective way.
The intrastromal incisions are performed by the femtosecond laser FEMTEC, which is CE certified for various therapeutic indications. The incision eliminates both an epithelial and an endothelial opening of the cornea whereby the minimally invasive character of this form of treatment is guaranteed. A detailed pre-operative examination will ensure that every interested and willing patient fulfils the inclusion criteria of this study. Post-operative examinations, which should document the success of the treatment, are to be carried out after 24 hours, 1 week, 1 month, 3 months and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Intrastromal Correction of PresbyopiaIn this group the smallest ring diameter will be applied. |
| Group B | Experimental | Procedure: Intrastromal Correction of PresbyopiaIn this group the intermediate ring diameter will be applied. |
| Group C | Experimental | Procedure: Intrastromal Correction of PresbyopiaIn this group the biggest ring diameter will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: at least 18 years old
- Patients must have read, understood and signed the Patient Information
- Patients are willing and able to return for follow-up examinations
- Stable distance refraction
- Manifested Refraction (see Table 1 for more details) :
Key exclusion criteria (22 listed)
- Minimum cornea thickness < 500 µm
- Ocular dominance (only non-dominant eyes should be included)
- Uncorrected Near Visual Acuity of 0.5 or better
- Difference between manifested and cycloplegic refraction of > 0.75 D in spherical equivalent
- Median K values < 40 D or > 46 D
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 PresbyopiaOn all patients an intrastromal pattern consisting of concentric rings will be applied. | Procedure or surgery | Group A, Group B, Group C |
Primary outcome
The proportion of treated eyes who gained uncorrected near visual acuity of at least 2 lines. This proportion should be greater than 70%.
Time frame: 6 months follow up
1 secondary outcome
The proportion of treated eyes that lose more than two lines of best corrected visual acuity (BSCVA). This proportion should be no greater than 5 %.
Time frame: 6 months follow up
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 9 Jun 2011.
- Derived from this study: PubMed 26903524Thomas BC, Fitting A, Khoramnia R, Rabsilber TM, Auffarth GU, Holzer MP. Long-term outcomes of intrastromal femtosecond laser presbyopia correction: 3-year results. Br J Ophthalmol. 2016 Nov;100(11):1536-1541. doi: 10.1136/bjophthalmol-2015-307672. Epub 2016 Feb 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 in people with Presbyopia, run by Technolas Perfect Vision GmbH at 4 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 10 inclusion and 22 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 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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 proportion of treated eyes who gained uncorrected near visual acuity of at least 2 lines. This proportion should be greater than 70%. (time frame: 6 months follow up). 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 NCT01025050, 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 Jun 2011.