Myopic Astigmatism
Conditions
Keywords
CLEAR, Ziemer, FEMTO LDV, Lenticule, Myopic astigmatism
Brief summary
In this multicenter, prospective, interventional, single-arm clinical trial, the aim is to determine safety and efficacy of CLEAR using the FEMTO LDV Z8 in Chinese patients in China. The primary objective is to evaluate the visual outcome after CLEAR using the FEMTO LDV Z8 in myopia and astigmatic myopia at the time point, when stability of manifest refraction spherical equivalent (MRSE) is reached. The corresponding hypothesis is that the percentage of treated eyes with satisfactory Uncorrected Distance Visual Acuity (UCDVA) at the point when stability of MRSE is reached after CLEAR is at least 85% of all treated eyes. This hypothesis has been chosen in line with the recommendations of the Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers issued by the FDA. The secondary objectives are to evaluate the efficacy and safety with respect to stability, predictability, device defects and adverse events of CLEAR using the FEMTO LDV Z8 in myopia and astigmatic myopia during follow-up.
Interventions
DEVICECLEAR
FEMTO LDV Z8 Surgical Laser is intended for use in Corneal Lenticule Extraction for Advanced Refractive correction (CLEAR), also called Curved Lamellar Resection (CLR), for the reduction or elimination of myopia from -0.50 D to -10.00 D, with astigmatism of 0 D to -5.00 D or without astigmatism, and MRSE of -0.50 D to -12.50 D in the eye to be treated in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of ≤ 0.50 D in magnitude.
Sponsors
Tigermed Consulting Co., Ltd
Ziemer Ophthalmic Systems AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Medically suitable for corneal refractive surgery 2. Signed informed consent form 3. Age ≥ 18 years 4. Pre-operative BCVA ≥ 5.0 (corresponding to 20/20 as per Snellen chart lines) 5. Myopia sphere from -0.5 D to -10.00 D 6. Maximum cylinder diopter of -5.00 D 7. Maximum resulting MRSE of -12.5 D 8. Calculated residual stromal thickness ≥ 250 microns 9. Non-contact IOP \< 21mmHg 10. Stable refraction for the past year, as demonstrated by a change in manifest refraction spherical equivalent (MRSE) of ≤ 0.50 D 11. A difference between cycloplegic refraction spherical equivalent and MRSE \< 0.75 D. 12. For contact lens wearers (where applicable) after pre-operative stop of contact lens wear: Stable refraction (within ±0.5 D), as determined by MRSE, on two consecutive examinations at least 1 week apart. 13. Patient willing and able to return to the study site for the follow-up visits, in the judgement of the investigator.
Exclusion criteria
1. Wearing of contact lenses pre-operatively i) soft contact lenses: \<2 weeks before Visit 1 OR from Visit 1 till the day of surgery ii) hard contact lenses: \<1 month before Visit 1 OR from Visit 1 till the day of surgery iii) therapeutic contact lenses (such as Ortho-K): \<3 months before Visit 1 OR from Visit 1 till the day of surgery 2. Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light 3. Residual, recurrent, or active ocular disease or corneal abnormality (including, but not limited to ocular herpes zoster or simplex, active infections and inflammation) 4. History of ocular herpes simplex or herpes zoster keratitis 5. 3 months before the inclusion have taken systemic medication likely to negatively affect wound healing, such as glucocorticosteroide or antimetabolites 6. Severe dry eye 7. Glaucoma 8. Nystagmus or hemofacial spasm preventing placement of the patient interface 9. Previous corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes 10. Unstable central keratometry readings 11. Mesopic pupil diameter \> 8.0 mm 12. Keratometry readings via Sim-K values less than 40.00 D 13. Allergy to medications required in surgery, pre- and post-operative treatment 14. Keratoconus or keratectasia, including patients with suspicion of keratoconus on corneal topography 15. At the time of inclusion, participation in other medical device clinical trials within one month or in drug clinical trials within 3 months 16. Diagnosis of autoimmune disease, connective tissue disease, clinically significant atopic disease, diabetes or AIDS and other acute or chronic illnesses that increases the risk to the subject or confounds the outcomes of this study in the opinion of the study principal investigator 17. Known psychotic disorders associated with delusions (e.g. schizophrenia) 18. Woman who is pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UCDVA (with cycloplegia) | Pre-operative | The primary outcome is the percentage of eyes that achieve satisfactory Uncorrected Distance Visual Acuity (UCDVA) after CLEAR using the FEMTO LDV Z8, at the time point, when stability of MRSE is reached. Satisfactory UCDVA is defined as 20/40, or better, as per Snellen chart lines. |
| UCDVA (without cycloplegia) | Pre-operative | The primary outcome is the percentage of eyes that achieve satisfactory Uncorrected Distance Visual Acuity (UCDVA) after CLEAR using the FEMTO LDV Z8, at the time point, when stability of MRSE is reached. Satisfactory UCDVA is defined as 20/40, or better, as per Snellen chart lines. |
| UCDVA | day 1 | The primary outcome is the percentage of eyes that achieve satisfactory Uncorrected Distance Visual Acuity (UCDVA) after CLEAR using the FEMTO LDV Z8, at the time point, when stability of MRSE is reached. Satisfactory UCDVA is defined as 20/40, or better, as per Snellen chart lines. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stability of MRCYL | Assessed at 3 months, 6 months, 9 months and 12 months post surgery. | The stability of the manifest refractive cylinder (MRCYL) will be evaluated for the whole set of eyes treated for astigmatic myopia. The following statistics for the change in the MRCYL between two consecutive post-operative follow-up visits will be recorded: • percentage of eyes with a change in MRCYL within ±1.0 D and ±0.5 D Stability analyses will be performed on the eyes that had every follow-up exam from 1- month up to the stability time point (the Consistent Cohort), as well as on the eyes that had 2 consecutive post-op exams, but not necessarily every follow-up exam |
| Predictability of MRCYL | Up to 12 months | Percentage of eyes achieving MRCYL within ± 1.00 D of the intended outcome, and within ± 0.50 D of the intended outcome at the point at which stability of MRSE is achieved. |
| Vector analysis (IRC) | Pre-operative | Intended Refractive Correction Vector (IRC) IRC = Preoperative cylinder - Target (attempted) cylinder |
| Vector analysis (SIRC) | Assessed at 3 months, 6 months, 9 months and 12 months post surgery. | Assessment of change in the Surgically Induced Refractive Correction Vector (SIRC) during follow up; assessed until the MRSE stability is reached. SIRC = Preoperative cylinder - Postoperative cylinder |
| Vector analysis (EV) | Assessed at 3 months, 6 months, 9 months and 12 months post surgery. | Assessment of change in the Error Vector during follow up; assessed until the MRSE stability is reached. Error Vector (EV) EV = IRC - SIRC |
| Stability of MRSE | Assessed at 3 months, 6 months, 9 months and 12 months post surgery. | The percentage of eyes with: * a change of less than or equal to 1.00 D of MRSE between two refractions * a change of less than or equal to 0.50 D of MRSE between two refractions will be reported for the corresponding time period. |
| Vector analysis (ER) | Assessed at 3 months, 6 months, 9 months and 12 months post surgery. | Assessment of change in the Error Ratio during follow up; assessed until the MRSE stability is reached. Error Ratio (ER) ER = magnitude of EV/ magnitude of IRC |
| Safety Index | Up to 12 months | Safety Index defined as CDVA at the time point, when the stability of MRSE is reached, divided by CDVA at baseline (CDVA VX / CDVA V1). |
| Number of Adverse Events observed in the study | Up to 12 months. | Complications, including all related (Serious) Adverse Events, during surgery day and follow-up. |
| Number of Device defects observed in the study | Up to 12 months | Number of device defects observed during the clinical trial. |
| Vector analysis (CR) | Assessed at 3 months, 6 months, 9 months and 12 months post surgery. | Assessment of change in the Correction Rate during follow up; assessed until the MRSE stability is reached. Correction Ratio (CR) CR = magnitude of SIRC / magnitude of IRC |
| Predictability of MRSE | Up to 12 months | Percentage of eyes achieving MRSE within ± 1.00 D and within ± 0.50 D of the intended outcome at the point at which MRSE stability is achieved. |
| Efficacy Index | Up to 12 months | Efficacy Index is defined as UCDVA at the time point, when stability of MRSE is reached, divided by CDVA at baseline: (UCDVA VX /CDVA V1). Note: X corresponds to the visit, when stability of MRSE will have been reached. The Efficacy Index being above the efficacy cut-off level 0.8 indicates loss of less than two lines of UCDVA |
Countries
China
Contacts
Primary ContactOlga Grossenbacher, MD, PhD
Outcome results
None listed