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| Name | Class |
|---|---|
| Tigermed Consulting Co., Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refractive correction using CLEAR | Experimental | Subjects 18+ years old with myopic (-0.50 to -10.00 D) astigmatism (up to -5.00 D) treated bilaterally with FEMTO LDV Z8 using CLEAR application. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLEAR | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| UCDVA (with cycloplegia) | 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. | Pre-operative |
| UCDVA (without cycloplegia) | 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. | Pre-operative |
| UCDVA | 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. | day 1 |
| UCDVA | 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. | 1 week |
| UCDVA | 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. | 1 month |
| UCDVA |
| Measure | Description | Time Frame |
|---|---|---|
| Stability of MRSE | The percentage of eyes with:
| Assessed at 3 months, 6 months, 9 months and 12 months post surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olga Grossenbacher, MD, PhD | Contact | +41 79 671 67 25 | olga.grossenbacher@ziemergroup.com |
| Name | Affiliation | Role |
|---|---|---|
| Shi-hao Chen, MD | Eye Hospital, WMU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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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. |
| 3 months |
| UCDVA | 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. | 6 months |
| UCDVA | 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. | 9 months |
| UCDVA | 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. | 12 months |
| Predictability of MRSE |
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. |
| Up to 12 months |
| Efficacy Index | 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 | Up to 12 months |
| Stability of MRCYL | 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 | Assessed at 3 months, 6 months, 9 months and 12 months post surgery. |
| Predictability of MRCYL | 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. | Up to 12 months |
| Vector analysis (IRC) | Intended Refractive Correction Vector (IRC) IRC = Preoperative cylinder - Target (attempted) cylinder | Pre-operative |
| Vector analysis (SIRC) | 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 | Assessed at 3 months, 6 months, 9 months and 12 months post surgery. |
| Vector analysis (EV) | Assessment of change in the Error Vector during follow up; assessed until the MRSE stability is reached. Error Vector (EV) EV = IRC - SIRC | Assessed at 3 months, 6 months, 9 months and 12 months post surgery. |
| Vector analysis (CR) | 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 | Assessed at 3 months, 6 months, 9 months and 12 months post surgery. |
| Vector analysis (ER) | 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 | Assessed at 3 months, 6 months, 9 months and 12 months post surgery. |
| Safety Index | 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). | Up to 12 months |
| Number of Adverse Events observed in the study | Complications, including all related (Serious) Adverse Events, during surgery day and follow-up. | Up to 12 months. |
| Number of Device defects observed in the study | Number of device defects observed during the clinical trial. | Up to 12 months |
| Guangzhou Aier Eye Hospital | Not yet recruiting | Guangzhou | Guangdong | China |
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| Ineye Hospital of Chengdu University of TCM | Not yet recruiting | Chengdu | Sichuan | China |
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| Eye Hospital, WMU | Recruiting | Wenzhou | Zhejiang | China |
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