Efficacy and Safety of CLEAR in Myopia and Astigmatism in Chinese Population

Sponsor
Ziemer Ophthalmic Systems AG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05229133
Collaborator
Tigermed Consulting Co., Ltd (Industry)
215
4
1
15
53.8
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CLEAR
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
215 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicentre, Prospective, Single-arm Clinical Trial to Evaluate Efficacy and Safety of Femtosecond Laser Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) in Myopia and Astigmatism in Chinese Population
Actual Study Start Date :
Nov 29, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Refractive correction using CLEAR

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.

Device: CLEAR
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.
Other Names:
  • Corneal lenticule extraction for advanced refractive correction
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. UCDVA [1 week]

      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.

    5. UCDVA [1 month]

      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. UCDVA [3 months]

      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.

    7. UCDVA [6 months]

      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.

    8. UCDVA [9 months]

      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. UCDVA [12 months]

      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 Outcome Measures

    1. 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.

    2. 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.

    3. 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

    4. 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

    5. 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.

    6. Vector analysis (IRC) [Pre-operative]

      Intended Refractive Correction Vector (IRC) IRC = Preoperative cylinder - Target (attempted) cylinder

    7. 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

    8. 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

    9. 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

    10. 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

    11. 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).

    12. 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.

    13. Number of Device defects observed in the study [Up to 12 months]

      Number of device defects observed during the clinical trial.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Tongren Hospital Beijing Bei-jing China
    2 Guangzhou Aier Eye Hospital Guangzhou Guangdong China
    3 Ineye Hospital of Chengdu University of TCM Chengdu Sichuan China
    4 Eye Hospital, WMU Wenzhou Zhejiang China

    Sponsors and Collaborators

    • Ziemer Ophthalmic Systems AG
    • Tigermed Consulting Co., Ltd

    Investigators

    • Principal Investigator: Shi-hao Chen, MD, Eye Hospital, WMU

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ziemer Ophthalmic Systems AG
    ClinicalTrials.gov Identifier:
    NCT05229133
    Other Study ID Numbers:
    • CPFLM-0008-CN-01
    First Posted:
    Feb 8, 2022
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ziemer Ophthalmic Systems AG
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 8, 2022