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

NCT05229133 | Unknown

• 1 other identifier: CPFLM-0008-CN-01
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 4

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.

Conditions

Myopic Astigmatism

Keywords

CLEAR; Ziemer; FEMTO LDV; Lenticule; Myopic astigmatism

Outcome Measures

Primary Outcomes (9)

• 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

  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

Secondary Outcomes (13)

• Stability of MRSE

  Assessed at 3 months, 6 months, 9 months and 12 months post surgery.

• Predictability of MRSE

  Up to 12 months

• Efficacy Index

  Up to 12 months

• Stability of MRCYL

  Assessed at 3 months, 6 months, 9 months and 12 months post surgery.

• Predictability of MRCYL

  Up to 12 months

Study Arms (1)

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.

Device: CLEAR

Interventions

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.

Also known as: Corneal lenticule extraction for advanced refractive correction

Refractive correction using CLEAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically suitable for corneal refractive surgery
• Signed informed consent form
• Age ≥ 18 years
• Pre-operative BCVA ≥ 5.0 (corresponding to 20/20 as per Snellen chart lines)
• Myopia sphere from -0.5 D to -10.00 D
• Maximum cylinder diopter of -5.00 D
• Maximum resulting MRSE of -12.5 D
• Calculated residual stromal thickness ≥ 250 microns
• Non-contact IOP \< 21mmHg
• Stable refraction for the past year, as demonstrated by a change in manifest refraction spherical equivalent (MRSE) of ≤ 0.50 D
• A difference between cycloplegic refraction spherical equivalent and MRSE \< 0.75 D.
• 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.
• Patient willing and able to return to the study site for the follow-up visits, in the judgement of the investigator.

You may not qualify if:

• 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
• Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light
• Residual, recurrent, or active ocular disease or corneal abnormality (including, but not limited to ocular herpes zoster or simplex, active infections and inflammation)
• History of ocular herpes simplex or herpes zoster keratitis
• Severe dry eye
• Glaucoma
• Nystagmus or hemofacial spasm preventing placement of the patient interface
• Previous corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes
• Unstable central keratometry readings
• Mesopic pupil diameter \> 8.0 mm
• Keratometry readings via Sim-K values less than 40.00 D
• Allergy to medications required in surgery, pre- and post-operative treatment
• Keratoconus or keratectasia, including patients with suspicion of keratoconus on corneal topography
• 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
• Known psychotic disorders associated with delusions (e.g. schizophrenia)

Sponsors & Collaborators

• Ziemer Ophthalmic Systems AG: lead
• Tigermed Consulting Co., Ltd: collaborator

Study Sites (4)

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Guangzhou Aier Eye Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

Ineye Hospital of Chengdu University of TCM

Chengdu, Sichuan, China

NOT YET RECRUITING

Eye Hospital, WMU

Wenzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Shi-hao Chen, MD

  Eye Hospital, WMU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Grossenbacher, MD, PhD

CONTACT

+41 79 671 67 25; olga.grossenbacher@ziemergroup.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: February 8, 2022
• Study Start: November 29, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: February 8, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)