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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Ziemer Ophthalmic Systems AG
- Enrollment
- 215
- Locations
- 4
- Primary Endpoint
- UCDVA (with cycloplegia)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
- •3 months before the inclusion have taken systemic medication likely to negatively affect wound healing, such as glucocorticosteroide or antimetabolites
- •Severe dry eye
- •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
- •At the time of inclusion, participation in other medical device clinical trials within one month or in drug clinical trials within 3 months
- •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)
- •Woman who is pregnant or nursing
Arms & Interventions
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.
Intervention: CLEAR (Device)
Outcomes
Primary Outcomes
UCDVA (with cycloplegia)
Time Frame: 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)
Time Frame: 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
Time Frame: 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.
UCDVA
Time Frame: 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.
UCDVA
Time Frame: 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.
UCDVA
Time Frame: 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.
UCDVA
Time Frame: 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.
UCDVA
Time Frame: 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.
UCDVA
Time Frame: 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.
Secondary Outcomes
- Predictability of MRSE(Up to 12 months)
- Efficacy Index(Up to 12 months)
- Vector analysis (SIRC)(Assessed at 3 months, 6 months, 9 months and 12 months post surgery.)
- Vector analysis (EV)(Assessed at 3 months, 6 months, 9 months and 12 months post surgery.)
- Vector analysis (CR)(Assessed at 3 months, 6 months, 9 months and 12 months post surgery.)
- Stability of MRSE(Assessed at 3 months, 6 months, 9 months and 12 months post surgery.)
- Stability of MRCYL(Assessed at 3 months, 6 months, 9 months and 12 months post surgery.)
- Predictability of MRCYL(Up to 12 months)
- Vector analysis (IRC)(Pre-operative)
- Safety Index(Up to 12 months)
- Number of Adverse Events observed in the study(Up to 12 months.)
- Vector analysis (ER)(Assessed at 3 months, 6 months, 9 months and 12 months post surgery.)
- Number of Device defects observed in the study(Up to 12 months)