Clinical trial NCT05229133: Efficacy and Safety of CLEAR in Myopia and Astigmatism in Chinese Population
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopic Astigmatism
Keywords: CLEAR
Ziemer
FEMTO LDV
Lenticule
Myopic astigmatism
Lead sponsor: Ziemer Ophthalmic Systems AG
Sponsor class: INDUSTRY
Collaborators: name: Tigermed Consulting Co., Ltd
First posted: 2022-02-08
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: UCDVA (with cycloplegia)
timeFrame: Pre-operative
measure: UCDVA (without cycloplegia)
timeFrame: Pre-operative
measure: UCDVA
timeFrame: day 1
measure: UCDVA
timeFrame: 1 week
measure: UCDVA
timeFrame: 1 month
measure: UCDVA
timeFrame: 3 months
measure: UCDVA
timeFrame: 6 months
measure: UCDVA
timeFrame: 9 months
measure: UCDVA
timeFrame: 12 months
Secondary outcomes:
measure: Stability of MRSE
timeFrame: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
measure: Predictability of MRSE
timeFrame: Up to 12 months
measure: Efficacy Index
timeFrame: Up to 12 months
measure: Stability of MRCYL
timeFrame: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
measure: Predictability of MRCYL
timeFrame: Up to 12 months
measure: Vector analysis (IRC)
timeFrame: Pre-operative
measure: Vector analysis (SIRC)
timeFrame: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
measure: Vector analysis (EV)
timeFrame: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
measure: Vector analysis (CR)
timeFrame: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
measure: Vector analysis (ER)
timeFrame: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
measure: Safety Index
timeFrame: Up to 12 months
measure: Number of Adverse Events observed in the study
timeFrame: Up to 12 months.
measure: Number of Device defects observed in the study
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Bei-jing
city: Guangzhou
country: China
facility: Guangzhou Aier Eye Hospital
state: Guangdong
city: Chengdu
country: China
facility: Ineye Hospital of Chengdu University of TCM
state: Sichuan
city: Wenzhou
country: China
facility: Eye Hospital, WMU
state: Zhejiang
Study officials:
affiliation: Eye Hospital, WMU
name: Shi-hao Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: