Status:
UNKNOWN
Efficacy and Safety of CLEAR in Myopia and Astigmatism in Chinese Population
Lead Sponsor:
Ziemer Ophthalmic Systems AG
Collaborating Sponsors:
Tigermed Consulting Co., Ltd
Conditions:
Myopic Astigmatism
Eligibility:
All Genders
18+ years
Phase:
NA
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 obje...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- 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
Key Trial Info
Start Date :
November 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT05229133
Start Date
November 29 2021
End Date
March 1 2023
Last Update
February 8 2022
Active Locations (4)
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1
Beijing Tongren Hospital
Beijing, Beijing Municipality, 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