Myopic AstigmatismNCT05229133
Efficacy and Safety of CLEAR in Myopia and Astigmatism in Chinese Population
A study testing CLEAR in people with Myopic Astigmatism, run by Ziemer Ophthalmic Systems AG at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopic Astigmatism
- What is being tested?
- CLEAR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 4 sitesChina
- Study dates
- 29 Nov 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Not yet recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality
Changbin Zhai, MD, 136 0108 9269
Changbin Zhai, MD
- Not yet recruiting
Ineye Hospital of Chengdu University of TCM
Chengdu, Sichuan
Yuehua Zhou, MD, 139 1083 6019
Yuehua Zhou, MD
- Not yet recruiting
Guangzhou Aier Eye Hospital
Guangzhou, Guangdong
Zheng Wang, MD, 139 0300 2594
Zheng Wang, MD
- Recruiting
Eye Hospital, WMU
Wenzhou, Zhejiang
Shi-hao Chen, MD, 139 6887 8892
Shi-hao Chen, MD
About this study
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
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.
Read more
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
- Being tested
- CLEAR
- Keywords
- CLEAR, Ziemer, FEMTO LDV, Lenticule, Myopic astigmatism
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLEARDevice
Also called Corneal lenticule extraction for advanced refractive correction
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CLEAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (13)
Stability of MRSE
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.
Measured: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
Predictability of MRSE
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.
Measured: Up to 12 months
Efficacy Index
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
Measured: Up to 12 months
Stability of MRCYL
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
Measured: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
Predictability of MRCYL
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.
Measured: Up to 12 months
Vector analysis (IRC)
Intended Refractive Correction Vector (IRC) IRC = Preoperative cylinder - Target (attempted) cylinder
Measured: Pre-operative
Vector analysis (SIRC)
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
Measured: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
Vector analysis (EV)
Assessment of change in the Error Vector during follow up; assessed until the MRSE stability is reached.
Error Vector (EV) EV = IRC - SIRC
Measured: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
Vector analysis (CR)
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
Measured: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
Vector analysis (ER)
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
Measured: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
Safety Index
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).
Measured: Up to 12 months
Number of Adverse Events observed in the study
Complications, including all related (Serious) Adverse Events, during surgery day and follow-up.
Measured: Up to 12 months.
Number of Device defects observed in the study
Number of device defects observed during the clinical trial.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start29 Nov 2021
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopic AstigmatismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziemer Ophthalmic Systems AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Shi-hao Chen, MD, Principal investigator, Eye Hospital, WMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229133
- Sponsor's protocol ID
- CPFLM-0008-CN-01
- Status last verified
- Dec 2021
- First submitted
- 22 Dec 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05229133
- Acronym / sponsor ID
- CPFLM-0008-CN-01
- Conditions
- Myopic Astigmatism
- Keywords
- CLEAR, Ziemer, FEMTO LDV, Lenticule, Myopic astigmatism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Ziemer Ophthalmic Systems AGIndustry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Refractive correction using CLEAR | Experimental | Device: CLEARSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLEARAlso: Corneal lenticule extraction for advanced refractive correctionFEMTO 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. | Device | Refractive correction using CLEAR |
Primary outcome
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: 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.
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.
13 secondary outcomes
Stability of MRSE
Time frame: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
Predictability of MRSE
Time frame: Up to 12 months
Efficacy Index
Time frame: Up to 12 months
Stability of MRCYL
Time frame: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
Predictability of MRCYL
Time frame: Up to 12 months
Vector analysis (IRC)
Time frame: Pre-operative
Vector analysis (SIRC)
Time frame: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
Vector analysis (EV)
Time frame: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
Vector analysis (CR)
Time frame: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
Vector analysis (ER)
Time frame: Assessed at 3 months, 6 months, 9 months and 12 months post surgery.
Safety Index
Time frame: Up to 12 months
Number of Adverse Events observed in the study
Time frame: Up to 12 months.
Number of Device defects observed in the study
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shi-hao Chen, MD principal investigator
Eye Hospital, WMU
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLEAR in people with Myopic Astigmatism, run by Ziemer Ophthalmic Systems AG at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olga Grossenbacher, MD, PhD (+41 79 671 67 25, olga.grossenbacher@ziemergroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCDVA (with cycloplegia) (time frame: Pre-operative). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.