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MyopiaNCT05484531

CLEAR Procedure in Myopia and Astigmatism - Registry Study

An observational study of Myopia and Astigmatism, run by Ziemer Ophthalmic Systems AG.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Multicenter, prospective, single-arm, observational, non-interventional post market clinical investigation (registry study) with the overall objective to assess safety and performance of CLEAR in a real world setting. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myopia, Astigmatism
What is being tested?
CLEAR
Type of treatment
Medical device
How many people
150 participants
Where
No sites listed yet
Study dates
Oct 2022to Apr 2024
How long will I take part?
12 Months
Phase
Observational
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

Study population: Adult subjects (clients of the ophthalmology clinic) enrolled in several European countries, scheduled to undergo refractive surgery to correct myopia AND/OR astigmatic myopia.

Formal inclusion/exclusion criteria are not applicable to the study at hand, due to its observational and non-interventional nature.

Patients treated with the CLEAR application using FEMTO LDV Z8, enrolled in the study are expected not to present with any of the market-approved device's contraindications:

  • Residual thickness of stromal bed that is less than 250 microns from the corneal endothelium
  • Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration
  • Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect)
  • Irregular or unstable (distorted/not clear) corneal mires on central keratometry images
  • Severe dry eye
  • Active eye infection or inflammation
  • Recent herpes eye infection or problems resulting from past infection
  • Active autoimmune disease or connective tissue disease
  • Uncontrolled diabetes
  • High IOP fluctuations that are not controlled under medications and continuous visual field damage

Note 1: The above listed contraindications are a subject to change, as per PMS, risk management or other regulatory feedback, and will be covered and communicated to the participating investigators in the prospective updates of the Operator's Manual.

Note 2: Only eyes of patients treated bilaterally shall be included in the analysis covered by this registry study.

Note 3: Patient's targeted for "monovision" shall not be included in the analysis covered by this registry study.

Note 4: Clinical cases, that despite presenting any of the above listed contraindications, would still be enrolled in the study by the Investigator, may be subject to a sub-group statistical analysis.

About this study

Official title: A Multicentre, Prospective, Registry Study for Femtosecond Laser Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) Procedure in Myopia and Astigmatism

Multicenter, prospective, single-arm, observational, non-interventional post market clinical investigation (registry study) with the overall objective to assess safety and performance of CLEAR in a real world setting.

Conditions
Myopia, Astigmatism
Being tested
CLEAR
Keywords
CLEAR, Ziemer, FEMTO LDV, Astigmatism, Myopia, Lenticule extraction
Medical subject headings
Myopia, Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CLEARDevice

    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 groups in NCT05484531
Study groupRoleWhat they receive
CLEARAdult subjects suffering from myopia AND/OR astigmatism treated with CLEAR.
Receives: Device: CLEAR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better

    Uncorrected Distance Visual Accuity assessment

    Measured: 1 day post surgery

  2. The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better

    Uncorrected Distance Visual Accuity assessment

    Measured: 1 month post surgery

  3. The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better

    Uncorrected Distance Visual Accuity assessment

    Measured: 3 months post surgery

  4. The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better

    Uncorrected Distance Visual Accuity assessment

    Measured: 6 months post surgery

  5. The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better

    Uncorrected Distance Visual Accuity assessment

    Measured: 12 months post surgery

Secondary outcomes (24)

  1. Refractive target [D]

    Expressed as MRSE

    Measured: Preoperative assessment

  2. Corrected distance visual accuity (CDVA)

    Values expressed as per Snellen Chart lines

    Measured: 1 day post surgery

  3. Corrected distance visual accuity (CDVA)

    Values expressed as per Snellen Chart lines

    Measured: 1 month post surgery

  4. Corrected distance visual accuity (CDVA)

    Values expressed as per Snellen Chart lines

    Measured: 3 months post surgery

  5. Corrected distance visual accuity (CDVA)

    Values expressed as per Snellen Chart lines

    Measured: 6 months post surgery

  6. Corrected distance visual accuity (CDVA)

    Values expressed as per Snellen Chart lines

    Measured: 12 months post surgery

  7. Refraction [SphD, CylD, Axis]

    Examination of both subjective and objective refraction.

    Values may be expressed as MRSE.

    Measured: 1 day post surgery

  8. Refraction [SphD, CylD, Axis]

    Examination of both subjective and objective refraction.

    Values may be expressed as MRSE.

    Measured: 1 month post surgery

  9. Refraction [SphD, CylD, Axis]

    Examination of both subjective and objective refraction.

    Values may be expressed as MRSE.

    Measured: 3 months post surgery

  10. Refraction [SphD, CylD, Axis]

    Examination of both subjective and objective refraction.

    Values may be expressed as MRSE.

    Measured: 6 months post surgery

  11. Refraction [SphD, CylD, Axis]

    Examination of both subjective and objective refraction.

    Values may be expressed as MRSE.

    Measured: 12 months post surgery

  12. Assessment of changes in corneal topography [um]

    Following parameters will be assessed:

    • Simulated Keratometry (SimK) values
    • Average SimK (SimKavg)
    • Flat SimK (SimKf)
    • Steep SimK (SimKs)
    • Astigmatism [D, °]
    • Corneal anterior surface eccentricity

    Measured: Baseline and 1 month

  13. Assessment of changes in corneal topography [um]

    Following parameters will be assessed:

    • Simulated Keratometry (SimK) values
    • Average SimK (SimKavg)
    • Flat SimK (SimKf)
    • Steep SimK (SimKs)
    • Astigmatism [D, °]
    • Corneal anterior surface eccentricity

    Measured: Baseline and 3 months

  14. Assessment of changes in corneal topography [um]

    Following parameters will be assessed:

    • Simulated Keratometry (SimK) values
    • Average SimK (SimKavg)
    • Flat SimK (SimKf)
    • Steep SimK (SimKs)
    • Astigmatism [D, °]
    • Corneal anterior surface eccentricity

    Measured: Baseline and 6 months

  15. Assessment of changes in corneal topography [um]

    Following parameters will be assessed:

    • Simulated Keratometry (SimK) values
    • Average SimK (SimKavg)
    • Flat SimK (SimKf)
    • Steep SimK (SimKs)
    • Astigmatism [D, °]
    • Corneal anterior surface eccentricity

    Measured: Baseline and 12 months

  16. Assessment of changes in corneal pachymetry [um]

    Following parameters will be assessed:

    • Central corneal thickness [µm]
    • Thinnest corneal point [µm]

    Measured: Baseline and 1 month

  17. Assessment of changes in corneal pachymetry [um]

    Following parameters will be assessed:

    • Central corneal thickness [µm]
    • Thinnest corneal point [µm]

    Measured: Baseline and 3 months

  18. Assessment of changes in corneal pachymetry [um]

    Following parameters will be assessed:

    • Central corneal thickness [µm]
    • Thinnest corneal point [µm]

    Measured: Baseline and 6 months

  19. Assessment of changes in corneal pachymetry [um]

    Following parameters will be assessed:

    • Central corneal thickness [µm]
    • Thinnest corneal point [µm]

    Measured: Baseline and 12 months

  20. Assessment of changes in "white to white" [mm]

    Measured: Baseline and 1 month

  21. Assessment of changes in "white to white" [mm]

    Measured: Baseline and 3 months

  22. Assessment of changes in "white to white" [mm]

    Measured: Baseline and 6 months

  23. Assessment of changes in "white to white" [mm]

    Measured: Baseline and 12 months

  24. Number of Adverse Events observed in the study

    Following events will be recorded:

    • Adverse device effects (ADEs)
    • Surgical complications (intraoperative and post-operative)

    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.

  1. First posted2 Aug 2022
  2. Study startOct 2022 (estimated)
  3. Primary completionApr 2024 (estimated)
  4. Study completionApr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05484531
Sponsor's protocol ID
CPFEM-0011-EU
Status last verified
Jul 2022
First submitted
29 Jul 2022
Last updated
2 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Myopia and Astigmatism, run by Ziemer Ophthalmic Systems AG.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of eyes that achieve Uncorrected Distance Visual Acuity (UCDVA) of 20/40 (as per Snellen chart lines) or better (time frame: 1 day post surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05484531.

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 2 Aug 2022.

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