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MyopiaNCT04426175

Z8 OCT-controlled 2D vs 3D LASIK

A study testing 2D and 3D cutting method using a low energy Femtosecond laser LDV Z8 for LASIK flap cutting in people with Myopia and Astigmatism, run by Zentrumsehstarke Hamburg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to test the hypothesis that OCT-guided 110 µm targeted flaps will result in accurate, predictable, and precise thickness flaps, with low complication rates when performed and compared using both 2D and 3D flap geometry applications and how it correlated to visual experience and quality of… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Myopia, Astigmatism
What is being tested?
2D and 3D cutting method using a low energy Femtosecond laser LDV Z8 for LASIK flap cutting
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteGermany
Study dates
5 Dec 2019to 23 Apr 2020
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Key inclusion criteria as described by the German Commission for Refractive Surgery (KRC) are:
  • The recommended range of application for the correction of myopia is up to -8.00 D and for the correction of astigmatism up to 5.00 D.
  • The limited for LASIK correction of myopia is up to -10.00 D and correction of astigmatism up to 6.00 D. If myopic astigmatism is to be corrected, the values for myopia and astigmatism must be added together.
  • The recommended range for correction of hyperopia is up to 3.00 D. Up to 4.00 D is the range of limited application for hyperopia.
  • Age ≥18 years with stable eyesight for over 12 months.

Who cannot join

  • Key exclusion criteria as described by the German Commission for Refractive Surgery (KRC):
  • preoperative corneal thickness less than 480 μm
  • predicted stromal thickness under the flap after ablation of less than 250 μm
  • chronic progressive corneal disease and forme fruste keratoconus
  • surgery before the age of 18 years
  • symptomatic cataract
Show all 11Show fewer
  • Glaucoma with a marked loss of visual field
  • Exudative macular degeneration.
  • Concurrent participation in another ophthalmological clinical study
  • Undergone former eye surgery
  • Contact lens wear within the two weeks prior to commencement of preoperative measurements

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Zentrumsehstärke

    Hamburg, 20251

Other trials in Germany

About this study

Official title: Precision of 2D vs 3D Low Energy Femto-LASIK: Intraoperative and Postoperative OCT-based Study

The aim of this study was to test the hypothesis that OCT-guided 110 µm targeted flaps will result in accurate, predictable, and precise thickness flaps, with low complication rates when performed and compared using both 2D and 3D flap geometry applications and how it correlated to visual experience and quality of life responses during the early postoperative period.

Read the detailed description

It has been postulated that it is possible with the Ziemer Femtosecond LDV laser system to create reproducible flaps in terms of thickness and predictability. The aim of this study was to test the hypothesis that OCT-guided 110 µm targeted flaps will result in accurate, predictable, and precise thickness flaps, with low complication rates when performed and compared using both 2D and 3D flap geometry applications. Patient-reported outcomes are increasingly incorporated into clinical trials as they provide access to valuable information on the physical experience of the patient during and after the treatment. A questionnaire will therefore also be introduced in this study to evaluate how well self-reported pain, visual experience, and quality of life responses are correlated with flap geometries in both groups during the early postoperative period. The study holds direct medical benefit to the patient in this that they received an immediate improvement in his/her unaided vision. Moreover, the patient's participation contributes to the medical knowledge about the use of femtosecond lasers for refractive surgery, in particular in view of the use of intraoperative OCT visualization tools. The patients will gain access to the newest technology available for refractive surgery namely a low pulse energy high-frequency femtosecond laser.

Conditions
Myopia, Astigmatism
Being tested
2D and 3D cutting method using a low energy Femtosecond laser LDV Z8 for LASIK flap cutting
Keywords
Femtosecond Laser Assisted Laser in Situ Keratomileusis, LASIK, FEMTO LDV Z8
Medical subject headings
Myopia, Astigmatism

What participants receive

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

  • 2D and 3D cutting method using a low energy Femtosecond laser LDV Z8 for LASIK flap cuttingDevice

    2D and 3D cutting methods were randomly used in same subjects

Study groups in NCT04426175
Study groupRoleWhat they receive
2D LASIKExperimentalWith the 2D method, the flap resection is created in a planar mode (xy-plane), without vertical cut, at the requested depth.
Receives: Device: 2D and 3D cutting method using a low energy Femtosecond laser LDV Z8 for LASIK flap cutting
3D LASIKExperimentalWith the 3D method, the flap resection is done in a three-dimensional mode, at the requested depth, with the requested diameter and the desired border (side cut) angle
Receives: Device: 2D and 3D cutting method using a low energy Femtosecond laser LDV Z8 for LASIK flap cutting

What is being measured

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

  1. Predictability of central flap thickness in OCT-controlled 110 µm LASIK

    Analyze central flap thickness in OCT-controlled 110 µm LASIK and to report on intended versus achieved flap thickness of one group with a 2D flap geometry in one eye and another group with a 3D flap geometry in the contralateral eye. All OCT measurements will be done in micron metres (µm).

    Measured: 1 month postoperatively

Secondary outcomes (7)

  1. Comparison of intraoperative flap thickness with pre- and postoperative results

    Measurement of corneal thickness pre flap creation (Corneal Pachymetry measurements expressed in µm indicate the thickness of the cornea before flap was created. This measurement will serve as the baseline measurement. Pachymetry measured again after the flap was created and lifted by means of optical and ultrasonic pachymetry(µm) for both groups and to be compare with postoperative AS-OCT measurements also measured in µm.This will indicate how accurate the intraoperative flap thickness compare to the 1 week and 1 month thickness measurements as swelling and inflammatory processes could influence postoperative measurements.

    Measured: 1 week, 1 month

  2. Postoperative planarity

    Assessment of several measurements taken along the corneal cut on superior, nasal, inferior and temporal points in order to compare the uniformity of the cut between 2D vs 3D geometries. Measurments will be done by means of AS-OCT,measured in µm units.Measurements at two different follow up periods will be analyzed and compared in order to rule out the role that inflammation could possibly play.

    Measured: 1 week, 1 month

  3. Intraoperative flap morphology

    Observations that are defined by different scales in order to report on important features pertaining to 2D and 3D intraoperative flap geometries eg. the presence and extent of opaque bubble layer (OBL), ease of flap lifting and stromal bed quality in both groups . Intraoperative flap morphology assessment to be done as soon as the flap was created in terms of presence of an opaque bubble layer (no OBL, 30-40% of flap surface, >40% of flap surface). Once the flap was lifted to report on ease of flap lifting (easy/sticky/can not lift) and to describe the stromal bed quality (smooth,tissue bridges, rastered, lines).

    Measured: During surgery

  4. Postoperative flap properties

    Evaluate flap properties by means of slit lamp biomicroscopy examination. The flap's visual appearance seen with the slit lamp to be described and documented as per the suggested scales during 2 specified follow up visits in terms of edge quality and visibility ('yes/no' If yes= extreme fine line, distinct line or irregular edge), border shape (round, irregular) and interface quality (smooth, lines, cobblestones, grids, microstriae) and be compared between flap geometries (2D and 3D flaps).

    Measured: 1 week, 1 month

  5. Visual outcomes

    Compare pre- and postoperative visual acuity (UDVA, CDVA) measurements by means of a Snellen Visual Acuity chart and be expressed in decimal that will be converted to logMar units for the purpose of statistical analysis.

    Measured: 1 day, 1 week, 1 month

  6. Patient reported Outcomes: early recovery period

    Conduct a non validated Patient Reported Outcome (PRO) questionnaire adopted and based on the 'Brief Pain Inventory' questionnaire [Porela-Tiihonen] to assess patient's early visual perceptions and pain experience related to their own functional status and wellbeing and to compare between the two eyes since each undergone different cutting geometry (2D vs 3D) methods.

    Measured: 1 day, 2Day, 1 week follow up

  7. Complications

    Report and document any intra- and postoperative complications that may occur during the time of the procedure or at the 1 month follow up visit.

    Measured: Intra- and postoperatively up to 1 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2020
  2. Study start5 Dec 2019
  3. Primary completion23 Apr 2020
  4. Study completion23 Apr 2020

Resources

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
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04426175
Sponsor's protocol ID
CPFEM-0007-DE
Status last verified
Jun 2020
First submitted
3 Jun 2020
Last updated
11 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It is not clear yet to what extend IPD will be implemented. Patient privacy and confidentiality are the most important factors to consider. We consider sharing limited information upon request.

Publications

  • Huhtala A, Pietila J, Makinen P, Uusitalo H. Femtosecond lasers for laser in situ keratomileusis: a systematic review and meta-analysis. Clin Ophthalmol. 2016 Mar 7;10:393-404. doi: 10.2147/OPTH.S99394. eCollection 2016.

    PubMed 27022236

  • Eldaly ZH, Abdelsalam MA, Hussein MS, Nassr MA. Comparison of Laser In Situ Keratomileusis Flap Morphology and Predictability by WaveLight FS200 Femtosecond Laser and Moria Microkeratome: An Anterior Segment Optical Coherence Tomography Study. Korean J Ophthalmol. 2019 Apr;33(2):113-121. doi: 10.3341/kjo.2018.0035.

    PubMed 30977320

  • Pajic B, Vastardis I, Pajic-Eggspuehler B, Gatzioufas Z, Hafezi F. Femtosecond laser versus mechanical microkeratome-assisted flap creation for LASIK: a prospective, randomized, paired-eye study. Clin Ophthalmol. 2014 Sep 22;8:1883-9. doi: 10.2147/OPTH.S68124. eCollection 2014.

    PubMed 25284975

  • Tomita M, Chiba A, Matsuda J, Nawa Y. Evaluation of LASIK treatment with the Femto LDV in patients with corneal opacity. J Refract Surg. 2012 Jan;28(1):25-30. doi: 10.3928/1081597X-20111213-01. Epub 2011 Dec 19.

    PubMed 22185466

  • Pietila J, Huhtala A, Makinen P, Uusitalo H. Flap characteristics, predictability, and safety of the Ziemer FEMTO LDV femtosecond laser with the disposable suction ring for LASIK. Eye (Lond). 2014 Jan;28(1):66-71. doi: 10.1038/eye.2013.244. Epub 2013 Nov 15.

    PubMed 24232315

  • Pietila J, Huhtala A, Makinen P, Salmenhaara K, Uusitalo H. Laser-assisted in situ keratomileusis flap creation with the three-dimensional, transportable Ziemer FEMTO LDV model Z6 I femtosecond laser. Acta Ophthalmol. 2014 Nov;92(7):650-5. doi: 10.1111/aos.12333. Epub 2013 Dec 26.

    PubMed 24373615

  • Porela-Tiihonen S, Kaarniranta K, Kokki M, Purhonen S, Kokki H. A prospective study on postoperative pain after cataract surgery. Clin Ophthalmol. 2013;7:1429-35. doi: 10.2147/OPTH.S47576. Epub 2013 Jul 15.

    PubMed 23885165

Questions about this trial

What is this clinical trial studying?

A study testing 2D and 3D cutting method using a low energy Femtosecond laser LDV Z8 for LASIK flap cutting in people with Myopia and Astigmatism, run by Zentrumsehstarke Hamburg at 1 site in Germany.

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 5 inclusion and 11 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: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Predictability of central flap thickness in OCT-controlled 110 µm LASIK (time frame: 1 month postoperatively). 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 NCT04426175, which also lists 7 linked publications.

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 11 Jun 2020.

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Z8 OCT-controlled 2D vs 3D LASIK (NCT04426175) | AzTrials