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Z8 OCT-controlled 2D vs 3D LASIK

Primary Purpose

Myopia, Astigmatism

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Myopia focused on measuring Femtosecond Laser Assisted Laser in Situ Keratomileusis, LASIK, FEMTO LDV Z8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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
Glaucoma with a marked loss of visual field
Exudative macular degeneration.
Concurrent participation in another ophthalmological clinical study

Exclusion criteria irrespective of the KRC criteria:

Undergone former eye surgery
Contact lens wear within the two weeks prior to commencement of preoperative measurements

Sites / Locations

Zentrumsehstärke

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

2D LASIK

3D LASIK

Arm Description

With the 2D method, the flap resection is created in a planar mode (xy-plane), without vertical cut, at the requested depth.

With 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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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.

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).

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).

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.

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.

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.

Full Information

NCT ID

NCT04426175

First Posted

June 3, 2020

Last Updated

June 8, 2020

Sponsor

Zentrumsehstarke Hamburg

1. Study Identification

Unique Protocol Identification Number

NCT04426175

Brief Title

Z8 OCT-controlled 2D vs 3D LASIK

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

December 5, 2019 (Actual)

Primary Completion Date

April 23, 2020 (Actual)

Study Completion Date

April 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zentrumsehstarke Hamburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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 life responses during the early postoperative period.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia, Astigmatism

Keywords

Femtosecond Laser Assisted Laser in Situ Keratomileusis, LASIK, FEMTO LDV Z8

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

2D LASIK

Arm Type

Experimental

Arm Description

With the 2D method, the flap resection is created in a planar mode (xy-plane), without vertical cut, at the requested depth.

Arm Title

3D LASIK

Arm Type

Experimental

Arm Description

With 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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

1 month postoperatively

Secondary Outcome Measure Information:

Title

Comparison of intraoperative flap thickness with pre- and postoperative results

Description

Time Frame

1 week, 1 month

Title

Postoperative planarity

Description

Time Frame

1 week, 1 month

Title

Intraoperative flap morphology

Description

Time Frame

During surgery

Title

Postoperative flap properties

Description

Time Frame

1 week, 1 month

Title

Visual outcomes

Description

Time Frame

1 day, 1 week, 1 month

Title

Patient reported Outcomes: early recovery period

Description

Time Frame

1 day, 2Day, 1 week follow up

Title

Complications

Description

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.

Time Frame

Intra- and postoperatively up to 1 month follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 Glaucoma with a marked loss of visual field Exudative macular degeneration. Concurrent participation in another ophthalmological clinical study Exclusion criteria irrespective of the KRC criteria: Undergone former eye surgery Contact lens wear within the two weeks prior to commencement of preoperative measurements

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephan Linke, MD

Organizational Affiliation

Zentrumsehstarke Hamburg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zentrumsehstärke

City

Hamburg

ZIP/Postal Code

20251

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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.

Citations:

PubMed Identifier

27022236

Citation

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.

Results Reference

background

PubMed Identifier

30977320

Citation

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.

Results Reference

background

PubMed Identifier

25284975

Citation

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.

Results Reference

background

PubMed Identifier

22185466

Citation

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.

Results Reference

background

PubMed Identifier

24232315

Citation

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.

Results Reference

background

PubMed Identifier

24373615

Citation

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.

Results Reference

background

PubMed Identifier

23885165

Citation

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.

Results Reference

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Z8 OCT-controlled 2D vs 3D LASIK

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