Z8 OCT-controlled 2D vs 3D LASIK

NCT04426175 | Completed

• 1 other identifier: CPFEM-0007-DE
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Astigmatism

Keywords

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

Outcome Measures

Primary Outcomes (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).

  1 month postoperatively

Secondary Outcomes (7)

• Comparison of intraoperative flap thickness with pre- and postoperative results

  1 week, 1 month

• Postoperative planarity

  1 week, 1 month

• Intraoperative flap morphology

  During surgery

• Postoperative flap properties

  1 week, 1 month

• Visual outcomes

  1 day, 1 week, 1 month

Study Arms (2)

2D LASIK

EXPERIMENTAL

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

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

3D LASIK

EXPERIMENTAL

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

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

Interventions

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

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

2D LASIK; 3D LASIK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zentrumsehstarke Hamburg: lead

Study Sites (1)

Zentrumsehstärke

Hamburg, 20251, Germany

Location

Related Publications (7)

• 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.

  PMID: 27022236 BACKGROUND

• 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.

  PMID: 30977320 BACKGROUND

• 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.

  PMID: 25284975 BACKGROUND

• 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.

  PMID: 22185466 BACKGROUND

• 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.

  PMID: 24232315 BACKGROUND

• 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.

  PMID: 24373615 BACKGROUND

• 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.

  PMID: 23885165 BACKGROUND

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Stephan Linke, MD

  Zentrumsehstarke Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 11, 2020
• Study Start: December 5, 2019
• Primary Completion: April 23, 2020
• Study Completion: April 23, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)