Z8 OCT-controlled 2D vs 3D LASIK

NCT ID: NCT04426175

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-05
• Study Completion Date: 2020-04-23

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.

Conditions

Myopia; Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2D LASIK

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

3D LASIK

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zentrumsehstarke Hamburg

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan Linke, MD

Role: PRINCIPAL_INVESTIGATOR

Zentrumsehstarke Hamburg

Locations

Zentrumsehstärke

Hamburg, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 27022236 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30977320 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25284975 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22185466 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24232315 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24373615 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23885165 (View on PubMed)

Other Identifiers

CPFEM-0007-DE

Identifier Type: -

Identifier Source: org_study_id