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Femto-flap Versus SBK Flap,Predictability and Variability

Primary Purpose

Refractive Errors, Refractive Surgery

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Visumax Femto-flap
Sub Bowman's keratomileusis (SBK)-flap
Sponsored by
Suzan A Rattan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Errors focused on measuring Visumax, femtolasik, Sub Bowman keratomileusis(SBK), LASIK

Eligibility Criteria

20 Years - 38 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Having refractive errors range from -2 to- 6 DS and from -1 to -3.00DC.
  • They have stable refraction for at least one year prior to surgery.
  • Normal topography by Placido-Scheimpflug (Sirius, Costruzione Strumenti Oftalmici, Florence, Italia) and normal corneal epithelial map by Anterior segment-OCT system (Optovue Inc, Fremont, California, USA)

Exclusion Criteria:

  1. Patient with suspicious topography and or corneal epithelial map.
  2. Patient with corneal pachymetry below 500µm.
  3. Patients who have a history of previous ocular surgery or trauma.
  4. Patient with a current or previous history of herpes simplex or herpes zoster.
  5. Patient with severe dry eye, diabetes, thyrotoxicosis, and connective tissue diseases.
  6. Patient with Combined ocular diseases like retinal dystrophy or glaucoma.
  7. Patient with a history of contact lenses use was meant to stop the use of soft contact lenses for at least 2 weeks or hard type for at least 4 weeks before topography and other investigations were done.
  8. Patient who refrains from the required follow-up visits; have been excluded from the study.

    -

Sites / Locations

  • Eye Speciality private hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Visumax Femto-flap

Sub Bowman's keratomileusis (SBK )-Flap group

Arm Description

Fifty eyes of fifty patients with age range 20-38 years, with myopic astigmatism refractive errors, ranged from -2 to- 6 DS and from -1 to -3.00DC, with stable refraction for at least one year before the surgery, normal corneal topography, anterior and posterior segments examinations. Refractive surgery was planned for both eyes and they chose the Visumax Femto-LASIK after a complete explanation of all the possible complications, costs, and differences. The right eye of each patient was taken for analysis, LASIK flap thickness was measured six months after the procedures using the anterior segment OCT, at seven points (one central and 3 points at each side of the horizontal meridian). The three nasal points were located (1mm, 2mm, 3mm respectively) from the center, and the remaining three temporal points located again ( 1mm, 2mm, 3mm) from the center.

Fifty eyes of fifty patients with age range 20-38 years, with myopic astigmatism refractive errors, ranged from -2 to- 6 DS and from -1 to -3.00DC, with stable refraction for at least one year before the surgery, normal corneal topography, anterior and posterior segments examinations. They chose LASIK with mechanical SBK microkeratome surgical approach to be their refractive surgery for both eyes after all the possible complications, costs and differences had been explained clearly. The right eye of each patient was taken for analysis, LASIK flap thickness was measured six months after the procedures using the anterior segment OCT, at seven points (one central and 3 points at each side of the horizontal meridian). The three nasal points were located (1mm, 2mm, 3mm respectively) from the center, and the remaining three temporal points located again ( 1mm, 2mm, 3mm) from the center.

Outcomes

Primary Outcome Measures

Right eye corneal flap thickness was measured by optical coherence tomography(OCT).
The lasik flap thickness in the right eye in both groups were measured six months after the procedures using non touch method by anterior segment OCT without instillation of topical anaesthesia, at seven points in each eye (one central and 3 points at each sides of horizontal meridian).The three nasal points were located (1mm, 2mm, 3mm respectively) from the center and remaining three temporal points located again ( 1mm, 2mm, 3mm) from the center. Data from both groups were comparing to evaluate predictability and variability of the flap thickness.

Secondary Outcome Measures

Full Information

First Posted
December 22, 2020
Last Updated
July 19, 2021
Sponsor
Suzan A Rattan
search

1. Study Identification

Unique Protocol Identification Number
NCT04684888
Brief Title
Femto-flap Versus SBK Flap,Predictability and Variability
Official Title
Comparison of Corneal Flap Thickness Using Visumax Femto-Lasik With SubBowman Keratomileusis (SBK) Microkeratome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Suzan A Rattan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Laser Insitu keratomileusis (LASIK) has become the most popular procedure for refractive error correction. Lasik flap creation is the first and critical step during LASIK surgery because of its consensual effect on a residual stromal bed, corneal biomechanics, and hence the future risk of ectasia⁴.In the current study, we compared the Visumax FSL flap thickness predictability, accuracy, and variability with the flap created by single-use Moria SBK microkeratome.
Detailed Description
Flap creation techniques have evolved from the old manual procedure of mechanical microkeratome to the automated one with the use of microkeratome and more recently to Femto-laser procedure using a variety of machines. Authors have reported that the primary vision nearly the same despite the different methods of flap creation in the first 6 months post LASER vision correction. Others have reported that a thinner flap is associated with better primary vision and refractive outcomes. SBK (Sub Bowman Keratomileusis), is a procedure in which the Lasik flap is thinner, and has the advantage of leaving a sufficient stromal bed for safer excimer Laser ablation. There are five types of femtosecond Laser that were already approved currently for Lasik flap creation. The Zeiss (Visumax FSL ) which has been used in the current study uses 1043 nm, a repetition rate of 500 kHz, and 220-580 femtoseconds pulse duration. Each laser pulse produces micro-photo disruption in the tissue, contiguous few microns sized photo disruptions will create a continuous cut in the corneal tissue at precise preset position and depth. In the current study, the Visumax flap thickness predictability, accuracy, and variability were compared with the flap created by a single-use Moria SBK microkeratome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors, Refractive Surgery
Keywords
Visumax, femtolasik, Sub Bowman keratomileusis(SBK), LASIK

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Visumax Femto-flap
Arm Type
Active Comparator
Arm Description
Fifty eyes of fifty patients with age range 20-38 years, with myopic astigmatism refractive errors, ranged from -2 to- 6 DS and from -1 to -3.00DC, with stable refraction for at least one year before the surgery, normal corneal topography, anterior and posterior segments examinations. Refractive surgery was planned for both eyes and they chose the Visumax Femto-LASIK after a complete explanation of all the possible complications, costs, and differences. The right eye of each patient was taken for analysis, LASIK flap thickness was measured six months after the procedures using the anterior segment OCT, at seven points (one central and 3 points at each side of the horizontal meridian). The three nasal points were located (1mm, 2mm, 3mm respectively) from the center, and the remaining three temporal points located again ( 1mm, 2mm, 3mm) from the center.
Arm Title
Sub Bowman's keratomileusis (SBK )-Flap group
Arm Type
Active Comparator
Arm Description
Fifty eyes of fifty patients with age range 20-38 years, with myopic astigmatism refractive errors, ranged from -2 to- 6 DS and from -1 to -3.00DC, with stable refraction for at least one year before the surgery, normal corneal topography, anterior and posterior segments examinations. They chose LASIK with mechanical SBK microkeratome surgical approach to be their refractive surgery for both eyes after all the possible complications, costs and differences had been explained clearly. The right eye of each patient was taken for analysis, LASIK flap thickness was measured six months after the procedures using the anterior segment OCT, at seven points (one central and 3 points at each side of the horizontal meridian). The three nasal points were located (1mm, 2mm, 3mm respectively) from the center, and the remaining three temporal points located again ( 1mm, 2mm, 3mm) from the center.
Intervention Type
Procedure
Intervention Name(s)
Visumax Femto-flap
Intervention Description
Under topical anesthesia [Tetracaine eye drop 0.5%]. A-90 µm thick flap was done by using Visumax femtosecond laser. The flap hinge was set to be nasally placed. A nasal-hinge flap with 90 µm thickness, 8.8 mm flap diameter, and 90º side cut angles were created with 500 kHz Visumax FSL, 160 nJ energy [Carl Zeiss, Meditec, Germany]. The sphero- cylindrical refractive corrections with optical zone 6.5 mm and ablation zone 8.0 mm were done by excimer laser operating system [Carl Zeiss, Meditec, MEL 90, Germany]. Automatic iris registration and pupil-tracking system were activated before photoablation. The patient's eyes were examined postoperatively on a slit-lamp biomicroscope and all treatments that were given for home use have been explained in terms of frequency of instillation, possible side effects, and benefits before discharging them on the same day. Follow up visits were scheduled clearly on printed patients' discharging cards.
Intervention Type
Procedure
Intervention Name(s)
Sub Bowman's keratomileusis (SBK)-flap
Intervention Description
Under topical anesthesia [Tetracaine eye drop 0.5%] .A-90µm flaps done using Maria one use plus SBK mechanical microkeratome with a nasal located hinge. The sphero- cylindrical refractive corrections with optical zone 6.5 mm and ablation zone 8.0 mm were done by excimer laser operating system [Carl Zeiss, Meditec, MEL 90, Germany]. Automatic iris registration and pupil-tracking system were activated before photoablation. The patient's eyes were examined postoperatively on a slit-lamp biomicroscope and all treatments that were given for home use have been explained in terms of the frequency of instillation, possible side effects, and benefits before discharging them on the same day. Follow up visits were scheduled clearly on printed patients' discharging cards .
Primary Outcome Measure Information:
Title
Right eye corneal flap thickness was measured by optical coherence tomography(OCT).
Description
The lasik flap thickness in the right eye in both groups were measured six months after the procedures using non touch method by anterior segment OCT without instillation of topical anaesthesia, at seven points in each eye (one central and 3 points at each sides of horizontal meridian).The three nasal points were located (1mm, 2mm, 3mm respectively) from the center and remaining three temporal points located again ( 1mm, 2mm, 3mm) from the center. Data from both groups were comparing to evaluate predictability and variability of the flap thickness.
Time Frame
6-months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Having refractive errors range from -2 to- 6 DS and from -1 to -3.00DC. They have stable refraction for at least one year prior to surgery. Normal topography by Placido-Scheimpflug (Sirius, Costruzione Strumenti Oftalmici, Florence, Italia) and normal corneal epithelial map by Anterior segment-OCT system (Optovue Inc, Fremont, California, USA) Exclusion Criteria: Patient with suspicious topography and or corneal epithelial map. Patient with corneal pachymetry below 500µm. Patients who have a history of previous ocular surgery or trauma. Patient with a current or previous history of herpes simplex or herpes zoster. Patient with severe dry eye, diabetes, thyrotoxicosis, and connective tissue diseases. Patient with Combined ocular diseases like retinal dystrophy or glaucoma. Patient with a history of contact lenses use was meant to stop the use of soft contact lenses for at least 2 weeks or hard type for at least 4 weeks before topography and other investigations were done. Patient who refrains from the required follow-up visits; have been excluded from the study. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzan Rattan, lecturer
Organizational Affiliation
Al-Kindy College of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Eye Speciality private hospital
City
Baghdad
ZIP/Postal Code
1001
Country
Iraq

12. IPD Sharing Statement

Citations:
PubMed Identifier
36307607
Citation
Rattan SA, Rashid RF, Mutashar MK, Nasser YAR, Anwar DS. Comparison of corneal flap thickness predictability and architecture between femtosecond laser and sub-Bowman keratomileusis microkeratome in laser in situ keratomileusis. Int Ophthalmol. 2023 May;43(5):1553-1558. doi: 10.1007/s10792-022-02551-8. Epub 2022 Oct 29.
Results Reference
derived

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Femto-flap Versus SBK Flap,Predictability and Variability

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