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Femto-flap Versus SBK Flap,Predictability and Variability

NCT04684888 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-07-20

No results posted yet for this study

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.

Conditions

  • Refractive Errors
  • Refractive Surgery

Interventions

PROCEDURE

Visumax Femto-flap

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.

PROCEDURE

Sub Bowman's keratomileusis (SBK)-flap

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 .

Sponsors & Collaborators

  • Suzan A Rattan

    lead OTHER

Principal Investigators

  • Suzan Rattan, lecturer · Al-Kindy College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
38 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-09-30
Completion
2021-05-30

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04684888 on ClinicalTrials.gov