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Comparison Between FS- LASIK and FS-SMILE for Correction of Myopia and Myopic Astigmatism

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ClinicalTrials.gov Identifier: NCT02962544
Recruitment Status : Unknown
Verified November 2016 by Esraa Mohamed Adel Mohamed El-mayah, Kasr El Aini Hospital.
Recruitment status was:  Recruiting
First Posted : November 11, 2016
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
Esraa Mohamed Adel Mohamed El-mayah, Kasr El Aini Hospital

Brief Summary:
Aim of the work is to compare the results of femtosecond assisted LASIK and small incision lenticule extraction (SMILE) as regards safety, efficacy and predictability. As a secondary outcomes , the investigators will compare the results of both techniques on corneal biomechanics, dry eye measures, corneal asphericity and higher order aberration.

Condition or disease Intervention/treatment Phase
Myopia Procedure: FS-SMILE Procedure: FS- LASIK Device: Visumax device Device: FS 200 device Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Femtosecond Assisted LASIK and Small Incision Lenticule Extraction (SMILE) for Correction of Myopia and Myopic Astigmatism
Study Start Date : March 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Visumax device for FS-SMILE group
(FS-SMILE )femtosecond small incision lenticule extraction procedure using Visumax laser device as a surgical intervention for correction of myopia and myopic astigmatism will be done for 30 eyes of patients with myopia or myopic astigmatism.
Procedure: FS-SMILE
The procedure will be performed using an established technique. the patient's eye will be centered and docked with the curved interface cone before application of suction fixation.The laser will be activated for photo-dissection in the following sequence: first the posterior surface of the refractive lenticule then the lenticule border then The anterior surface of the refractive lenticule which extended beyond the posterior lenticule diameter by 0.5 mm to form the anterior flap and is followed by a rim cut. After the suction is released, a Siebel spatula is inserted under the cap near the hinge before the cap is separated. The edge of the refractive lenticule is separated from the stromal bed with a sinsky hook and the posterior border of the lenticule gently separated with the Siebel spatula. The lenticule is then grasped with forceps through the small incision.

Device: Visumax device
Active Comparator: FS 200 device for FS-LASIK group
(FS-LASIK)femtosecond assisted LASIK procedure using Fs200 laser device as a surgical intervention for correction of myopia and myopic astigmatism will be done for 30 eyes of patients with myopia or myopic astigmatism.
Procedure: FS- LASIK
LASIK procedure Each LASIK procedure will be performed using a standard, established technique. Under topical anesthesia and standard draping, a lid speculum is used to retract the eyelids. A superiorly hinged 100 μm thick flap will be created using the WaveLight FS200 (Alcon Laboratories, Inc.) With inverted side cut (115 ̊) .Excimer laser ablation is then performed using WaveLight EX500 excimer laser (Alcon Laboratories, Inc.).After ablation, the flap will be carefully repositioned, and postoperative medications are commenced.

Device: FS 200 device



Primary Outcome Measures :
  1. refractive predictability(manifest refraction spherical equivalent using autorefractometer) [ Time Frame: change from baseline at 3 months postoperative. ]
    • Refractive predictability, which is defined as the proportion number of eyes achieving a postoperative spherical equivalent (SE) within ±0.50 D of the intended target.

  2. efficacy(Unaided distance visual acuity using snellen chart) [ Time Frame: change from baseline at 3 months postoperative. ]
    Efficacy: defined as the proportion number of eyes achieving an unaided visual acuity (UDVA) of 20/20 or better postoperatively (efficacy= postoperative UCVA/preoperative BCVA %).

  3. safety( Corrected distance visual acuity using snellen chart) [ Time Frame: change from baseline at 3 months postoperative. ]
    Safety: defined as the proportion number of eyes that lost or gained one or more lines of postoperative best corrected visual acuity (BCVA) relative to the preoperative BCVA (Safety= Postoperative BCVA/preoperative BCVA %)


Secondary Outcome Measures :
  1. corneal hysteresis [ Time Frame: change from baseline at 3 months postoperative. ]
    corneal hysteresis will be measured by ORA device and the investigators will compare between the preoperative and postoperative results in both groups.

  2. schirmer test [ Time Frame: change from baseline at 3 months postoperative. ]
    schirmer test and tear breack up time test will be tested pre and postoperatively and the investigators will compare between the preoperative and postoperative results in both groups.

  3. corneal higher order aberrations.( total RMS) [ Time Frame: change from baseline at 3 months postoperative. ]
    corneal higher order aberrations( total RMS) will be measured and comparison between the preoperative and postoperative value will be conducted.

  4. corneal resistance factor [ Time Frame: change from baseline at 3 months postoperative. ]
    corneal resistance factor will be measured by ORA device and the investigators will compare between the preoperative and postoperative results in both groups.

  5. tear break up time test. [ Time Frame: change from baseline at 3 months postoperative. ]
    tear breack up time test will be tested pre and postoperatively and the investigators will compare between the preoperative and postoperative results in both groups.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age is 18 years or older.
  2. Best corrected visual acuity of 6/6.
  3. Manifest refraction spherical equivalent (MRSE) not more than 9diopters (D).
  4. Refractive cylinder not more than 3 diopters (D).
  5. No topographic evidence of forme frust keratoconus (FFKC).
  6. No progressive change of sphere or cylinder more than 0.5 diopter per year.

Exclusion Criteria:

  1. Previous history of ocular trauma or ocular surgery.
  2. Concomitant active or previous ocular disease such as uveitis and glaucoma.
  3. Systemic diseases affecting wound healing such as diabetes mellitus, collagen vascular diseases
  4. Dry eye.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962544


Contacts
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Contact: Esraa MA El-Mayah, Msc (002)01002208106 e_mayah87@yahoo.com
Contact: esraa MA El-Mayah, MSC (002)010002208106 E_MAYAH87@YAHOO.COM

Locations
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Egypt
Kasr Alainy Hospital Recruiting
Cairo, Egypt, 11956
Contact: Esraa MA EL-Mayah, MSC    (002)01002208106    E_MAYAH87@YAHOO.COM   
Principal Investigator: Mohsen N Salem, MD         
Principal Investigator: Mohamed H Hosny, MD         
Principal Investigator: Mohamed Anis, MD         
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Study Director: Mohsen N Salem, MD Kasr alainy school of medicine
Study Director: mohamed H hosny, MD Kasr alainy school of medicine
Study Director: MOHAMED ANIS, MD Kasr alainy school of medicine

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Responsible Party: Esraa Mohamed Adel Mohamed El-mayah, Assistant lecturer, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT02962544     History of Changes
Other Study ID Numbers: 151
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Esraa Mohamed Adel Mohamed El-mayah, Kasr El Aini Hospital:
Femtosecond
Small incision lenticule extraction
Lenticule extraction
LASIK
Myopia

Additional relevant MeSH terms:
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Myopia
Astigmatism
Refractive Errors
Eye Diseases