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

NCT02962544 | Unknown DMC

• 1 other identifier: 151
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

Femtosecond; Small incision lenticule extraction; Lenticule extraction; LASIK; Myopia

Outcome Measures

Primary Outcomes (3)

• refractive predictability(manifest refraction spherical equivalent using autorefractometer)

  • 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.

  change from baseline at 3 months postoperative.

• efficacy(Unaided distance visual acuity using snellen chart)

  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 %).

  change from baseline at 3 months postoperative.

• safety( Corrected distance visual acuity using snellen chart)

  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 %)

  change from baseline at 3 months postoperative.

Secondary Outcomes (5)

• corneal hysteresis

  change from baseline at 3 months postoperative.

• schirmer test

  change from baseline at 3 months postoperative.

• corneal higher order aberrations.( total RMS)

  change from baseline at 3 months postoperative.

• corneal resistance factor

  change from baseline at 3 months postoperative.

• tear break up time test.

  change from baseline at 3 months postoperative.

Study Arms (2)

Visumax device for FS-SMILE group

ACTIVE COMPARATOR

(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; Device: Visumax device

FS 200 device for FS-LASIK group

ACTIVE COMPARATOR

(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; Device: FS 200 device

Interventions

FS-SMILE PROCEDURE

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.

Visumax device for FS-SMILE group

FS- LASIK PROCEDURE

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.

FS 200 device for FS-LASIK group

Visumax device DEVICE

Visumax device for FS-SMILE group

FS 200 device DEVICE

FS 200 device for FS-LASIK group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alainy Hospital

Cairo, 11956, Egypt

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• 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

  STUDY DIRECTOR

Central Study Contacts

Esraa MA El-Mayah, Msc

CONTACT

(002)01002208106; e_mayah87@yahoo.com

esraa MA El-Mayah, MSC

CONTACT

(002)010002208106; E_MAYAH87@YAHOO.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: November 11, 2016
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: November 11, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)