VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High Myopia

NCT02528123 | Completed Results DMC

• 1 other identifier: LoVC-004
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to validate the safety and effectiveness of treating myopia (short-sightedness) higher than -10D using small incision lenticule extraction (SMILE) with the VisuMax femtosecond laser.

Conditions

Myopia; Refractive Errors

Keywords

Small incision lenticule extraction (SMILE); Femtosecond laser

Outcome Measures

Primary Outcomes (1)

• Variability of the Refractive Predicatibility

  Calculate the standard deviation of the postoperative spherical equivalent, adjusted relative to the intended target, after the SMILE procedure. Analysis performed on the data from the 1 year postoperative visit. An accurate outcome is where the postoperative spherical equivalent is equal to the intended target spherical equivalent. A mean difference less than zero implies the outcome was undercorrected, whereas a mean difference greater than zero implies the outcomes was overcorrected. A smaller standard deviation represents a more accurate and more predictable outcome.

  1 year postop

Secondary Outcomes (7)

• Efficacy of Uncorrected Distance Visual Acuity

  1 year postop

• Safety of Corrected Distance Visual Acuity (Change in Corrected Distance Visual Acuity)

  1 year postop

• Predictability of Refractive Correction

  1 year postop

• Predictability of Refractive Astigmatism Correction

  1 year postop

• Stability of the Spherical Equivalent Refraction

  3 months and 1 year postop

Study Arms (1)

Small incision lenticule extraction

EXPERIMENTAL

Patients with high myopia will undergo a SMILE procedure to correct their refraction. Proxymetacaine 0.5% and Oxybuprocaine 0.4% will be used as anaesthetic during the procedure. Tobramycin and dexamethasone, and ofloxacin will be used four times a day for one week after the procedure.

Procedure: Small incision lenticule extraction; Drug: Tobramycin and dexamethasone; Drug: Ofloxacin; Drug: Proxymetacaine 0.5%; Drug: Oxybuprocaine 0.4%

Interventions

Small incision lenticule extraction PROCEDURE

The VisuMax femtosecond laser is used to create two interfaces that define a refractive lenticule of stromal tissue and a 2mm wide tunnel to connect the upper layer to the corneal surface. The lenticule is manually dissected and removed through the small 2mm incision without the need to create a flap as in LASIK.

Also known as: ReLEx smile, SMILE

Small incision lenticule extraction

Tobramycin and dexamethasone DRUG

Tobramycin and dexamethasone (Tobradex) eye drops will be used four times a day for 1 week after the procedure

Small incision lenticule extraction

Ofloxacin DRUG

Ofloxacin (Exocin) eye drops will be used four times a day for 1 week after the procedure

Small incision lenticule extraction

Proxymetacaine 0.5% DRUG

Proxymetacaine 0.5% eye drops will be used as an anaesthetic during the procedure

Small incision lenticule extraction

Oxybuprocaine 0.4% DRUG

Oxybuprocaine 0.4% eye drops will be used as an anaesthetic during the procedure

Small incision lenticule extraction

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only patients who are medically suitable for corneal refractive surgery can be included in the study.
• Subjects should be 21 years of age or older
• Eyes with high myopia spherical equivalent between -9.00 D up to -14.00 D, with cylinder up to 7.00 D
• The corrected distance visual acuity will be 20/40 or better in each eye pre-operatively
• Calculated sub-lenticule thickness (SLT) ≥220 µm
• Calculated total uncut stromal thickness (TUST) ≥300 µm
• Contact lens wearers must stop wearing their contact lenses at least four weeks per decade of wear before baseline measurements in case of hard contact lenses and one week before baseline measurements in case of soft contact lenses.
• Patient will be able to understand the patient information and willing to sign an informed consent
• Patient will be willing to comply with all follow-up visits and the respective examinations as specified in the flow-chart

You may not qualify if:

• Previous intraocular or corneal surgery of any kind on the eye being treated
• Patient not being able to lie flat in a horizontal position
• Patient not being able to tolerate local or topical anesthesia
• Autoimmune diseases
• Sicca syndrome, dry eye
• Herpes viral (herpes simplex) infections
• Herpes zoster
• Diabetes
• Pregnant or nursing women (or who are planning pregnancy during the study)
• Patients with a weight of \> 135 kg
• Any residual, recurrent or acute ocular disease or abnormality of the eye, e.g.
• Cataract
• Suspected glaucoma or an intraocular pressure \> 21 mm of Hg
• Corneal disease
• Corneal thinning disorder, e.g. keratoconus,

Sponsors & Collaborators

• London Vision Clinic: lead

Study Sites (1)

London Vision Clinic

London, W1G 7LA, United Kingdom

Location

Related Publications (7)

• Hjortdal JO, Vestergaard AH, Ivarsen A, Ragunathan S, Asp S. Predictors for the outcome of small-incision lenticule extraction for Myopia. J Refract Surg. 2012 Dec;28(12):865-71. doi: 10.3928/1081597X-20121115-01.

  PMID: 23231737 BACKGROUND

• Reinstein DZ, Carp GI, Archer TJ, Gobbe M. Outcomes of small incision lenticule extraction (SMILE) in low myopia. J Refract Surg. 2014 Dec;30(12):812-8. doi: 10.3928/1081597X-20141113-07.

  PMID: 25437479 BACKGROUND

• Kamiya K, Shimizu K, Igarashi A, Kobashi H. Visual and refractive outcomes of femtosecond lenticule extraction and small-incision lenticule extraction for myopia. Am J Ophthalmol. 2014 Jan;157(1):128-134.e2. doi: 10.1016/j.ajo.2013.08.011. Epub 2013 Oct 7.

  PMID: 24112634 BACKGROUND

• Moshirfar M, McCaughey MV, Reinstein DZ, Shah R, Santiago-Caban L, Fenzl CR. Small-incision lenticule extraction. J Cataract Refract Surg. 2015 Mar;41(3):652-65. doi: 10.1016/j.jcrs.2015.02.006.

  PMID: 25804585 BACKGROUND

• Shah R, Shah S, Sengupta S. Results of small incision lenticule extraction: All-in-one femtosecond laser refractive surgery. J Cataract Refract Surg. 2011 Jan;37(1):127-37. doi: 10.1016/j.jcrs.2010.07.033.

  PMID: 21183108 BACKGROUND

• Ganesh S, Gupta R. Comparison of visual and refractive outcomes following femtosecond laser- assisted lasik with smile in patients with myopia or myopic astigmatism. J Refract Surg. 2014 Sep;30(9):590-6. doi: 10.3928/1081597X-20140814-02.

  PMID: 25250415 BACKGROUND

• Sekundo W, Kunert KS, Blum M. Small incision corneal refractive surgery using the small incision lenticule extraction (SMILE) procedure for the correction of myopia and myopic astigmatism: results of a 6 month prospective study. Br J Ophthalmol. 2011 Mar;95(3):335-9. doi: 10.1136/bjo.2009.174284. Epub 2010 Jul 3.

  PMID: 20601657 RESULT

MeSH Terms

Conditions

Myopia; Refractive Errors

Interventions

Tobramycin; Dexamethasone; Ofloxacin

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Prof Dan Z Reinstein
• Organization: London Vision Clinic

dzr@londonvisionclinic.com

02072214005

Study Officials

• Dan Z Reinstein, MD MA

  London Vision Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 19, 2015
• Study Start: April 1, 2016
• Primary Completion: December 7, 2020
• Study Completion: December 7, 2020
• Last Updated: April 23, 2024
• Results First Posted: April 23, 2024

Record last verified: 2024-04

Locations

GB (1)