A Prospective Study of Femtosecond Laser Intracorneal Lensectomi

Myopia Clinical Trial

Official title:

A Prospective Study of Femtosecond Laser Intracorneal Lensectomi in Treatment of Moderate to High Myopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673503
• Other study ID #: S-20100111
• Status: Completed
• Phase: Phase 3
• First received: August 20, 2012
• Last updated: January 23, 2013
• Start date: May 2011

Study information

• Verified date: January 2013
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: University of Southern DenmarkDenmark: Department of Ophthalmology at both Odense University Hospital and Aarhus University Hospital - Aarhus Sygehus.Denmark: The Regional Scientific Ethical Committee for Southern DenmarkDenmark: The Central Denmark Region Committees on Health Research EthicsDenmark: The Danish Data Protection Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare visual acuity, safety, predictability, corneal biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive lenticule extraction. Approximately 30 to 40 patients with moderate to high myopia will randomly (after ocular dominance) receive ReLEx flex in one eye, and ReLEx smile in the other.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• 25 to 45 years,

• moderate to high myopia with astigmatism =< 2 D,

• otherwise eye healthy,

• CDVA of 0.8 or better (Snellen).

Exclusion Criteria:

• systemic or ocular disease or previous eye surgery,

• thin cornea,

• a difference of more than 2 D myopia in the eyes of each subject.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Device:
• Carl Zeiss Meditech VisuMax laser
Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser

Locations

Country	Name	City	State
Denmark	Department of Ophthalmology Aarhus Sygehus - Aarhus University Hospital, Denmark	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Corneal biomechanics, corneal nerve changes and dry eye symptoms	Corneal hysteresis and corneal resistence factor using the Ocular response analyser, nerve changes using the Cochet-Bonnet Aesthesiometer and confokal mikroscopy, and dry eyes symptoms using Schirmers test, Tear BUT, and Oculus keratograph, along with anterior segment OCT to measure tear meniscus hight.	pre-surgery and 6 months after	Yes
Primary	Visual acuity	Using ETDRS charts, both uncorrected and corrected distance visual acuity, along with visual acuity using the FrACT contrast chart	up to 6 months	Yes
Secondary	refractive predictability	Optometrists measure refraction at follow-up-examinations, and the refraction 6 monhts after surgery will be compared to the target refraction to calculate refractive predictability	Pre-surgery, 1 week, 1 month, 3 months, 6 months	Yes