Clinical Trials Directory

Trials / Completed

CompletedNCT01252654

Comparison of Intralase and Visumax Femtosecond Laser for Laser In Situ Keratomileusis

Status
Completed
Phase
Study type
Observational
Enrollment
45 (actual)
Sponsor
Singapore Eye Research Institute · Academic / Other
Sex
All
Age
21 Years – 60 Years
Healthy volunteers
Not accepted

Summary

Emtosecond lasers are used in cutting the flap in LASIK procedures (laser corrective surgery for refractive error). Their use has decreased the incidence of serious complications when compared to the use of microkeratomes(mechanical blades). The commonest femtosecond laser currently used is 'Intralase'. A newer femtosecond laser 'Visumax' (Zeiss) is now available and differs from the Intralase in that it does not interfere with the curvature of the cornea when creating the flap. The Intralase applanates the cornea flat during flap creation which causes the intraocular pressure to be higher. Both Intralase and Visumax lasers are available to patients and surgeons to use at SNEC. The aim of the investigators study is to compare the two lasers in a randomization of left and right eyes in the same patient. The investigators want to measure any difference that the lower intraocular pressure may have during the creation of the flap. This will be measured with a questionaire on patient experience during the procedure and the outcomes of vision, refraction, contrast sensitivity, wave-front analysis, tear function,corneal sensation and flap thickness measured with anterior segment OCT during the post-operative follow up period. To date no-one has compared the use of these two femtosecond lasers. Both lasers are currently used clinically for flap creation at SNEC.

Conditions

Timeline

Start date
2010-01-01
Primary completion
2012-08-01
Completion
2013-08-01
First posted
2010-12-03
Last updated
2016-07-20

Locations

1 site across 1 country: Singapore

Source: ClinicalTrials.gov record NCT01252654. Inclusion in this directory is not an endorsement.