NCT01675492

Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism

Completed NA Results posted Last updated 4 February 2025

What this trial tests

NA trial testing LASIK in Astigmatism in 126 participants. Completed in 22 November 2016.

Timeline

6 December 2012

Primary endpoint
22 November 2016

22 November 2016

Quick facts

Lead sponsor	Abbott Medical Optics
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	126
Start date	6 December 2012
Primary completion	22 November 2016
Estimated completion	22 November 2016

Drugs / interventions tested

• LASIK

Conditions studied

• Astigmatism — all drugs for Astigmatism →

Sponsor

Abbott Medical Optics

Who can join

18 and older, any sex, with Astigmatism. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA) Primary · 3 Months

\< 5% of eyes will have a loss of \> 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters

Group	Value	95% CI
Wave-front Guided LASIK	149

Uncorrected Visual Acuity (UCVA) of 20/40 or Better Secondary · 3 Months

85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters

Group	Value	95% CI
Wave-front Guided LASIK	149

Sponsor's own description

To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.