CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 61 enrolled
Drug / intervention
Supracorprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01322919
NCT01322919Phase 3Completed

A Prospective Study to Evaluate the Safety and Effectiveness of the Presbyopic LASIK Algorithm

Technolas Perfect Vision GmbH·interventional·Posted Mar 25, 2011·Updated May 20, 2015

In Brief

A Phase 3 clinical trial evaluating Supracor for Myopia and 3 related conditions. Completed, enrolled 61 participants across 1 site.

Detailed Summary

By using a new software two consecutive laser treatments have been combined to correct the distance vision and to provide a near vision component in addition to the first treatment. This study will help us to answer 2 questions: 1. How accurately this combined technique corrects distance and near vision 2. Whether the correction is adequate to remove the complete need for supplementary near spectacles

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 25, 2011
Enrollment StartApr 1, 2010
Primary CompletionFeb 1, 2012
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.3 years ago

Interventions

Supracorprocedure

All patients will undergo LASIK treatment on their non-dominant eye with a new laser software algorithm designed to treat both the distance and near vision components. The developed software algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction. This part of the treatment does not show any difference to a regular LASIK treatment for ametropic cases. In addition to the treatment for the distance vision a central ablation component will be added to address the near vision.