Study of an Implantable Collamer Lens (ICL)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorStaar Surgical Company
About this trial
A prospective, open-labeled, single-site study of an implantable collamer lens (ICL) for the correction/reduction of myopia with or without astigmatism.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be between the age of 21 - 60 years,
Must be suitable for ICL surgery,
Must meet all unique study eligibility criteria
Disqualifiers
Outside the age of 21 - 60 years,
Not a suitable candidate for ICL surgery,
Does not meet all unique study eligibility criteria
Trial design
Design model
Single group
Treatments tested in this trial
Implantable collamer lens (ICL)
DeviceICL with aspheric optic
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Participants bilaterally implanted with an implantable collamer lens (ICL)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative and Persistent Adverse Events
Safety Population
Time frame
3 MonthsOther outcomes
1
Rates of Secondary Surgical Interventions
Safety Population
Time frame
3 Months2
Frequency and Proportion of eyes with visual symptoms
Safety Population - Visual Symptoms will be captured using a patient reported outcome questionnaire
Time frame
3 Months3
The frequency and proportion of eyes with ocular and visual symptoms
Safety Population - Visual Symptoms will be captured using a patient reported outcome questionnaire
Time frame
3 Months4
Uncorrected Distance Visual Acuity
Safety Population - Mean Change and Mean Difference
Time frame
3 MonthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: