Proof of Concept Study of a Diffractive Trifocal Phakic Implantable Collamer Lens (ICL) in Presbyopes
| Registry | NCT07790965 |
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| Status | Not yet recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, treatment |
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| Enrollment | 10 (Estimated) |
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| Sponsor | Staar Surgical Company (Industry) |
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| Conditions | Myopia, Astigmatism |
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| Interventions | Phakic Implantable Collamer Lens (ICL) (Device) |
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| Dates | start 2026-11-01 (estimated), primary completion 2027-05-01 (estimated), completion 2027-05-01 (estimated), first posted 2026-08-27, last updated 2026-08-27 |
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Related Papers Related Patents Related Grants Related Experts
All trials for Myopia All trials for Astigmatism All trials of Phakic Implantable Collamer Lens (ICL)
-Summary
A prospective, open-labeled, single-site study of a phakic implantable collamer lens (ICL) for the correction/reduction of myopia with or without astigmatism.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Participants bilaterally implanted with a phakic implantable collamer lens (ICL) | Experimental | Device: Phakic Implantable Collamer Lens (ICL) | Participants will receive a phakic implantable collamer lens (ICL) in each eye |
- Phakic Implantable Collamer Lens (ICL) (Device): Diffractive Trifocal Phakic ICL
+Outcome measures
Primary outcomes
- Cumulative and Persistent Adverse Events [3 Months]: Safety Population
Other outcomes
- Rates of Secondary Surgical Interventions [3 Months]: Safety Population
- Frequency and Proportion of Eyes With Visual Symptoms [3 Months]: Safety Population - Visual Symptoms will be captured using a patient reported outcome questionnaire
- Frequency and Proportion of Eyes With Ocular and Visual Symptoms [3 Months]: Safety Population - Visual Symptoms will be captured using a patient reported outcome questionnaire
- Uncorrected Distance Visual Acuity [3 Months]: Safety Population - Mean Change and Mean Difference
- Uncorrected Intermediate Visual Acuity [3 Months]: Safety Population - Mean Change and Mean Difference
- Uncorrected Near Visual Acuity [3 Months]: Safety Population - Mean Change and Mean Difference
- Best Corrected Distance Visual Acuity [3 Months]: Safety Population - Mean Change and Mean Difference
- Distance Corrected Intermediate Visual Acuity [3 Months]: Safety Population - Mean Change and Mean Difference
- Distance Corrected Near Visual Acuity [3 Months]: Safety Population - Mean Change and Mean Difference
- Mean Monocular Contrast Sensitivity [3 Months]: Safety Population
- Defocus Curves from +1.0 D through -3.0 D Defocus [3 Months]: Safety Population
- Subjective Visual Quality [3 Months]: Safety Population - Visual Symptoms will be captured using a patient reported outcome questionnaire
+Eligibility
Sex: All, ages: 21 Years to 60 Years
Inclusion Criteria:
* Must be between the age of 21 - 60 years
* Must be suitable for ICL surgery,
* Must meet all unique study eligibility criteria
Exclusion Criteria:
* Outside the age of 21 - 60 years,
* Not a suitable candidate for ICL surgery,
* Does not meet all unique study eligibility criteria
+Investigators