N/A
Completed N=125
STAAR Visian Toric ICL Post-Approval Study
Source: ClinicalTrials.gov NCT04516772 ↗Enrolled (actual)
125
Serious AEs
8.7%
Results posted
Mar 2026
Primary outcomePrimary: Change in Axis Orientation of the TICL — 104; 4 Eyes
Summary
The objective of this study is to evaluate the long term (i.e. 24 months) clinical performance of the Visian® Toric Implantable Collamer® Lens (ICL).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Axis Orientation of the TICL |
104; 4 | — |
| SECONDARY Absolute Rotation of the TICL Between Visits (Change From Operative Visit to Day 1) |
1.30 | — |
| SECONDARY Absolute Rotation of the TICL Between Visits (Change From Day 1 to Week 1) |
1.0 | — |
| SECONDARY Absolute Rotation of the TICL Between Visits (Change From Week 1 to Month 1) |
1.0 | — |
| SECONDARY Absolute Rotation of the TICL Between Visits (Change From Month 1 to Month 3) |
0.50 | — |
| SECONDARY Absolute Rotation of the TICL Between Visits (Change From Month 3 to Month 6) |
0.50 | — |
| SECONDARY Absolute Rotation of the TICL Between Visits (Change From Month 6 to Month 12) |
0.40 | — |
| SECONDARY Absolute Rotation of the TICL Between Visits (Change From Month 12 to Month 18) |
0.30 | — |
| SECONDARY Absolute Rotation of the TICL Between Visits (Change From Month 18 to Month 24) |
0.20 | — |
| SECONDARY Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Operative Visit) |
230; 230; 230; 231; 1; 0 | — |
| SECONDARY Absolute Rotation of the TICL <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Day 1) |
205; 206; 209; 210; 0; 20 | — |
| SECONDARY Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Week 1 Visit) |
207; 211; 211; 212; 1; 15 | — |
| SECONDARY Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 1 Visit) |
210; 213; 214; 215; 3; 9 | — |
| SECONDARY Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 3 Visit) |
206; 211; 212; 213; 2; 8 | — |
| SECONDARY Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 6 Visit) |
199; 205; 207; 208; 3; 6 | — |
| SECONDARY Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 12 Visit) |
200; 205; 206; 207; 3; 10 | — |
| SECONDARY Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 18 Visit) |
193; 198; 200; 201; 3; 8 | — |
| SECONDARY Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 24 Visit) |
192; 197; 198; 199; 1; 8 | — |
| SECONDARY Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Operative Visit) |
0.30 | — |
| SECONDARY Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Day 1 Visit) |
1.40 | — |
| SECONDARY Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Week 1 Visit) |
1.60 | — |
| SECONDARY Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 1 Visit) |
2.20 | — |
| SECONDARY Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 3 Visit) |
1.80 | — |
| SECONDARY Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 6 Visit) |
2.30 | — |
| SECONDARY Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month12 Visit) |
2.30 | — |
| SECONDARY Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 18 Visit) |
2.40 | — |
| SECONDARY Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 24 Visit) |
1.80 | — |
| SECONDARY Manifest Refraction Spherical Equivalent (MRSE) at Month 1 |
-0.20 | — |
| SECONDARY Manifest Refraction Spherical Equivalent (MRSE) at Month 3 |
-0.19 | — |
| SECONDARY Manifest Refraction Spherical Equivalent (MRSE) at Month 6 |
-0.21 | — |
| SECONDARY Manifest Refraction Spherical Equivalent (MRSE) at Month 12 |
-0.23 | — |
| SECONDARY Manifest Refraction Spherical Equivalent (MRSE) at Month 18 |
-0.21 | — |
| SECONDARY Manifest Refraction Spherical Equivalent (MRSE) at Month 24 |
-0.19 | — |
| SECONDARY Manifest Refraction Cylinder at Month 1 |
-0.54 | — |
| SECONDARY Manifest Refraction Cylinder at Month 3 |
-0.55 | — |
| SECONDARY Manifest Refraction Cylinder at Month 6 |
-0.50 | — |
| SECONDARY Manifest Refraction Cylinder at Month 12 |
-0.47 | — |
| SECONDARY Manifest Refraction Cylinder at Month 18 |
-0.43 | — |
| SECONDARY Manifest Refraction Cylinder at Month 24 |
-0.41 | — |
Eligibility Criteria
Inclusion Criteria
- Moderate to high myopia with astigmatism correctable with available TICL powers.
- Stable refractive history within 0.50 D each cylinder and spherical equivalent (SE) for 1 year prior to implantation.
- Able and willing to return for scheduled follow-up examinations after surgery.
- Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)-approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Insulin-dependent diabetes or diabetic retinopathy.
- History of previous ocular surgery.
- Cataract of any grade.
- Monocular.
- Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04516772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.