Evaluation of the Rotational Stability of the Tecnis Toric II IOL (NCT04327518) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Rotational Stability of the Tecnis Toric II IOL
United States125 participantsStarted 2020-06-11
Plain-language summary
This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Toric II IOL. The study will be conducted in up to 192 subjects needing unilateral or bilateral cataract surgery in up to 8 sites in United States (US). The subjects will be followed for up to 3-months postoperatively.
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. Minimum 22 years of age;
✓. Unilateral or Bilateral cataracts for which cataract extraction and posterior chamber IOL implantation have been planned;
✓. Pre-existing corneal astigmatism of one diopter or greater;
✓. Predicted residual refractive cylinder based on toric IOL calculator, considering surgically induced astigmatism (SIA) and posterior corneal astigmatism (PCA) must be ≤0.50 D;
✓. Potential for postoperative BCDVA of 20/30 Snellen or better;
✓. Clear intraocular media other than cataract in each eye;
✓. Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits;
✓. Signed informed consent form (ICF) and health insurance portability and accountability act (HIPAA) authorization;
Exclusion criteria
✕. Irregular corneal astigmatism;
✕. Any corneal pathology/abnormality other than regular corneal astigmatism or corneal instability due to contact lens wear;
✕. Previous corneal or intraocular surgery;
✕. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.);
What they're measuring
1
Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit
. Any pupil abnormalities (non-reactive, fixed, or abnormally shaped pupils);
✕. Dilated pupil size of \< 6.0 mm;
✕. Recurrent severe anterior or posterior segment inflammation or uveitis;
✕. Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects;