Clinical Investigation of the Extended Range of Vision (ERV) Intraocular Lenses (IOLs), Model XRA03 and Toric Series ZXT in Participants Requiring Bilateral Cataract Removal and Lens Replacement.

Phase 2

Active, not recruiting

• Conditions: Bilateral Cataract removal and replacment of crystalline lens with an investigational extended range of vision IOL, in otherwise healthy eyes; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12613001189718
• Lead Sponsor: Abbott Medical Optics Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Bilateral cataracts for which phacoemulsification extraction and posterior chamber IOL implantation are planned
2. Visual potential of 6/7.5 Metric (20/25 Snellen) or better in each eye following cataract removal and IOL implantation
3. Clear intraocular media other than cataract in each eye
4. Normal corneal topography

5. Subjects for ERV Model Series ZXT only:
5.1 Preoperative corneal cylinder between 0.75 D and 3.62 D in both eyes and an AMO Toric calculation lens model recommendation of a ZCT lens equal to the study lens powers of ZXT150, ZXT225, ZXT300, or ZXT375, with a predicted spherical equivalent outcome of emmetropia (+/-0.25 D).

Exclusion Criteria

1. Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
2. Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
3. Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery
4.Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses
5. Use of systemic or ocular medications that may affect vision
6. No irregular corneal astigmatism.
7. Poorly-controlled diabetes
8. Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects

Study & Design

• Study Type: Interventional
• Study Design: Not specified