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.

Prospective, Non-randomized, Multicenter, Parallel group (55-75 subjects) Clinical Investigation of Extended Range of Vision (ERV) Intraocular Lenses, XRA03 and Toric series ZXT on Best-Corrected Distance Visual Acuity in Participants Requiring Bilateral Cataract Removal and Lens Replacement Sequentially In Both Eyes .

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001189718

Acronym

EROV-107-ZXRT

Enrollment

Registered

2013-10-29

Start date

2014-04-14

Completion date

2015-06-10

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study objective is to evaluate the clinical outcomes of far, intermediate and near visual acuity and the rates of complications and adverse events in subjects implanted with the ERV Model XRA03 IOL and the ERV Toric IOL, Model Series ZXT.

Interventions

Investigational Toric ERV Intraocular lens (IOL). This model series ZXT is a modification from the currently marketed Tecnis Toric IOL with the same toric options in a range of 1.50 D – 4.00 D. The spherical diffractive posterior surface of the Toric lens optic has been designed to provide an increased range of vision (far, intermediate and near) and a reduction in residual refractive cylinder. The eye will be marked preoperatively for a standard axis orientation for toric lens placement, the cataractous lens will be removed during a routine phacoemulsification procedure lasting approximately 30 mins, and the toric lens will be implanted using the preoperative marks as guidelines. Once implanted using an Abbott lens inserter/unfolder, the design benefits of the lens are intended to be permanent.

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

20 Years to 100 Years

Healthy volunteers

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

Outcome results