Clinical Study of New Intraocular Lens Design in Participants requiring Bilaterial Cataract Removal

A Prospective, Non-randomised, Technician-masked, Parallel group (40-50 subjects), Dual site, Clinical Investigation of a new Intraocular Lens (model XRA03) when compared to the Control, Tecnis 1-piece Monofocal Lens (ZCB00) in participants requiring Bilaterial Cataract Removal to Assess Binocular Distance Vision Acuity and Incidence of Dysphotopsias.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000262707

Enrollment

Registered

2013-03-05

Start date

2013-05-13

Completion date

2013-07-30

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 purpose of this clinical trial is to evaluate the binocular clinical performance of a design modification to the Tecnis Monofocal IOL, Model XRA03. Results will include descriptive statistics on the visual performance of Model XRA03 in bilaterally implanted subjects (post phacoemulsification of cataracts) over distance, intermediate and near vision. This study is a prospective, non-randomized, technician-masked, parallel-group study of 40-50 subjects across up to two investigative sites. Clinical Hypothesis: The study IOL, Model XRA03 will achieve a mean binocular distance visual acuity of 20/40 or better at each defocus point through -1.5 diopters with minimal levels of clinically significant dysphotopsias (night glare/halos) and potentially provide improved uncorrected intermediate to near vision compared to currently marketed monofocal acrylic lenses.

Interventions

In Model XRA03, the spherical diffractive posterior surface of the lens optic has been modified to provide an increased range of vision and partially corrects for chromatic aberrations. After phacoemulsification/removal of a cataractous lens, the study device is implanted using a manual "Platinum 1" screw style Unfolder/handpiece through a minimally invasive (~2.4mm) corneal incision. A standard operative time is 30-40min. Once implanted, the design benefits 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 No maximum

Healthy volunteers

Inclusion criteria

Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes Visual potential of Decimal 0.8 (Snellen 20/25) or better in each eye after cataract removal and IOL implantation Signed informed consent

Exclusion criteria

Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated) Acute or chronic disease or illness that would increase the operative risk or confound the outcome(s) of the study (e.g., uncontrolled, insulin-dependent diabetes, immunocompromised (including current or anticipated use of immunosuppressants), connective tissue disease, etc.) Surgery that is not resolved/stable or may affect vision Prior refractive surgery (LASIK, LASEK, RK, PRK, etc.) Corneal abnormalities such as stromal, epithelial or endothelial dystrophies Intraocular inflammation or recurrent ocular inflammatory condition Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.) Capsule or zonule abnormalities that may affect postoperative IOL centration or tilt, including pseudoexfoliation, trauma, or surgical complications (e.g. zonular rupture, eccentric anterior capsulorhexis) Requiring an intraocular study lens power outside the available range of +16.0 to +28.0 D

Outcome results