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VERION vs conventional, manual ink-marking in toric IOL implantation

VERION vs conventional, manual ink-marking in toric IOL implantation - VERION study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42224
Enrollment
36
Registered
2015-04-08
Start date
2015-05-18
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

cataract

Interventions

Cataract surgery with the implantation of a toric IOL using either conventional ink-marking method, or the VERIONTM-tools for the alignment of the IOL.

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Astigmatism (at least 1.25D) - Cataract - Are at least 18 years of age - Eye eligible to undergo cataract extraction - Eye eligible for toric IOL implantation - Bilateral eyes: availability to undergo second eye surgery within 2 weeks of the first eye surgery - Willing and able to comply with scheduled visits and other study procedures - Understand and signed informed consent

Exclusion criteria

Exclusion criteria: - Irregular corneal astigmatism or keratoconus - Extensive age related macular degeneration (atrophic or exudative AMD or numerous soft drusen) - Fuchs endothelial dystrophy (stage 2) - Uncontrolled/manifest glaucoma - Glaucoma related extensive visual field loss - Extensive diabetic macular disease - Previous intraocular or corneal surgery of any kind - Subjects presenting any contraindications to cataract surgery - Subjects with a recurrent or active ocular or uncontrolled eyelid disease - Subjects with a history of lens instability (e.g. posterior polar cataract, traumatic cataract) or zonular instability - Subjects with concentration disorders, epilepsy or other complicating diseases (e.g. CVA) - Complications during surgery.

Design outcomes

Primary

MeasureTime frame
Average error (in degrees) in toric IOL-axis postoperative at month 3.

Secondary

MeasureTime frame
- Percentage of eyes with residual refractive cylinder

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)