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Influence of Two Different Preloaded Intraocular Lens (IOLs) on Posterior Capsule Opacification

Influence of Two Sharp-edged Hydrophobic Acrylic Micro-incision-IOLs on Posterior Capsule Opacification. A Randomized, Double-masked Study With Intraindividual Comparison.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00673803
Enrollment
40
Registered
2008-05-07
Start date
2008-12-31
Completion date
2010-06-30
Last updated
2010-08-17

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

Conditions

Cataract

Keywords

posterior capsule opacification, micro incision, sharp optic edge

Brief summary

Studies showed that a sharp posterior optic edge of an intraocular lens (IOL) inhibits migration of lens epithelial cells in between posterior capsule and optic of the IOL and therefore reduces the rate of posterior capsule opacification (PCO). In present time most IOLs implanted have a sharp posterior optic edge. Due to differences in IOL production different IOLs have different rates of PCO. Progression in cataract surgery technique allow phacoemulsification through micro-incisions. Therefore there is need for IOLs that can be implanted through incisions of about 2.5 mm. This study investigates the effect of two different hydrophobic acrylic IOLs with a sharp posterior optic edge on the rate of PCO after implantation through a micro-incision. The results will be compared intraindividually.

Detailed description

prospective, randomized, bilateral study with intraindividual comparison, implantation of a Polylens Y10 IOL in one eye and implantation of a Polylens Y30 in the contralateral eye. PCO rate will be detected at 1 year and 2 years.

Interventions

PROCEDUREcataract surgery

cataract surgery with implantation of an IOL

Sponsors

Hospital Hietzing
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* bilateral age-related cataract * age 55 to 80 years * expected postoperative visual acuity of at least 0.5

Exclusion criteria

* amblyopia * corneal scars * diabetes * pseudoexfoliation-syndrome * earlier ocular surgeries or laser treatments * intraocular tumors

Design outcomes

Primary

MeasureTime frame
PCO rate2 years after surgery

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026