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

H

Hospital Hietzing

Status and phase

Completed
Phase 4

Conditions

Cataract

Treatments

Procedure: cataract surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT00673803
preloaded 2008

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

55 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

A
Other group
Description:
cataract surgery, implantation of a Polylens Y10
Treatment:
Procedure: cataract surgery
B
Other group
Description:
cataract surgery, implantation of a Polylens Y30
Treatment:
Procedure: cataract surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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