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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673803
• Other study ID #: preloaded 2008
• Status: Completed
• Phase: Phase 4
• First received: May 6, 2008
• Last updated: August 16, 2010
• Start date: December 2008
• Est. completion date: June 2010

Study information

• Verified date: December 2008
• Source: Hospital Hietzing
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract

Intervention

Procedure:
• cataract surgery
cataract surgery with implantation of an IOL

Locations

Country	Name	City	State
Austria	Department of Ophthalmology, Hietzing Hospital	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Hietzing

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCO rate		2 years after surgery	No