Light Filters in Intraocular Lenses (IOLs) and Its Influence on Colour and Contrast Vision.

Cataract Clinical Trial

Official title:

Influence of Light-filters in IOLs on Color Perception and Contrast Acuity. A Randomized, Double-masked Study With Intraindividual Comparison.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612729
• Other study ID #: Ye-Or 2008
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2008
• Last updated: August 16, 2010
• Start date: May 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

Visible-light-filtering IOLs are implanted increasingly often in cataract surgery. Several studies examined the effect of light-filters on contrast and colour vision. However, the study outcomes were varying. The present study investigated the effect of two light-filtering IOL on colour perception and contrast acuity using highly sensitive measurement methods.

Description:

Prospective, randomized, double-masked study with intraindividual comparison. Implantation of a Polylens Y30 IOL in one eye and an Orange Series Model PC 440 Y in the contralateral eye.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2010
• Est. primary completion date: November 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 1.0

Exclusion Criteria:

• amblyopia

• corneal scars

• diabetes

• arterial hypertonia

• pseudoexfoliation-syndrome

• earlier ocular surgeries or laser treatments

• intraocular tumors

• color abnormalities

• expected postoperative visual acuity lower 1.0

Study Design

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

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Polylens Y30 intraocular lens
cataract surgery
• Orange Series Model PC 440 Y intraocular lens
cataract surgery

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	contrast acuity		3 month after surgery	No
Secondary	visual acuity and color vision		3 month after surgery	No
Secondary	colour perception		3 month after surgery	No