Blue-Blocking IOLs in Combined Surgery

Cataract Clinical Trial

Official title:

Blue Light-Filter IOLs in Vitrectomy Combined With Cataract Surgery: Results of a Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537992
• Other study ID #: FR-CI-03-2007
• Status: Completed
• Phase: N/A
• First received: October 1, 2007
• Last updated: October 1, 2007
• Start date: October 2004
• Est. completion date: March 2006

Study information

• Verified date: October 2007
• Source: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Although commonly used in cataract surgery, the use of the blue light-filter IOLs in vitrectomy combined with cataract surgery has not been reported yet. A prospective controlled clinical trial was designed to evaluate the effect of the blue light-filter IOL on the surgeon's ability to perform specific vitreoretinal procedures and on the patients' outcome.

Description:

Sixty patients were randomly assigned to receive a UV-filter IOL (transparent IOL group) or a blue light-filter IOL (yellow IOL group) combined with a vitreoretinal procedure.

Outcome measures were intraoperative conditions for the surgeon, complication rates, the functional outcome and vitreoretinal diagnoses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis vitreoretinal pathology (diabetic vitreous hemorrhage, macular hole, epiretinal membrane or persisting macula edema)

• Coexisting significant cataract

• The need for combined surgery ( pars plana vitrectomy, phacoemulsification and IOL implantation)

• Age over 50 years.

Exclusion Criteria:

• Pseudophakia on the non-study eye

• The need for silicone oil tamponade

• Optic atrophy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Epiretinal Membrane
• Epiretinal Membranes
• Macular Holes

Intervention

Procedure:
• combined surgery
UV-filter IOL (transparent IOL group) or a blue light-filter IOL (yellow IOL group) combined with a vitreoretinal procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

References & Publications (2)

Hayashi K, Hayashi H. Visual function in patients with yellow tinted intraocular lenses compared with vision in patients with non-tinted intraocular lenses. Br J Ophthalmol. 2006 Aug;90(8):1019-23. Epub 2006 Apr 5. — View Citation

Olson RJ, Werner L, Mamalis N, Cionni R. New intraocular lens technology. Am J Ophthalmol. 2005 Oct;140(4):709-16. Epub 2005 Jul 18. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative conditions for the surgeon (scaled questionnaire) and patients´ outcome
Secondary	complication rates and vitreoretinal diagnoses