NCT00571831

Brief Summary

To compare the effect on blood retinal barrier disruption 3 and 12 months after implantation of either a blue light filtering intraocular lens(blue-filtering IOL) or an ultraviolet light filtering intraocular lens(UV-filtering IOL).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2007

Completed
Last Updated

December 12, 2007

Status Verified

December 1, 2007

First QC Date

December 11, 2007

Last Update Submit

December 11, 2007

Conditions

to Compare the Effect of Two Types of IOLson the Incidence of Cystoid Macular EdemaAfter Cataract Surgery

Keywords

macula edemaintraocular lensprospective randomized parallel clinical design

Outcome Measures

Primary Outcomes (1)

  • To measure FA, VEP and OCT.

    At 3 and 12 months after IOL implantation

Study Arms (1)

letter

NO INTERVENTION

a blue-filtering IOL an UV-filtering IOL

Procedure: intraocular lens implantation

Interventions

intraocular lens implantationPROCEDURE

Intraocular lens implantation

Also known as: a blue-filtering IOL (ENV-13, Menicon Co.Ltd, Japan), an UV-filtering IOL (ES-13, Menicon Co.Ltd, Japan)
letter

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cataract patients
  • All eligible for intraocular lens implantation

You may not qualify if:

  • Patients had undergone an intraocular operation
  • Patients had hypertensive retinopathy
  • Patients had diabetic retinopathy
  • Patients had ange-related macular degeneration
  • no observable fundus
  • The cataract operation was more than 30 minutes in duration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Showa University Hospital

Tokyo, Tokyo, 142-8666, Japan

Location

MeSH Terms

Interventions

Lens Implantation, Intraocular

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ryohei Koide, MD, PhD

    Department of Ophthalmology, School of Medicine, Showa University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2007

First Posted

December 12, 2007

Study Start

February 1, 2003

Study Completion

March 1, 2005

Last Updated

December 12, 2007

Record last verified: 2007-12

Locations

JP(1)