NCT01305616

Brief Summary

To investigate the effect of yellow-tinted IOLs on the Short Wave-length Automated Perimetry (SWAP) and Standard Automated Perimetry (SAP) in patients with and without glaucoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2008

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

May 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2011

Completed
Last Updated

March 28, 2011

Status Verified

March 1, 2008

Enrollment Period

1.5 years

First QC Date

February 28, 2011

Last Update Submit

March 25, 2011

Conditions

CataractGlaucoma

Keywords

Open angle GlaucomaYellow-tinted intraocular lensShort-wavelength Automated Perimetry (SWAP)Standard Automated Perimetry (SAP)cataract

Outcome Measures

Primary Outcomes (1)

  • Mean deviation changes on SAP and SWAP before and after surgery

    Mean deviation(decibel) which is the average change of visual field points from normal age- matched group ,was obtained from visual field print out. Its value is from 0 to -30 decibels where the lower values means the point is more damaged.

    2.5months

Secondary Outcomes (1)

  • Visual Acuity changes measured with Snellen chart and Pattern Standard Deviation (PSD)and Foveal threshold (FT) changes on SAP and SWAP.

    2.5 months

Study Arms (2)

Group 1, glaucoma and cataract

ACTIVE COMPARATOR

Group1 were those patients with visually significant cataract (less than grade 2) and mild to moderate open angle glaucoma

Procedure: Phacoemulsification with yellow-tinted intraocular lens

Group2, cataract patients

SHAM COMPARATOR

This group included those patients with visually significant cataract and normal other eye examination.

Procedure: Phacoemulsification with yellow-tinted intraocular lens

Interventions

Phacoemulsification with yellow-tinted intraocular lensPROCEDURE

Phacoemulsification is a kind of cataract surgery using ultrasound machine. Yellow-tinted intraocular lens are a sort of lens with the ability to filter blue and ultraviolet spectrum of light (380-500 nanometer)

Also known as: bluelight filteing intraocular lens
Group 1, glaucoma and cataract

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In group 1, visually significant cataract associated with well controlled mild to moderate open angle glaucoma (intraocular pressure \< 18 with maximally-tolerated medical treatment)and no history of previous intraocular surgeries
  • In group 2- Normal ophthalmic examination other than visually significant cataract

You may not qualify if:

  • Diabetes mellitus
  • neurological disease which may affect the results of visual field
  • known systemic medication with involvement on visual field
  • spherical refractive error less than -5 and more than +5 diopter
  • cylindrical correction more than 3 diopter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rassoul Akram Hospital

Tehran, Tehran Province, Iran

Location

Related Publications (2)

  • Jang SY, Ohn YH, Kim SW. Effect of yellow-tinted intraocular lenses on short-wavelength automated perimetry. Am J Ophthalmol. 2010 Aug;150(2):243-247.e1. doi: 10.1016/j.ajo.2010.02.023.

    PMID: 20525530BACKGROUND

  • Kara-Junior N, Jardim JL, de Oliveira Leme E, Dall'Col M, Susanna R Jr. Effect of the AcrySof Natural intraocular lens on blue-yellow perimetry. J Cataract Refract Surg. 2006 Aug;32(8):1328-30. doi: 10.1016/j.jcrs.2006.03.033.

    PMID: 16863969BACKGROUND

MeSH Terms

Conditions

CataractGlaucomaGlaucoma, Open-Angle

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesOcular Hypertension

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Naveed Nilforushan, M.D

    Rassoul Akram hospital,Department of Ophthalmology,Iran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 28, 2011

First Posted

March 1, 2011

Study Start

May 1, 2008

Primary Completion

November 1, 2009

Study Completion

January 1, 2010

Last Updated

March 28, 2011

Record last verified: 2008-03

Locations

IR(1)