Effect of Yellow-Tinted Intraocular Lens on Standard Automated Perimetry (SAP) and Short-wavelength Automated Perimetry (SWAP) in Patients With and Without Glaucoma

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Cataract
• Intervention / Treatment: Procedure: Phacoemulsification with yellow-tinted intraocular lens; Procedure: Phacoemulsification with yellow-tinted intraocular lens

Detailed Description

Glaucoma is mostly a disease of old people and is highly accompanied with cataract.Some of these patients may need to perform cataract surgery during the course of glaucoma. But in glaucoma patients, the effect of cataract surgery and/or type of implanted intraocular lens (IOL) on the results of specific visual field tests, like SWAP, is still not well studied.From the past decade, various yellow-tinted IOLs with the speculation of protecting the retinal photoreceptors and decreasing the incidence of age-related macular degeneration have been introduced.These blue-light-filtering IOLs contain a yellow chromophore that filters ultra violet (UV) and a larger part of the high-energetic visible blue-light between 380 and 500 nm. Based on previous studies yellow-tinted IOLs decrease the amount of light transmission to the retina which may theoretically affect perimetry results. This might be even more important in patients with glaucoma where the sensitivity of test locations has decreased per se.

Since early diagnosis of glaucoma and its progression is highly dependent on visual field results, it is important to evaluate the effect of these IOLs on perimetry, particularly on SWAP, in which the blue-light-filtering IOLs might interfere with its findings.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Rassoul Akram Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1, glaucoma and cataract; 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; 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); Other Names: bluelight filteing intraocular lens; Procedure: Phacoemulsification with yellow-tinted intraocular lens; 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.; Other Names: bluelight filteing intraocular lens
SHAM_COMPARATOR: Group2, cataract patients; This group included those patients with visually significant cataract and normal other eye examination.	Procedure: Phacoemulsification with yellow-tinted intraocular lens; 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); Other Names: bluelight filteing intraocular lens; Procedure: Phacoemulsification with yellow-tinted intraocular lens; 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.; Other Names: bluelight filteing intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity changes measured with Snellen chart and Pattern Standard Deviation (PSD)and Foveal threshold (FT) changes on SAP and SWAP.	visual acuity measurements were converted to logarithm minimum angle of resolution (logMAR).PSD (decibel)and FT(decibel) were obtained from the Humphrey visual field machine printout.	2.5 months

Collaborators and Investigators

• Sponsor: Rassoul Akram Hospital
• Investigators: Principal Investigator: Naveed Nilforushan, M.D, Rassoul Akram hospital,Department of Ophthalmology,Iran University of Medical Sciences

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): November 1, 2009
• Study Completion (ACTUAL): January 1, 2010

Study Registration Dates

• First Submitted: February 28, 2011
• First Submitted That Met QC Criteria: February 28, 2011
• First Posted (ESTIMATE): March 1, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 28, 2011
• Last Update Submitted That Met QC Criteria: March 25, 2011
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: cataract; Open angle Glaucoma; Yellow-tinted intraocular lens; Short-wavelength Automated Perimetry (SWAP); Standard Automated Perimetry (SAP)
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Lens Diseases; Glaucoma; Cataract
• Other Study ID Numbers: 975