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

Not Applicable

Completed

• Conditions: Cataract; Glaucoma
• Interventions: Procedure: Phacoemulsification with yellow-tinted intraocular lens

• Registration Number: NCT01305616
• Lead Sponsor: Rassoul Akram Hospital

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.

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 Timeline

• Status Verified: 2008-03
• Study Start: 2008-05
• Primary Completion: 2009-11
• Study Completion: 2010-01
• Study First Submitted: 2011-02-28
• Study First Submitted QC: 2011-02-28
• Study First Posted: 2011-03-01
• Last Update Submitted: 2011-03-25
• Last Update Posted: 2011-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1, glaucoma and cataract	Phacoemulsification with yellow-tinted intraocular lens	Group1 were those patients with visually significant cataract (less than grade 2) and mild to moderate open angle glaucoma
Group2, cataract patients	Phacoemulsification with yellow-tinted intraocular lens	This group included those patients with visually significant cataract and normal other eye examination.

Primary Outcome Measures

Name	Time	Method
Mean deviation changes on SAP and SWAP before and after surgery	2.5months	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.

Secondary Outcome Measures

Name	Time	Method
Visual Acuity changes measured with Snellen chart and Pattern Standard Deviation (PSD)and Foveal threshold (FT) changes on SAP and SWAP.	2.5 months	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.

Trial Locations

Locations (1)

Rassoul Akram Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of