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Completed

NCT Number: NCT01305616

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.

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Key information

Conditions

Cataract Eye Diseases Glaucoma Glaucoma, Open-Angle Lens Diseases Ocular Hypertension

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rassoul Akram Hospital

Tehran, Tehran Province, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phacoemulsification with yellow-tinted intraocular lens

Procedure

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

Primary outcomes

  1. Mean deviation changes on SAP and SWAP before and after surgery

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rassoul Akram Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Mar 1, 2011
Registry last updated
Mar 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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