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

Study Overview
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Brief Summary
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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
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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.

Conditions
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Cataract, Glaucoma

Intervention / Treatment
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* Procedure: Phacoemulsification with yellow-tinted intraocular lens
* Procedure: Phacoemulsification with yellow-tinted intraocular lens


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1, glaucoma and cataract<br>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<br>* 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)<br>* Other names: bluelight filteing intraocular lens;|
| Sham Comparator: Group2, cataract patients<br>This group included those patients with visually significant cataract and normal other eye examination. | Procedure: Phacoemulsification with yellow-tinted intraocular lens<br>* 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.<br>* Other names: bluelight filteing intraocular lens;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open angle Glaucoma, Yellow-tinted intraocular lens, Short-wavelength Automated Perimetry (SWAP), Standard Automated Perimetry (SAP), cataract