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

NCT ID: NCT01305616

Last Updated: 2011-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-01-31

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Group 1, glaucoma and cataract

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

Group Type ACTIVE_COMPARATOR

Phacoemulsification with yellow-tinted intraocular lens

Intervention Type 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)

Group2, cataract patients

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

Group Type SHAM_COMPARATOR

Phacoemulsification with yellow-tinted intraocular lens

Intervention Type 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.

Interventions

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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)

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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bluelight filteing intraocular lens bluelight filteing intraocular lens

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rassoul Akram Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rassoul Akram Hospital,Ophthalmic Research Center,Department of Ophthalmology,Iran University of Medical Sciences

Principal Investigators

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Naveed Nilforushan, M.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Rassoul Akram Hospital

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type BACKGROUND
PMID: 20525530 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16863969 (View on PubMed)

Other Identifiers

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975

Identifier Type: -

Identifier Source: org_study_id

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