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

Cataract Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305616
• Other study ID #: 975
• Status: Completed
• Phase: N/A
• First received: February 28, 2011
• Last updated: March 25, 2011
• Start date: May 2008
• Est. completion date: January 2010

Study information

• Verified date: March 2008
• Source: Rassoul Akram Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cataract
• Glaucoma

Intervention

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)
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Rassoul Akram Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Rassoul Akram Hospital

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (2)

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. — View Citation

Kara-Júnior 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No