Clinical trial NCT01305616: Effect of Yellow-Tinted Intraocular Lens on Standard Automated Perimetry (SAP) and Short-wavelength Automated Perimetry (SWAP) in Patients With and Without Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Glaucoma
Keywords: Open angle Glaucoma
Yellow-tinted intraocular lens
Short-wavelength Automated Perimetry (SWAP)
Standard Automated Perimetry (SAP)
cataract
Lead sponsor: Rassoul Akram Hospital
Sponsor class: OTHER
First posted: 2011-03-01
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean deviation changes on SAP and SWAP before and after surgery
timeFrame: 2.5months
Secondary outcomes:
measure: Visual Acuity changes measured with Snellen chart and Pattern Standard Deviation (PSD)and Foveal threshold (FT) changes on SAP and SWAP.
timeFrame: 2.5 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rassoul Akram Hospital
Study officials:
affiliation: Rassoul Akram hospital,Department of Ophthalmology,Iran University of Medical Sciences
name: Naveed Nilforushan, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.