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

This study has been completed.
Sponsor:
Information provided by:
Rassoul Akram Hospital
ClinicalTrials.gov Identifier:
NCT01305616
First received: February 28, 2011
Last updated: March 25, 2011
Last verified: March 2008
  Purpose

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.


Condition Intervention
Cataract
Glaucoma
Procedure: Phacoemulsification with yellow-tinted intraocular lens
Procedure: Phacoemulsification with yellow-tinted intraocular lens

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Rassoul Akram Hospital:

Primary Outcome Measures:
  • Mean deviation changes on SAP and SWAP before and after surgery [ Time Frame: 2.5months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 34
Study Start Date: May 2008
Study Completion Date: January 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1, glaucoma and cataract
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
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 Name: bluelight filteing intraocular lens
Sham Comparator: Group2, cataract patients
This group included those patients with visually significant cataract and normal other eye examination.
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.
Other Name: bluelight filteing intraocular lens

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01305616

Locations
Iran, Islamic Republic of
Rassoul Akram Hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Rassoul Akram Hospital
Investigators
Principal Investigator: Naveed Nilforushan, M.D Rassoul Akram hospital,Department of Ophthalmology,Iran University of Medical Sciences
  More Information

Publications:
Responsible Party: Naveed Nilforushan, Rassoul Akram Hospital,Ophthalmic Research Center,Department of Ophthalmology,Iran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01305616     History of Changes
Other Study ID Numbers: 975
Study First Received: February 28, 2011
Last Updated: March 25, 2011
Health Authority: Iran: Ethics Committee

Keywords provided by Rassoul Akram Hospital:
Open angle Glaucoma
Yellow-tinted intraocular lens
Short-wavelength Automated Perimetry (SWAP)
Standard Automated Perimetry (SAP)
cataract

Additional relevant MeSH terms:
Cataract
Glaucoma
Lens Diseases
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on September 22, 2014