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

Sponsor
Rassoul Akram Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01305616
Collaborator
(none)
34
1
2
20
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Phacoemulsification with yellow-tinted intraocular lens
  • Procedure: Phacoemulsification with yellow-tinted intraocular lens
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Study Start Date :
May 1, 2008
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Jan 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • bluelight filteing intraocular lens
  • Outcome Measures

    Primary Outcome Measures

    1. Mean deviation changes on SAP and SWAP before and after surgery [2.5months]

      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

    1. Visual Acuity changes measured with Snellen chart and Pattern Standard Deviation (PSD)and Foveal threshold (FT) changes on SAP and SWAP. [2.5 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01305616
    Other Study ID Numbers:
    • 975
    First Posted:
    Mar 1, 2011
    Last Update Posted:
    Mar 28, 2011
    Last Verified:
    Mar 1, 2008

    Study Results

    No Results Posted as of Mar 28, 2011