CataractNCT01305616
Effect of Yellow-Tinted Intraocular Lens on Standard Automated Perimetry (SAP) and Short-wavelength Automated Perimetry (SWAP) in Patients With and Without Glaucoma
A study testing Phacoemulsification with yellow-tinted intraocular lens in people with Cataract and Glaucoma, run by Rassoul Akram Hospital at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- What is being tested?
- Phacoemulsification with yellow-tinted intraocular lens
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteIran
- Study dates
- May 2008to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Phacoemulsification with yellow-tinted intraocular lens
- Keywords
- Open angle Glaucoma, Yellow-tinted intraocular lens, Short-wavelength Automated Perimetry (SWAP), Standard Automated Perimetry (SAP), cataract
- Medical subject headings
- Cataract, Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification with yellow-tinted intraocular lensProcedure or surgery
Also called bluelight filteing 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 lensProcedure or surgery
Also called bluelight filteing 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1, glaucoma and cataract | Active comparator | Group1 were those patients with visually significant cataract (less than grade 2) and mild to moderate open angle glaucoma Receives: Procedure: Phacoemulsification with yellow-tinted intraocular lens |
| Group2, cataract patients | Sham comparator | This group included those patients with visually significant cataract and normal other eye examination. Receives: Procedure: Phacoemulsification with yellow-tinted intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2.5months
Secondary outcomes (1)
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.
Measured: 2.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startMay 2008
- Primary completionNov 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rassoul Akram Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Naveed Nilforushan, M.D, Principal investigator, Rassoul Akram hospital,Department of Ophthalmology,Iran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305616
- Sponsor's protocol ID
- 975
- Status last verified
- Mar 2008
- First submitted
- 28 Feb 2011
- Last updated
- 28 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20525530Kara-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.
PubMed 16863969
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Yellow-Tinted Intraocular Lens on Standard Automated Perimetry (SAP) and Short-wavelength Automated Perimetry (SWAP) in Patients With and Without Glaucoma
- ClinicalTrials.gov ID
- NCT01305616
- Acronym / sponsor ID
- 975
- Keywords
- Open angle Glaucoma, Yellow-tinted intraocular lens, Short-wavelength Automated Perimetry (SWAP), Standard Automated Perimetry (SAP), cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Rassoul Akram HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 1 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1, glaucoma and cataract | Active comparator | Procedure: Phacoemulsification with yellow-tinted intraocular lensGroup1 were those patients with visually significant cataract (less than grade 2) and mild to moderate open angle glaucoma |
| Group2, cataract patients | Sham comparator | Procedure: Phacoemulsification with yellow-tinted intraocular lensThis group included those patients with visually significant cataract and normal other eye examination. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phacoemulsification with yellow-tinted intraocular lensAlso: bluelight filteing intraocular lensPhacoemulsification 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) | Procedure or surgery | Group 1, glaucoma and cataract |
| Phacoemulsification with yellow-tinted intraocular lensAlso: bluelight filteing intraocular lensPhacoemulsification 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. | Procedure or surgery | Group2, cataract patients |
Primary outcome
Mean deviation changes on SAP and SWAP before and after surgery
Time frame: 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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2011.
- Background: PubMed 20525530Jang 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.
- Background: PubMed 16863969Kara-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naveed Nilforushan, M.D principal investigator
Rassoul Akram hospital,Department of Ophthalmology,Iran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phacoemulsification with yellow-tinted intraocular lens in people with Cataract and Glaucoma, run by Rassoul Akram Hospital at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean deviation changes on SAP and SWAP before and after surgery (time frame: 2.5months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01305616, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2011.