to Compare the Effect of Two Types of IOLsNCT00571831
The Effect of a Blue Light Filtering IOL
A study testing intraocular lens implantation in people with to Compare the Effect of Two Types of IOLs and on the Incidence of Cystoid Macular Edema, run by Showa University at 1 site in Japan.
Trial summary
To compare the effect on blood retinal barrier disruption 3 and 12 months after implantation of either a blue light filtering intraocular lens(blue-filtering IOL) or an ultraviolet light filtering intraocular lens(UV-filtering IOL). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- to Compare the Effect of Two Types of IOLs, on the Incidence of Cystoid Macular Edema, After Cataract Surgery
- What is being tested?
- intraocular lens implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2003to Mar 2005
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cataract patients
- All eligible for intraocular lens implantation
Who cannot join
- Patients had undergone an intraocular operation
- Patients had hypertensive retinopathy
- Patients had diabetic retinopathy
- Patients had ange-related macular degeneration
- no observable fundus
- The cataract operation was more than 30 minutes in duration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Blue Light Filtering Intraocular Lens on Blood Retinal Barrier After Cataract Surgery
To compare the effect on blood retinal barrier disruption 3 and 12 months after implantation of either a blue light filtering intraocular lens(blue-filtering IOL) or an ultraviolet light filtering intraocular lens(UV-filtering IOL).
Read the detailed description
The following parameters were measured for evaluation of blood retinal barrier disruption.
- the incidence of macular leakage by fluorescence angiography (FA)
- the mean fluorescein concentration in the vitreous by fluorophotometry (VFP)
- the thickness of the macula by optical coherence tomography (OCT)
Results
- the incidence fo macular leakage decreased significantly from 24%(3 months) to 5% (12 months) in the blue-filtering IOL group (P<0.05), and was significantly lower compared with the UV-filtering IOL group at 12 months.
- the VFP significantly decreased in both group from 3 to 12 months.
- the OCT decreased from 175 (3 months) to 166 um (12 months) in the blue- filtering IOL group.
- Conditions
- to Compare the Effect of Two Types of IOLs, on the Incidence of Cystoid Macular Edema, After Cataract Surgery
- Being tested
- intraocular lens implantation
- Keywords
- macula edema, intraocular lens, prospective randomized parallel clinical design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraocular lens implantationProcedure or surgery
Also called a blue-filtering IOL (ENV-13, Menicon Co.Ltd, Japan), an UV-filtering IOL (ES-13, Menicon Co.Ltd, Japan)
Intraocular lens implantation
| Study group | Role | What they receive |
|---|---|---|
| letter | No intervention | a blue-filtering IOL an UV-filtering IOL Receives: Procedure: intraocular lens implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure FA, VEP and OCT.
Measured: At 3 and 12 months after IOL implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startFeb 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for to Compare the Effect of Two Types of IOLsStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Showa University
- Sponsor type
- University, hospital or other
- Investigators
- Ryohei Koide, MD, PhD, Study director, Department of Ophthalmology, School of Medicine, Showa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571831
- Sponsor's protocol ID
- Toshi-1
- Other IDs
- showa-IRB-02503
- Status last verified
- Dec 2007
- First submitted
- 11 Dec 2007
- Last updated
- 12 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Blue Light Filtering Intraocular Lens on Blood Retinal Barrier After Cataract Surgery
- ClinicalTrials.gov ID
- NCT00571831
- Acronym / sponsor ID
- Toshi-1
- Conditions
- to Compare the Effect of Two Types of IOLs, on the Incidence of Cystoid Macular Edema, After Cataract Surgery
- Keywords
- macula edema, intraocular lens, prospective randomized parallel clinical design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Showa UniversityUniversity, hospital or other
- Study start
- Feb 2003
- Study completion
- Mar 2005 (actual)
- First posted
- 12 Dec 2007 (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 compare the effect on blood retinal barrier disruption 3 and 12 months after implantation of either a blue light filtering intraocular lens(blue-filtering IOL) or an ultraviolet light filtering intraocular lens(UV-filtering IOL).
Detailed description
The following parameters were measured for evaluation of blood retinal barrier disruption.
- the incidence of macular leakage by fluorescence angiography (FA)
- the mean fluorescein concentration in the vitreous by fluorophotometry (VFP)
- the thickness of the macula by optical coherence tomography (OCT)
Results
- the incidence fo macular leakage decreased significantly from 24%(3 months) to 5% (12 months) in the blue-filtering IOL group (P<0.05), and was significantly lower compared with the UV-filtering IOL group at 12 months.
- the VFP significantly decreased in both group from 3 to 12 months.
- the OCT decreased from 175 (3 months) to 166 um (12 months) in the blue- filtering IOL group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| letter | No intervention | Procedure: intraocular lens implantationa blue-filtering IOL an UV-filtering IOL |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- cataract patients
- All eligible for intraocular lens implantation
Key exclusion criteria (6 listed)
- Patients had undergone an intraocular operation
- Patients had hypertensive retinopathy
- Patients had diabetic retinopathy
- Patients had ange-related macular degeneration
- no observable fundus
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 |
|---|---|---|
| intraocular lens implantationAlso: a blue-filtering IOL (ENV-13, Menicon Co.Ltd, Japan), an UV-filtering IOL (ES-13, Menicon Co.Ltd, Japan)Intraocular lens implantation | Procedure or surgery | letter |
Primary outcome
To measure FA, VEP and OCT.
Time frame: At 3 and 12 months after IOL implantation
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 12 Dec 2007.
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.
Ryohei Koide, MD, PhD study director
Department of Ophthalmology, School of Medicine, Showa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraocular lens implantation in people with to Compare the Effect of Two Types of IOLs and on the Incidence of Cystoid Macular Edema, run by Showa University at 1 site in Japan.
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 6 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 12 Dec 2007. 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 Japan. 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. 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?
To measure FA, VEP and OCT. (time frame: At 3 and 12 months after IOL implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2007.