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CataractPhase 4NCT01505816

Visual Outcomes After Implantation of a New Multifocal Intraocular Lens

A Phase 4 study testing Multifocal Intraocular Lens (RAYNER M-FLEX T TORIC IOL) in people with Cataract, run by Hospital Oftalmologico de Brasilia at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective nonrandomized study comprised patients with cataract, corneal astigmatism, and motivation for spectacle independence. In all cases, a Rayner M-flex® T toric Intraocular Lens will be implanted in the capsular bag. Read more about this study

Who is it for?
Ages 55 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Cataract
What is being tested?
Multifocal Intraocular Lens (RAYNER M-FLEX T TORIC IOL)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBrazil
Study dates
Oct 2011to Jan 2012
Phase
Phase 4
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 55 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Cataract
  • Any race
  • Either gender
  • Diagnosis of cataracts both eyes
  • Pre-existing physical conditions that could skew visual results, such as Diabetes, Retinal detachment, Macular degeneration, or Cancer
  • Subjects must have > 1.00 diopter of astigmatism

Who cannot join

  • Central endothelial cell count less than 2000 cells/mm2 glaucoma or intraocular pressure greater than 21 mmHg amblyopia
  • Retinal abnormalities
  • Diabetes mellitus steroid or immunosuppressive treatment
  • Connective tissue diseases

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital Oftalmologico Brasilia

    Brasília, Federal District, 70200670

Other trials in Brazil

About this study

Official title: Visual Outcomes After Implantation of a New Refractive Toric Multifocal Intraocular Lens

This prospective nonrandomized study comprised patients with cataract, corneal astigmatism, and motivation for spectacle independence. In all cases, a Rayner M-flex® T toric Intraocular Lens will be implanted in the capsular bag. Three months postoperatively, distance, intermediate, and near visual acuities; spherical equivalent; residual refractive astigmatism; defocus curve; and contrast sensitivity will be evaluated. A patient-satisfaction and visual phenomena questionnaire will also be administered.

Read the detailed description

Postoperative evaluation was performed at 3 months. The uncorrected and corrected distance visual acuity were assessed using the 100% contrast Early Treatment Diabetic Retinopathy Study chart, uncorrected intermediate visual acuity at 70 cm, and uncorrected near visual acuity at 40 cm; a binocular defocus curve was constructed using the ETDRS chart at 4 m and adding to the patient's manifest refraction +2.50 to -5.00 D sphere in 0.50 increments. The cylinder axis of the Intraocular lens (IOL) was measured at the slitlamp using the beam protractor after full mydriasis. The mean of the absolute values of degrees the intraocular lens was off axis was determined.

Contrast sensitivity was measured using the CSV-1000 HGT instrument (VectorVision, Inc.), which presents a translucent chart divided into 4 cycles with spatial frequencies of 3, 6, 12 and 18 cycles per degree. The background illumination of the translucent chart does not depend on room lighting. All measurements were obtained under mesopic (5 cd/m2) and photopic (85 cd/m2) conditions. The examinations were performed unilaterally at a distance of 2.5 m with Best-corrected visual acuity (BCVA) and an undilated pupil. All measurements were performed under the same conditions.

Patient satisfaction and quality of life were assessed by a simple questionnaire. Patients were interviewed 3 months postoperative. Patients were asked about visual disturbances, visual lifestyle activities, spectacle use, and satisfaction with the procedure.

Conditions
Cataract
Being tested
Multifocal Intraocular Lens (RAYNER M-FLEX T TORIC IOL)
Keywords
Cataract, Vision, Intraocular lens, Multifocal, Toric
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multifocal Intraocular Lens (RAYNER M-FLEX T TORIC IOL)Device

    Also called RAYNER M-FLEX T TORIC IOL

    Multifocal IOL implantation

Study groups in NCT01505816
Study groupRoleWhat they receive
ToricNo interventionMultifocal Toric IOL implantation
Receives: Device: Multifocal Intraocular Lens (RAYNER M-FLEX T TORIC IOL)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Performance After Implantation of a Toric Multifocal Refractive Intraocular Lens

    Postoperative evaluation will be performed at 3 months. The uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) will be assessed using the 100% contrast ETDRS chart; a binocular defocus curve will be constructed using the ETDRS chart at 4 m.

    Measured: 3 months postoperative

Secondary outcomes (2)

  1. Contrast sensitivity

    Contrast sensitivity will be measured using the CSV-1000 HGT instrument (VectorVision, Inc.), which presents a translucent chart divided into 4 cycles with spatial frequencies of 3, 6, 12 and 18 cycles per degree (cpd). The background illumination of the translucent chart does not depend on room lighting. All measurements will be obtained under mesopic (5 cd/m2) and photopic (85 cd/m2) conditions. The examinations will be performed unilaterally at a distance of 2.5 m with BCVA and an undilated pupil. All measurements will be performed under the same conditions.

    Measured: 3 months

  2. Patient satisfaction

    Patient satisfaction and quality of life will be assessed by a simple questionnaire. Patients will be interviewed 3 months postoperative. Patients will be asked about visual disturbances, visual lifestyle activities, spectacle use, and satisfaction with the procedure.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2012 (estimated)
  2. Study startOct 2011
  3. Primary completionNov 2011
  4. Study completionJan 2012

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01505816
Sponsor's protocol ID
HOB05
Other IDs
HOBBrasilia05
Status last verified
Jan 2012
First submitted
3 Jan 2012
Last updated
9 Jan 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Alio JL, Pinero DP, Tomas J, Plaza AB. Vector analysis of astigmatic changes after cataract surgery with implantation of a new toric multifocal intraocular lens. J Cataract Refract Surg. 2011 Jul;37(7):1217-29. doi: 10.1016/j.jcrs.2010.12.064.

    PubMed 21700102

  • Mojzis P, Pinero DP, Studeny P, Tomas J, Korda V, Plaza AB, Alio JL. Comparative analysis of clinical outcomes obtained with a new diffractive multifocal toric intraocular lens implanted through two types of corneal incision. J Refract Surg. 2011 Sep;27(9):648-57. doi: 10.3928/1081597X-20110506-01. Epub 2011 May 20.

    PubMed 21598872

  • Visser N, Nuijts RM, de Vries NE, Bauer NJ. Visual outcomes and patient satisfaction after cataract surgery with toric multifocal intraocular lens implantation. J Cataract Refract Surg. 2011 Nov;37(11):2034-42. doi: 10.1016/j.jcrs.2011.05.041. Epub 2011 Sep 22.

    PubMed 21940140

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Multifocal Intraocular Lens (RAYNER M-FLEX T TORIC IOL) in people with Cataract, run by Hospital Oftalmologico de Brasilia at 1 site in Brazil.

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 6 inclusion and 4 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 9 Jan 2012. 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 Brazil. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Visual Performance After Implantation of a Toric Multifocal Refractive Intraocular Lens (time frame: 3 months postoperative). 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 NCT01505816, which also lists 3 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 9 Jan 2012.

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