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CataractNCT04345380

Rotational Stability of the Acrysof, Tecnis and Envista Intraocular Lenses

A study testing Implantation of an Alcon Acrysof SN60WF intraocular lens, Implantation of an AMO Tecnis ZCB00 intraocular lens and Implantation of an Envista MX60 intraocular lens in people with Cataract and Astigmatism, run by Medical University of Vienna at 1 site in Austria.

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

Brief Summary: Age-related cataract is the main cause of impaired vision in the elderly population worldwide. In the UK, more than half of people who are over 65 years old have some cataract development in one or both eyes. Read more about this study

Who is it for?
Ages 40 to 90 years
Conditions the study is for
Cataract, Astigmatism
What is being tested?
Implantation of an Alcon Acrysof SN60WF intraocular lens, Implantation of an AMO Tecnis ZCB00 intraocular lens and Implantation of an Envista MX60 intraocular lens
Could I receive a placebo?
No, everyone receives an active treatment
How many people
199 participants
Where
1 siteAustria
Study dates
9 Jun 2015to 18 Aug 2017
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Uni- or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
  • Need for spherical IOL correction between 10.00 and 30.00 D
  • Pupil dilation of ≥ 6.5 mm
  • Age 40 and older

Who cannot join

  • Corneal abnormality
  • Pseudoexfoliation
  • Preceding ocular surgery or trauma
  • Uncontrolled glaucoma
  • Proliferative diabetic retinopathy
  • Iris neovascularization
Show all 12Show fewer
  • History of uveitis/iritis
  • Microphthalmus
  • Recurrent intraocular inflammation of unknown etiology
  • Blind fellow eye
  • Uncontrolled systemic or ocular disease
  • Pregnancy and lactation

Trial locations and contacts

1 site in 1 country.

Austria1 site
  • Medical University of Vienna Allgemeines Krankenhaus

    Vienna, 1090

Other trials in Austria

About this study

Brief Summary:

Age-related cataract is the main cause of impaired vision in the elderly population worldwide. In the UK, more than half of people who are over 65 years old have some cataract development in one or both eyes. The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted. It is estimated that around 10 million cataract operations are performed around the world each year. Cataract operations are generally very successful, with a low risk of serious complications.

Read more

During the past two decades, cataract surgery underwent tremendous change and modernisation resulting in today's small incision phacoemulsification surgery and a safe technique with a short rehabilitation time for the patient. Traditional spherical monofocal intraocular lenses (IOLs) restore best-corrected vision and may lessen the need for spectacles. These IOLs correct only the spherical portion of the total refractive error and do not correct corneal astigmatism. Astigmatism is a visually disabling refractive error affecting the general population, especially those with cataract. At least 15% to 20% of cataract patients have 1.5 diopters (D) or more of corneal or refractive astigmatism. With increased patient expectations, the trend is not only to remove the cataract but also to address the problem of pre-existing astigmatism at the time of surgery.

Surgical-induced astigmatism can be reduced by smaller incisions, i.e. microincision cataract surgery (MICS), which by definition is surgery performed through incisions smaller than 2.0 mm, reducing the need for suturing. This results in better corneal optical quality, thus improving visual outcomes. There are also other surgical options to correct preexisting astigmatism during cataract surgery like: selectively positioning of the phacoemulsification incision; astigmatic keratotomy with corneal or limbal relaxing incisions; excimer laser refractive procedures such as photorefractive keratectomy, laser in situ keratomileusis, and laser-assisted subepithelial keratectomy; or implanting pseudophakic toric posterior chamber intraocular lenses (IOLs).

Toric IOLs have been shown to result in good visual and refractive outcomes. Combined with MICS, these IOLs can allow effective correction of cylindrical errors intraoperatively, improving visual quality and thus leading to spectacle independence. Plate haptic and loop haptic toric IOLs have been considered for about a decade but have been associated with postoperative rotational instability. Rotation of a toric lens from its intended orientation degrades its corrective power, with approximately 3.3% loss of cylindrical power for every degree off axis. A misorientation of approximately 30° negates the effectiveness of astigmatic correction, and a misorientation of more than 30° may induce additional astigmatism. Although some patients are asymptomatic despite induced astigmatism, others experience symptoms such as blurred or distorted vision, headache, fatigue, eyestrain, squinting, or eye discomfort. Thus, IOL orientation stability is an essential goal in toric IOL design.

RATIONALE

The purpose of this study is to assess and compare the axial IOL rotation and optical quality (refraction, visual acuity, decentration and tilt) and capsular bag reaction after micro-incision surgery with an IOL implantation in cataract patients - Acrysof SN60WF, Tecnis ZCB00 \& Envista MX60 IOL

Being tested
Implantation of an Alcon Acrysof SN60WF intraocular lens, Implantation of an AMO Tecnis ZCB00 intraocular lens, Implantation of an Envista MX60 intraocular lens
Medical subject headings
Cataract, Astigmatism

What participants receive

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

  • Implantation of an Alcon Acrysof SN60WF intraocular lensOther

    Patients suffering from senile cataract getting replaced their human crystalline cataractous lens

  • Implantation of an AMO Tecnis ZCB00 intraocular lensOther

    Patients suffering from senile cataract getting replaced their human crystalline cataractous lens

  • Implantation of an Envista MX60 intraocular lensOther

    Patients suffering from senile cataract getting replaced their human crystalline cataractous lens

Study groups in NCT04345380
Study groupRoleWhat they receive
Acrysof RotationActive comparatorImplantation of the Acrysof SN60WF Intraocular lens to the 0 ±10, 45± 10, 90±10 or 135± axis.
Receives: Other: Implantation of an Alcon Acrysof SN60WF intraocular lens
Tecnis RotationActive comparatorImplantation of the Tecnis ZCB00 Intraocular lens to the 0 ±10, 45± 10, 90±10 or 135± axis.
Receives: Other: Implantation of an AMO Tecnis ZCB00 intraocular lens
Envista RotationActive comparatorImplantation of the Envista MX60 Intraocular lens to the 0 ±10, 45± 10, 90±10 or 135± axis.
Receives: Other: Implantation of an Envista MX60 intraocular lens

What is being measured

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

  1. Rotational stability from End of Surgery to 6 months

    Change in axis position of an intraocular lens Alcon SN60WF, AMO Tecnis ZCB00 or Bausch\&Lomb Envista MX60 from end of surgery (baseline axis) to 1 hour, 1 week, 1 month and 4-7 months (end of study visit). The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)

    Measured: 4-7 months

Secondary outcomes (2)
  1. Decentration

    Decentration of the intraocular lens Alcon SN60WF, AMO Tecnis ZCB00 or Bausch\&Lomb Envista MX60 will be measured with a Purkinje Meter. Decentration will be described as "Decentration in milimeter"

    Measured: 4 to 7 months

  2. Tilt

    Tilt of the intraocular lens Alcon SN60WF, AMO Tecnis ZCB00 or Bausch\&Lomb Envista MX60 will be measured with a Purkionje Meter. Tilt will be described as "Tilt in degrees at a certain axis"

    Measured: 4 to 7 months

Timeline

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

  1. First posted14 Apr 2020
  2. Study start9 Jun 2015
  3. Primary completion18 Aug 2017
  4. Study completion18 Aug 2017

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04345380
Sponsor's protocol ID
1746/2014
Status last verified
Apr 2020
First submitted
8 Apr 2020
Last updated
14 Apr 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Implantation of an Alcon Acrysof SN60WF intraocular lens, Implantation of an AMO Tecnis ZCB00 intraocular lens and Implantation of an Envista MX60 intraocular lens in people with Cataract and Astigmatism, run by Medical University of Vienna at 1 site in Austria.

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 4 inclusion and 12 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 14 Apr 2020. 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 Austria. 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?

Rotational stability from End of Surgery to 6 months (time frame: 4-7 months). 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 14 Apr 2020.

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