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.
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
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
- Conditions
- Cataract, Astigmatism
- 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 group | Role | What they receive |
|---|---|---|
| Acrysof Rotation | Active comparator | Implantation 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 Rotation | Active comparator | Implantation 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 Rotation | Active comparator | Implantation 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.
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)
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
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.
- First posted14 Apr 2020
- Study start9 Jun 2015
- Primary completion18 Aug 2017
- Study completion18 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupert Menapace, Medical University of Vienna
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotational Stability of the Acrysof, Tecnis and Envista Intraocular Lenses
- ClinicalTrials.gov ID
- NCT04345380
- Acronym / sponsor ID
- 1746/2014
- Conditions
- Cataract, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 9 Jun 2015 (actual)
- Primary completion
- 18 Aug 2017 (actual)
- Study completion
- 18 Aug 2017 (actual)
- First posted
- 14 Apr 2020 (actual)
- 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.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acrysof Rotation | Active comparator | Other: Implantation of an Alcon Acrysof SN60WF intraocular lensImplantation of the Acrysof SN60WF Intraocular lens to the 0 ±10, 45± 10, 90±10 or 135± axis. |
| Tecnis Rotation | Active comparator | Other: Implantation of an AMO Tecnis ZCB00 intraocular lensImplantation of the Tecnis ZCB00 Intraocular lens to the 0 ±10, 45± 10, 90±10 or 135± axis. |
| Envista Rotation | Active comparator | Other: Implantation of an Envista MX60 intraocular lensImplantation of the Envista MX60 Intraocular lens to the 0 ±10, 45± 10, 90±10 or 135± axis. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Corneal abnormality
- Pseudoexfoliation
- Preceding ocular surgery or trauma
- Uncontrolled glaucoma
- Proliferative diabetic retinopathy
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 |
|---|---|---|
| Implantation of an Alcon Acrysof SN60WF intraocular lensPatients suffering from senile cataract getting replaced their human crystalline cataractous lens | Other | Acrysof Rotation |
| Implantation of an AMO Tecnis ZCB00 intraocular lensPatients suffering from senile cataract getting replaced their human crystalline cataractous lens | Other | Tecnis Rotation |
| Implantation of an Envista MX60 intraocular lensPatients suffering from senile cataract getting replaced their human crystalline cataractous lens | Other | Envista Rotation |
Primary outcome
Rotational stability from End of Surgery to 6 months
Time frame: 4-7 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°)
2 secondary outcomes
Decentration
Time frame: 4 to 7 months
Tilt
Time frame: 4 to 7 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 14 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.