CataractNCT02155959
Performance of a Single-piece Toric Acrylic Intraocular Lens
An observational study of Cataract and Corneal Astigmatism, run by Prim. Prof. Dr. Oliver Findl, MBA.
Trial summary
Abstract Purpose: To evaluate the visual performance and rotational stability of the Tecnis Toric one-piece IOL (AMO, USA) during the first 3 post-operative months Design: Prospective single center study Setting: VIROS - Vienna Institute for Research in Ocular Surgery, a Karl Landsteiner Institute, Hanusch Hospitel… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract, Corneal Astigmatism
- What is being tested?
- toric intraocular lens
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Dec 2012
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who were scheduled for cataract surgery and had corneal astigmatism
Who may be able to join
- corneal astigmatism between 1.0 D and 3.0 D
- cataract
Who cannot join
- irregular astigmatism
- forme fruste Keratoconus
- corneal scars
- phakodonesis
- pseudoexfoliation syndrome
- traumatic cataract
About this study
Official title: Rotational Stability of a Single-piece Toric Acrylic Intraocular Lens: a Pilot Study
Abstract Purpose: To evaluate the visual performance and rotational stability of the Tecnis Toric one-piece IOL (AMO, USA) during the first 3 post-operative months Design: Prospective single center study Setting: VIROS - Vienna Institute for Research in Ocular Surgery, a Karl Landsteiner Institute, Hanusch Hospitel, Vienna, Austria Methods: In this prospective study patients with age-related cataract and corneal astigmatism of 1.0 to 3.0 D measured with the IOL-Master 500 (Carl Zeiss Meditec AG, Germany) were included. Pre-operatively, rotating Scheimpflug scans (Pentacam HR, Oculus, Germany) were performed and the cornea was marked in the sitting position at the slit lamp. Patients recieved a single-piece toric hydrophobic acrylic IOL (Tecnis Toric, AMO, USA). Immediately and 3 months after surgery retroillumination photographs were taken to assess the rotational stability of the IOL. Additionally, Autorefraction (Topcon, USA), subjective refraction, uncorrected and distance corrected visual acuity, keratometry, Scheimpflug and ocular wavefront (WASCA, Carl Zeiss Meditec AG, Germany) measurements were performed at the 3 months follow-up.
Read the detailed description
Whereas first designs of toric intraocular lenses (toric IOLs) in the early 1990's showed an IOL rotation of more than 30° in one fifth of the patients, modern toric IOLs typically show a mean absolute rotation of 3° to 5°, which would result in a loss of about 10% to 15% of the astigmatism reducing effect of the toric IOL.
Rotational stability of a toric IOL depends on the interaction between the toric IOL and the posterior capsule, whereas misalignment of the toric IOL (defined in this study as the difference between the 3 months postoperatively measured axis of the toric IOL and the intended axis) depends on several factors additionally to rotational stability. Intraoperatively, misalignment may happen due to cyclotorsion of the eye in the lying position or due to peribulbar anaesthesia, and due to imprecision of the surgeon when positioning of the IOL relative to the intended meridian. Both these imprecisions can be dealt with by pre-operative marking of the eye in the sitting position and diligence by the surgeon. Postoperatively, the IOL may rotate because it is undersized for the capsule bag or due to the capsule shrinkage that takes place during fibrotic contraction of the bag in the postoperative period. Since most current IOLs are slightly oversized for the capsule bag, the former is observed rarely and would be more likely in long eyes which tend to have a larger capsule bag diameter. However, capsule bag shrinkage is thought to induce rotation in IOLs with open-loop haptics due to the asymmetry of the haptic design. Typical IOL haptic designs that improve rotational stability are either plate haptic IOLs or special Z-haptic shaped open-loop haptics that attempt to counteract the rotational effect of compression of the shrinking bag. However, both of these IOL designs are thought to have downsides. The former seems to have an increased risk of posterior capsule opacification due to a less effective lens epithelial barrier effect of the optic edge and may also show more rotation in the bag immediately after surgery due to the shorter haptic overall length. The latter IOL design, such as the Z-haptic IOL, is cumbersome to implant and may be prone to damage during implantation.
Aim of this study was to evaluate the rotational stability of a novel single-piece hydrophobic acrylic toric IOL with a C-haptic design.
- Conditions
- Cataract, Corneal Astigmatism
- Being tested
- toric intraocular lens
- Keywords
- astigmatism, cataract, toric, 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.
toric intraocular lensDevice
Also called Tecnis toric IOL (Abott Medical Optics, USA)
toric intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| one group | one group receiving a toric intraocular lens during cataract surgery. Receives: Device: toric intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotational stability of the investigated toric lens
Rotation of the investigated intraocular lens using a photograph technique (retroillumination images) immediately after surgery and 3 months later.
Measured: 3 months
Secondary outcomes (1)
reduction in post-operative higher order aberrations
the investigated intraocular lens was proven to reduce some higher order aberrations (this is a refractive problem caused by the cornea). It was shown that the investigated intraocular lens was reducind higher order aberrations in our study population.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startMar 2011
- Primary completionDec 2012
- Study completionDec 2012
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, MD, MBA, Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155959
- Sponsor's protocol ID
- toric_rotation_acrylic
- Status last verified
- Jun 2014
- First submitted
- 12 Jun 2013
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotational Stability of a Single-piece Toric Acrylic Intraocular Lens: a Pilot Study
- ClinicalTrials.gov ID
- NCT02155959
- Acronym / sponsor ID
- toric_rotation_acrylic
- Conditions
- Cataract, Corneal Astigmatism
- Keywords
- astigmatism, cataract, toric, lens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Jun 2014 (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.
Abstract Purpose: To evaluate the visual performance and rotational stability of the Tecnis Toric one-piece IOL (AMO, USA) during the first 3 post-operative months Design: Prospective single center study Setting: VIROS - Vienna Institute for Research in Ocular Surgery, a Karl Landsteiner Institute, Hanusch Hospitel, Vienna, Austria Methods: In this prospective study patients with age-related cataract and corneal astigmatism of 1.0 to 3.0 D measured with the IOL-Master 500 (Carl Zeiss Meditec AG, Germany) were included. Pre-operatively, rotating Scheimpflug scans (Pentacam HR, Oculus, Germany) were performed and the cornea was marked in the sitting position at the slit lamp. Patients recieved a single-piece toric hydrophobic acrylic IOL (Tecnis Toric, AMO, USA). Immediately and 3 months after surgery retroillumination photographs were taken to assess the rotational stability of the IOL. Additionally, Autorefraction (Topcon, USA), subjective refraction, uncorrected and distance corrected visual acuity, keratometry, Scheimpflug and ocular wavefront (WASCA, Carl Zeiss Meditec AG, Germany) measurements were performed at the 3 months follow-up.
Detailed description
Whereas first designs of toric intraocular lenses (toric IOLs) in the early 1990's showed an IOL rotation of more than 30° in one fifth of the patients, modern toric IOLs typically show a mean absolute rotation of 3° to 5°, which would result in a loss of about 10% to 15% of the astigmatism reducing effect of the toric IOL.
Rotational stability of a toric IOL depends on the interaction between the toric IOL and the posterior capsule, whereas misalignment of the toric IOL (defined in this study as the difference between the 3 months postoperatively measured axis of the toric IOL and the intended axis) depends on several factors additionally to rotational stability. Intraoperatively, misalignment may happen due to cyclotorsion of the eye in the lying position or due to peribulbar anaesthesia, and due to imprecision of the surgeon when positioning of the IOL relative to the intended meridian. Both these imprecisions can be dealt with by pre-operative marking of the eye in the sitting position and diligence by the surgeon. Postoperatively, the IOL may rotate because it is undersized for the capsule bag or due to the capsule shrinkage that takes place during fibrotic contraction of the bag in the postoperative period. Since most current IOLs are slightly oversized for the capsule bag, the former is observed rarely and would be more likely in long eyes which tend to have a larger capsule bag diameter. However, capsule bag shrinkage is thought to induce rotation in IOLs with open-loop haptics due to the asymmetry of the haptic design. Typical IOL haptic designs that improve rotational stability are either plate haptic IOLs or special Z-haptic shaped open-loop haptics that attempt to counteract the rotational effect of compression of the shrinking bag. However, both of these IOL designs are thought to have downsides. The former seems to have an increased risk of posterior capsule opacification due to a less effective lens epithelial barrier effect of the optic edge and may also show more rotation in the bag immediately after surgery due to the shorter haptic overall length. The latter IOL design, such as the Z-haptic IOL, is cumbersome to implant and may be prone to damage during implantation.
Aim of this study was to evaluate the rotational stability of a novel single-piece hydrophobic acrylic toric IOL with a C-haptic design.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group | – | Device: toric intraocular lensone group receiving a toric intraocular lens during cataract surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who were scheduled for cataract surgery and had corneal astigmatism
Key inclusion criteria (2 listed)
- corneal astigmatism between 1.0 D and 3.0 D
- cataract
Key exclusion criteria (6 listed)
- irregular astigmatism
- forme fruste Keratoconus
- corneal scars
- phakodonesis
- pseudoexfoliation syndrome
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 |
|---|---|---|
| toric intraocular lensAlso: Tecnis toric IOL (Abott Medical Optics, USA)toric intraocular lens | Device | one group |
Primary outcome
Rotational stability of the investigated toric lens
Time frame: 3 months
Rotation of the investigated intraocular lens using a photograph technique (retroillumination images) immediately after surgery and 3 months later.
1 secondary outcome
reduction in post-operative higher order aberrations
Time frame: 3 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 4 Jun 2014.
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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.
Oliver Findl, MD, MBA principal investigator
Vienna Institute for Research in Ocular Surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Corneal Astigmatism, run by Prim. Prof. Dr. Oliver Findl, MBA.
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 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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 of the investigated toric lens (time frame: 3 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 4 Jun 2014.