CataractNCT05126368
Rotational Stability of the TECNIS Eyhance Toric
A study testing Cataract surgery in people with Cataract, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Evaluation of the rotational stability of a new toric intraocular lens (IOL), the TECNIS Eyhance toric II. Read more about this study
- Who is it for?
- Ages 21 to 110 years
- Conditions the study is for
- Cataract
- What is being tested?
- Cataract surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 29 Apr 2021to 29 Nov 2022
- 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 21 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract
- Age 21 and older
- Regular corneal astigmatism > 0.75 dioptres
- Written informed consent prior to surgery
Who cannot join
- Relevant other ophthalmic diseases such as pseudoexfoliation, traumatic cataract, corneal scars or other co-morbidities that could affect capsular bag stability (e.g. Marfan syndrome)
- High myopia (> 29 mm AL)
- Irregular corneal astigmatism on corneal topography
- Pregnancy (a pregnancy test will be taken preoperatively in women of reproductive age)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140
Johannes Zeilinger, MD, +43 1 91021 ext. 57564, office@viros.at
Manuel Ruiss, MSc, +43 1 91021 ext. 57564, office@viros.at
About this study
Official title: Rotational Stability of the TECNIS Eyhance Toric II IOL
Evaluation of the rotational stability of a new toric intraocular lens (IOL), the TECNIS Eyhance toric II.
Read the detailed description
With increasing demands of patients concerning the refractive outcome after cataract surgery, toric intraocular lenses (IOLs) have become more popular. Originally, toric IOLs were used mainly to correct corneal astigmatism in patients with high degrees of astigmatism. Since a couple of years, toric IOLs are available from numerous manufacturers to correct moderate or even low amounts of astigmatism which are much more prevalent. Only about 8% of the population has a corneal astigmatism of 2.0 D or more, while the incidence of a corneal astigmatism of 0.75 D or more is about 30%. The use of toric IOLs in this population results in less spectacle dependence due to the astigmatic correction.
Toric IOLs became the gold standard to correct corneal astigmatism during cataract surgery and rotational stability and axis alignment are critical to the efficacy of the surgical outcome. Misalignment may be caused intra- or postoperatively. Intraoperatively, misalignment may happen due to cyclotorsion of the eye in supine position or due to peribulbar anaesthesia and imprecision of positioning the IOL along the correct meridian in the capsular bag. This can be compensated for by preoperative corneal marking in the sitting position and meticulous positioning of the IOL during surgery. However, there are several other risk factors that influence rotational stability in the postoperative period, such as IOL design, haptic design and material, axial length, capsulorhexis size, capsular bag diameter and capsular bag shrinkage.
Long-term success of toric IOLs depends on rotational stability, nevertheless rotation mostly happens in the early postoperative period and once the anterior and posterior capsules fuse, IOL rotation is less frequent. A study by Kim et al. showed no significant differences in lens rotation between the early and late postoperative follow-up, and Kwartz et al. showed no significant differences between the two periods when different lens materials were used. Varsits et al. reported that rotation of toric IOLs is typically seen within the first hour after implantation.
It is known that tilt and decentration of the IOL can lead to a negative effect on optical performance and horizontal tilt induces against-the-rule-astigmatism. Every degree of rotation results in a loss of 3.3% of cylindrical power and misalignment of more than 10 degrees is considered an indication of surgical repositioning.
The aim of this study is therefore to evaluate the rotational stability of the TECNIS Eyhance toric II intraocular lens.
- Conditions
- Cataract
- Being tested
- Cataract surgery
- Keywords
- Cataract, Astigmatism, Toric 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.
Cataract surgeryOther
During cataract surgery the Eyhance toric II intraocular lens will be implanted in one eye of the patient
| Study group | Role | What they receive |
|---|---|---|
| Eyhance toric II | Experimental | The Eyhance toric II intraocular lens will be implanted in one of the patients eyes during cataract surgery Receives: Other: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotational stability
The change in the intraocular lens axis (given in degrees) of the Eyhance toric IOL of one eye will be analysed by taking photographs of the IOL and will be compared between the different study time points.
Measured: 12 months
Secondary outcomes (1)
Distance visual acuity
Distance visual acuity will be determined using ETDRS-charts in a distance of 4 metres and differences in refraction will be compared between the different study time points.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start29 Apr 2021
- Primary completion29 Apr 2022 (estimated)
- Study completion29 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, MD, Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126368
- Sponsor's protocol ID
- Eyhance Toric
- Status last verified
- Nov 2021
- First submitted
- 2 Nov 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zeilinger J, Hienert J, Ruiss M, Pilwachs C, Findl O. Rotational stability of a new toric intraocular lens with an advanced optical profile. J Cataract Refract Surg. 2023 Jun 1;49(6):584-588. doi: 10.1097/j.jcrs.0000000000001158.
PubMed 36745852
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotational Stability of the TECNIS Eyhance Toric II IOL
- ClinicalTrials.gov ID
- NCT05126368
- Acronym / sponsor ID
- Eyhance Toric
- Conditions
- Cataract
- Keywords
- Cataract, Astigmatism, Toric intraocular lens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 29 Apr 2022 (estimated)
- Study completion
- 29 Nov 2022 (estimated)
- First posted
- 19 Nov 2021 (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.
Evaluation of the rotational stability of a new toric intraocular lens (IOL), the TECNIS Eyhance toric II.
Detailed description
With increasing demands of patients concerning the refractive outcome after cataract surgery, toric intraocular lenses (IOLs) have become more popular. Originally, toric IOLs were used mainly to correct corneal astigmatism in patients with high degrees of astigmatism. Since a couple of years, toric IOLs are available from numerous manufacturers to correct moderate or even low amounts of astigmatism which are much more prevalent. Only about 8% of the population has a corneal astigmatism of 2.0 D or more, while the incidence of a corneal astigmatism of 0.75 D or more is about 30%. The use of toric IOLs in this population results in less spectacle dependence due to the astigmatic correction.
Toric IOLs became the gold standard to correct corneal astigmatism during cataract surgery and rotational stability and axis alignment are critical to the efficacy of the surgical outcome. Misalignment may be caused intra- or postoperatively. Intraoperatively, misalignment may happen due to cyclotorsion of the eye in supine position or due to peribulbar anaesthesia and imprecision of positioning the IOL along the correct meridian in the capsular bag. This can be compensated for by preoperative corneal marking in the sitting position and meticulous positioning of the IOL during surgery. However, there are several other risk factors that influence rotational stability in the postoperative period, such as IOL design, haptic design and material, axial length, capsulorhexis size, capsular bag diameter and capsular bag shrinkage.
Long-term success of toric IOLs depends on rotational stability, nevertheless rotation mostly happens in the early postoperative period and once the anterior and posterior capsules fuse, IOL rotation is less frequent. A study by Kim et al. showed no significant differences in lens rotation between the early and late postoperative follow-up, and Kwartz et al. showed no significant differences between the two periods when different lens materials were used. Varsits et al. reported that rotation of toric IOLs is typically seen within the first hour after implantation.
It is known that tilt and decentration of the IOL can lead to a negative effect on optical performance and horizontal tilt induces against-the-rule-astigmatism. Every degree of rotation results in a loss of 3.3% of cylindrical power and misalignment of more than 10 degrees is considered an indication of surgical repositioning.
The aim of this study is therefore to evaluate the rotational stability of the TECNIS Eyhance toric II intraocular lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eyhance toric II | Experimental | Other: Cataract surgeryThe Eyhance toric II intraocular lens will be implanted in one of the patients eyes during cataract surgery |
Who may qualify
- Ages
- 21 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cataract
- Age 21 and older
- Regular corneal astigmatism > 0.75 dioptres
- Written informed consent prior to surgery
Key exclusion criteria (4 listed)
- Relevant other ophthalmic diseases such as pseudoexfoliation, traumatic cataract, corneal scars or other co-morbidities that could affect capsular bag stability (e.g. Marfan syndrome)
- High myopia (> 29 mm AL)
- Irregular corneal astigmatism on corneal topography
- Pregnancy (a pregnancy test will be taken preoperatively in women of reproductive age)
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 |
|---|---|---|
| Cataract surgeryDuring cataract surgery the Eyhance toric II intraocular lens will be implanted in one eye of the patient | Other | Eyhance toric II |
Primary outcome
Rotational stability
Time frame: 12 months
The change in the intraocular lens axis (given in degrees) of the Eyhance toric IOL of one eye will be analysed by taking photographs of the IOL and will be compared between the different study time points.
1 secondary outcome
Distance visual acuity
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Derived from this study: PubMed 36745852Zeilinger J, Hienert J, Ruiss M, Pilwachs C, Findl O. Rotational stability of a new toric intraocular lens with an advanced optical profile. J Cataract Refract Surg. 2023 Jun 1;49(6):584-588. doi: 10.1097/j.jcrs.0000000000001158.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
Vienna Institute for Research in Ocular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cataract surgery in people with Cataract, run by Vienna Institute for Research in Ocular Surgery 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 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: status not confirmed, as of the sponsor's last update on 19 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johannes Zeilinger, MD (+43 1 91021 ext. 57564, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotational stability (time frame: 12 months). 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 NCT05126368, which also lists 1 linked publication.
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 19 Nov 2021.