Cataract SenileNCT04580550
Axial Length Variability
A study testing Axial length variability in people with Cataract Senile, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
The accuracy of IOL calculation relies on the one hand on axial length measurements and on the other hand on corneal and lens thickness measurements. AL difference in pre and postoperative measurements may be caused by changes of lens parameters. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Cataract Senile
- What is being tested?
- Axial length variability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2019to 1 Mar 2020
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uneventful cataract surgery
- Age 21 and older
- Axial length 24.00 mm and bigger
- CT Asphina 409 M lens implanted
Who cannot join
- Intra- or postoperative complication
- Relevant other ophthalmic diseases that are likely to influence the measurement outcome (as: with severe corneal pathology, severe macular degeneration, severe diabetic retinopathy, dens cataract, PEX syndrome, previous ocular surgery or trauma)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Axial Length Changes Between Pre and Postoperative Measurements
The accuracy of IOL calculation relies on the one hand on axial length measurements and on the other hand on corneal and lens thickness measurements.
AL difference in pre and postoperative measurements may be caused by changes of lens parameters.
Aim of this study is to evaluate the magnitude of changes in pre and postoperative measurements of AL.
Read the detailed description
This is a prospective observational, controlled and unmasked study that would include patients which undergo cataract presurgical examination, after patient signed written informed consent. For each patient only one eye will be included.
In total 50 eyes of 50 patients will be include. Due to missing previous data, the sample size is an approximation.
Prior to surgery, slit lamp examination and cataract grading (LOCS) is performed. Routine biometry is performed using the IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany) and Heidelberg Anterion (Heidelberg Engineering, Germany) for AL and lens measurement.
Additionally, evaluation of tilt and decentration will be performed using Purkinje meter device.
Follow-up examination will be performed three months after surgery and will contain: AL and lens measurement using the two ss-OCT biometery devices, lens evaluation (tilt and decentration of the IOL) using the Purkinje meter. Refractive outcome will be evaluated by determining best-corrected visual acuity and subjective refraction.
In women of childbearing age, a pregnancy test will be performed before inclusion into the study.
Main outcome variable:
- Extend of AL difference between pre- and postoperative measurements in both devices
Additional outcome variables:
- Agreement between the two ss-OCT devices in AL measurement
- Evaluation of lens parameter in AL differences between pre- and postoperative measurements
- Limit of agreement in lens tilt and decentration using two ss-OCT devices and Purkinje meter
- Conditions
- Cataract Senile
- Being tested
- Axial length variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axial length variabilityOther
Biometry (axial length measurement)is performed using the IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany) and Heidelberg Anterion (Heidelberg Engineering, Germany) pre and postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Axial length variability | Other | Aim of this study is to evaluate the magnitude of changes in pre and postoperative measurements of AL. Receives: Other: Axial length variability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length variability
Evaluation of changes in axial length pre and post cataract surgery using two ss-OCT biometers
Measured: 3 months
Secondary outcomes (1)
Lens tilt and decentration
Evaluation of lens tilt and decantation using the Purkinje meter and two ss-OCT devices
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 posted8 Oct 2020
- Study start1 Nov 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SenileStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580550
- Sponsor's protocol ID
- Axial length variability
- Status last verified
- Oct 2020
- First submitted
- 30 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Axial Length Changes Between Pre and Postoperative Measurements
- ClinicalTrials.gov ID
- NCT04580550
- Acronym / sponsor ID
- Axial length variability
- Conditions
- Cataract Senile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 8 Oct 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.
The accuracy of IOL calculation relies on the one hand on axial length measurements and on the other hand on corneal and lens thickness measurements.
AL difference in pre and postoperative measurements may be caused by changes of lens parameters.
Aim of this study is to evaluate the magnitude of changes in pre and postoperative measurements of AL.
Detailed description
This is a prospective observational, controlled and unmasked study that would include patients which undergo cataract presurgical examination, after patient signed written informed consent. For each patient only one eye will be included.
In total 50 eyes of 50 patients will be include. Due to missing previous data, the sample size is an approximation.
Prior to surgery, slit lamp examination and cataract grading (LOCS) is performed. Routine biometry is performed using the IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany) and Heidelberg Anterion (Heidelberg Engineering, Germany) for AL and lens measurement.
Additionally, evaluation of tilt and decentration will be performed using Purkinje meter device.
Follow-up examination will be performed three months after surgery and will contain: AL and lens measurement using the two ss-OCT biometery devices, lens evaluation (tilt and decentration of the IOL) using the Purkinje meter. Refractive outcome will be evaluated by determining best-corrected visual acuity and subjective refraction.
In women of childbearing age, a pregnancy test will be performed before inclusion into the study.
Main outcome variable:
- Extend of AL difference between pre- and postoperative measurements in both devices
Additional outcome variables:
- Agreement between the two ss-OCT devices in AL measurement
- Evaluation of lens parameter in AL differences between pre- and postoperative measurements
- Limit of agreement in lens tilt and decentration using two ss-OCT devices and Purkinje meter
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axial length variability | Other | Other: Axial length variabilityAim of this study is to evaluate the magnitude of changes in pre and postoperative measurements of AL. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Uneventful cataract surgery
- Age 21 and older
- Axial length 24.00 mm and bigger
- CT Asphina 409 M lens implanted
Key exclusion criteria (3 listed)
- Intra- or postoperative complication
- Relevant other ophthalmic diseases that are likely to influence the measurement outcome (as: with severe corneal pathology, severe macular degeneration, severe diabetic retinopathy, dens cataract, PEX syndrome, previous ocular surgery or trauma)
- Pregnancy
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 |
|---|---|---|
| Axial length variabilityBiometry (axial length measurement)is performed using the IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany) and Heidelberg Anterion (Heidelberg Engineering, Germany) pre and postoperatively. | Other | Axial length variability |
Primary outcome
Axial length variability
Time frame: 3 months
Evaluation of changes in axial length pre and post cataract surgery using two ss-OCT biometers
1 secondary outcome
Lens tilt and decentration
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 8 Oct 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 Axial length variability in people with Cataract Senile, 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 3 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 8 Oct 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?
Axial length variability (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 8 Oct 2020.