CataractNCT03749486
High Resolution Immersion Ultrasound for iIOL Power Calculation
A study testing Cataract surgery in people with Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial summary
Assess is the additional use of high resolution immersion ultrasound measurements improve the refractive outcome after cataract surgery. Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Cataract
- What is being tested?
- Cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2018to 1 Jan 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 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract
- Age 21 and older
- Able to understand the patient information
- Willing to follow the instructions and attend all follow-up visits
- Willing to sign informed consent prior to surgery
Who cannot join
- Relevant other ophthalmic diseases that are likely to reduce the refractive outcome, such as pseudoexfoliation syndrome, traumatic cataract, severe corneal scars
- Previous ocular surgeries on the study eye
- Patients who are not able to cooperate, with eccentric fixation or insufficient ability to fixate (tremor, nystagmus)
- Pregnant or lactating women (pregnancy testing will be performed preoperatively on 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
Sahand Amir-Asgari, MD, 01 910 21-57557, office@viros.at
Julius Hienert, MD, 01 910 21-57564, office@viros.at
About this study
Official title: To Assess if Using a High Resolution Immersion Ultrasound Measurement Improves Intraocular Lens Power Calculation
Assess is the additional use of high resolution immersion ultrasound measurements improve the refractive outcome after cataract surgery.
Read the detailed description
Since the beginning of biometry, immersion ultrasound was shown to be accurate and reproducible. It is important to distinguish between immersion ultrasound techniques and contact ultrasound. The later was shown to be less accurate and examiner dependent.
Although immersion ultrasound has been improved significantly and novel high resolution ultrasound devices are available, the drawback of this technique is that measurement s take longer compared to optical biometry. The advantage of immersion ultrasound is that structures behind the iris are visible, whereas in optical biometry only structures within the pupil are visible.
Immersion ultrasound as well optical biometry can be used to calculate the needed power of an intraocular lens (IOL) to achieve the aimed post-operative refraction. Although IOL power calculation improved within the last decades, refractive surprises occur, especially in cases with very short eyes.
The estimation of the post-operative IOL position and therefore the estimated anterior chamber depth (ACD) is presently the main source of error (35% to 42%) in IOL power calculation and therefore for the refractive outcome of the patients after cataract surgery. Early IOL power calculation formulae, such as the Binkhorst I formula, used a fixed ACD value to predict the position of the IOL, but the refractive results were not appropriate because the post-operative position of the IOL varied significantly between patients. Later observations showed a correlation between the axial eye length and the post-operative ACD (more myopic eyes showed a larger ACD post-operatively). These correlations were taken into account in later developed formulas (such as the Binkhorst II formula). Olsen et al. measured the post-operative ACD and substituted the predicted post-operative ACD with the true, post-operative ACD in each case. The result after correcting the IOL position was a highly accurate IOL power calculation, where no fudge factors were needed. Presently the pre-operatively measured ACD is taken into account for several IOL power calculation formulas, such as the Haigis formula, the Holladay II formula and the Olsen formula. However, this new generation of formulas use the pre-operative ACD, without considering the thickness of the crystalline lens. The ACD is measured as the distance between the anterior surface of the cornea (anatomically speaking this should be the posterior surface of the cornea, but in an optical context, as in IOL power calculations, the anterior surface is used) and the anterior surface of the crystalline lens . Therefore the thickness of the crystalline lens has a significant impact on the predicted post-operative position of the IOL. This parameter was first taken into account by Olsen and later modified by Norrby.
It should be mentioned that IOL power calculations developed from theoretical calculations based on Gaussian optics to regression formulas, such as the SRK formula that uses retrospective data of a large number of patients. All these findings suggest that proper measurements not only of the dimensions of the crystalline lens but also of the lens capsule after removing the crystalline lens are necessary to improve IOL power calculation.
A prototype of a combination of an anterior segment OCT (VISANTE; Carl Zeiss Meditec AG) and an operating microscope (OPMI 200; Carl Zeiss Meditec AG) was introduced that allowed measurements of the crystalline lens as well as the lens capsule itself after removing the crystalline lens of cataract patients intraoperatively. This device uses OCT technology to create high resolution B-scans (=images) of the anterior segment of the eye. The OCT was shown to be highly reproducible for ACD measurements pre-operatively and small changes of the IOL/crystalline lens can be detected.
This prototype set-up was used in a previous study published in the journal "Investigative Ophthalmology \& Visual Science". It was shown that intra-operative measurements of the anterior lens capsule were a better predictor for the post-operative lens position than other factors and could improve the refractive outcome theoretically. Furthermore it was shown that intra-operatively measured anterior chamber depth is useful to predict refractive outcome using fourth-generation formulae. A further study aimed to observe, whether the postoperative refractive outcome could be improved theoretically by using both pre- and intra-operative measurements for retrospective IOL power calculation with new eye models.
In a recent study a high resolution swept-source OCT was used to perform the measurements and results were very promising (DIATHLAS; Carl Zeiss Meditec AG, Germany).
However, disadvantage of swept-source OCT technology is that the measured area is only within the pupil, but structures behind the iris cannot be visualised.
Most recent findings suggest that measuring the equator of the lens capsule and the cilliary body could improve IOL power calculation.
One CE marked device that allows measurements behind the iris is the ArcScan Insight 100 scanner. This immersion ultrasound device is a precision high frequency device for imaging and biometry of the eye. A 20-60 MHz transducer scans the eye although its curvature approximates the anterior ocular surface. During this process the device produces images with 1 micron resolution of the cornea or the anterior segment. In addition, measurements can also be made of the anatomic structures comprising the anterior of the eye such as anterior chamber depth, angle-to-angle width, and sulcus-to-sulcus width, and pathologic structures, such as solid masses and cysts.
- Conditions
- Cataract
- Being tested
- Cataract surgery
- Keywords
- Cataract surgery, High resolution immersion ultrasound
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryProcedure or surgery
Cataract surgery will be done following ArcScan measurement
| Study group | Role | What they receive |
|---|---|---|
| ArcScan | Experimental | High resolution immersion ultrasound measurement before Cataract surgery Receives: Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean absolute error in refractive outcome
The difference in refractive error will be measured using auto- and subjective refraction
Measured: 12 months
Secondary outcomes (2)
Anterior chamber depth and lens thickness measurement
Anterior chamber depth and lens thickness will be measured using the IOL Master 700
Measured: 12 months
IOL tilt and decentration
IOL tilt and decentration will be assessed using the Purkinjemeter
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 posted21 Nov 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749486
- Sponsor's protocol ID
- ArcScan
- Status last verified
- Nov 2018
- First submitted
- 19 Nov 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess if Using a High Resolution Immersion Ultrasound Measurement Improves Intraocular Lens Power Calculation
- ClinicalTrials.gov ID
- NCT03749486
- Acronym / sponsor ID
- ArcScan
- Conditions
- Cataract
- Keywords
- Cataract surgery, High resolution immersion ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 21 Nov 2018 (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.
Assess is the additional use of high resolution immersion ultrasound measurements improve the refractive outcome after cataract surgery.
Detailed description
Since the beginning of biometry, immersion ultrasound was shown to be accurate and reproducible. It is important to distinguish between immersion ultrasound techniques and contact ultrasound. The later was shown to be less accurate and examiner dependent.
Although immersion ultrasound has been improved significantly and novel high resolution ultrasound devices are available, the drawback of this technique is that measurement s take longer compared to optical biometry. The advantage of immersion ultrasound is that structures behind the iris are visible, whereas in optical biometry only structures within the pupil are visible.
Immersion ultrasound as well optical biometry can be used to calculate the needed power of an intraocular lens (IOL) to achieve the aimed post-operative refraction. Although IOL power calculation improved within the last decades, refractive surprises occur, especially in cases with very short eyes.
The estimation of the post-operative IOL position and therefore the estimated anterior chamber depth (ACD) is presently the main source of error (35% to 42%) in IOL power calculation and therefore for the refractive outcome of the patients after cataract surgery. Early IOL power calculation formulae, such as the Binkhorst I formula, used a fixed ACD value to predict the position of the IOL, but the refractive results were not appropriate because the post-operative position of the IOL varied significantly between patients. Later observations showed a correlation between the axial eye length and the post-operative ACD (more myopic eyes showed a larger ACD post-operatively). These correlations were taken into account in later developed formulas (such as the Binkhorst II formula). Olsen et al. measured the post-operative ACD and substituted the predicted post-operative ACD with the true, post-operative ACD in each case. The result after correcting the IOL position was a highly accurate IOL power calculation, where no fudge factors were needed. Presently the pre-operatively measured ACD is taken into account for several IOL power calculation formulas, such as the Haigis formula, the Holladay II formula and the Olsen formula. However, this new generation of formulas use the pre-operative ACD, without considering the thickness of the crystalline lens. The ACD is measured as the distance between the anterior surface of the cornea (anatomically speaking this should be the posterior surface of the cornea, but in an optical context, as in IOL power calculations, the anterior surface is used) and the anterior surface of the crystalline lens . Therefore the thickness of the crystalline lens has a significant impact on the predicted post-operative position of the IOL. This parameter was first taken into account by Olsen and later modified by Norrby.
It should be mentioned that IOL power calculations developed from theoretical calculations based on Gaussian optics to regression formulas, such as the SRK formula that uses retrospective data of a large number of patients. All these findings suggest that proper measurements not only of the dimensions of the crystalline lens but also of the lens capsule after removing the crystalline lens are necessary to improve IOL power calculation.
A prototype of a combination of an anterior segment OCT (VISANTE; Carl Zeiss Meditec AG) and an operating microscope (OPMI 200; Carl Zeiss Meditec AG) was introduced that allowed measurements of the crystalline lens as well as the lens capsule itself after removing the crystalline lens of cataract patients intraoperatively. This device uses OCT technology to create high resolution B-scans (=images) of the anterior segment of the eye. The OCT was shown to be highly reproducible for ACD measurements pre-operatively and small changes of the IOL/crystalline lens can be detected.
This prototype set-up was used in a previous study published in the journal "Investigative Ophthalmology \& Visual Science". It was shown that intra-operative measurements of the anterior lens capsule were a better predictor for the post-operative lens position than other factors and could improve the refractive outcome theoretically. Furthermore it was shown that intra-operatively measured anterior chamber depth is useful to predict refractive outcome using fourth-generation formulae. A further study aimed to observe, whether the postoperative refractive outcome could be improved theoretically by using both pre- and intra-operative measurements for retrospective IOL power calculation with new eye models.
In a recent study a high resolution swept-source OCT was used to perform the measurements and results were very promising (DIATHLAS; Carl Zeiss Meditec AG, Germany).
However, disadvantage of swept-source OCT technology is that the measured area is only within the pupil, but structures behind the iris cannot be visualised.
Most recent findings suggest that measuring the equator of the lens capsule and the cilliary body could improve IOL power calculation.
One CE marked device that allows measurements behind the iris is the ArcScan Insight 100 scanner. This immersion ultrasound device is a precision high frequency device for imaging and biometry of the eye. A 20-60 MHz transducer scans the eye although its curvature approximates the anterior ocular surface. During this process the device produces images with 1 micron resolution of the cornea or the anterior segment. In addition, measurements can also be made of the anatomic structures comprising the anterior of the eye such as anterior chamber depth, angle-to-angle width, and sulcus-to-sulcus width, and pathologic structures, such as solid masses and cysts.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ArcScan | Experimental | Procedure: Cataract surgeryHigh resolution immersion ultrasound measurement before Cataract surgery |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cataract
- Age 21 and older
- Able to understand the patient information
- Willing to follow the instructions and attend all follow-up visits
- Willing to sign informed consent prior to surgery
Key exclusion criteria (4 listed)
- Relevant other ophthalmic diseases that are likely to reduce the refractive outcome, such as pseudoexfoliation syndrome, traumatic cataract, severe corneal scars
- Previous ocular surgeries on the study eye
- Patients who are not able to cooperate, with eccentric fixation or insufficient ability to fixate (tremor, nystagmus)
- Pregnant or lactating women (pregnancy testing will be performed preoperatively on 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 surgeryCataract surgery will be done following ArcScan measurement | Procedure or surgery | ArcScan |
Primary outcome
Difference in mean absolute error in refractive outcome
Time frame: 12 months
The difference in refractive error will be measured using auto- and subjective refraction
2 secondary outcomes
Anterior chamber depth and lens thickness measurement
Time frame: 12 months
IOL tilt and decentration
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 21 Nov 2018.
- 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.
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 Prim. Prof. Dr. Oliver Findl, MBA 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 5 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 21 Nov 2018. 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 Sahand Amir-Asgari, MD (01 910 21-57557, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean absolute error in refractive outcome (time frame: 12 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 21 Nov 2018; AzTrials last refreshed its copy on 6 Nov 2026.