CataractNCT02513134
Intraocular Lens Power Calculation Using Pre- and Intra-operative Measurements
An observational study of Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial summary
Recently 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 allows measurements of the crystalline lens as well as the lens capsule itself after removing the crystalline lens of cataract patients… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract
- How many people
- 75 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2014to Jan 2015
- 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: The participants will be recruited by the clinical investigators in the Hanusch Hospital. Each subject has to meet the inclusion and exclusion criteria and to sign informed consent.
Who may be able to join
- Cataract
- Age 21 and older
- Able to understand the patient information
- willing to follow the orders and coming to 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 (pregnancy test will be taken preoperatively in women of reproductive age) or lactating women
Trial locations and contacts
1 site in 1 country.
Austria1 site
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
Vienna, 1140
About this study
Official title: Intraocular Lens Power Calculation Using Pre- and Intra-operative
Recently 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 allows measurements of the crystalline lens as well as the lens capsule itself after removing the crystalline lens of cataract patients intra-operatively. 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 12 and small changes of the IOL/crystalline lens can be detected 13.
In a previous study (EK-10-125-0710) that was recently published in the journal "Investigative Ophthalmology \& Visual Science" it was shown that intra-operative measurements of the anterior lens capsule improve the refractive outcome theoretically.14 However, in this previous study conventional eye models were used for IOL power calculation and only the intra-operative measurement replaced pre-operative ACD measurements.
Aim of this study is 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.
Read the detailed description
Since the introduction of optical biometry 1 (IOLMaster, Carl Zeiss Meditec AG, Jena, Germany), as a reliable non-contact measurement of the axial eye length the influence of the error of axial length measurement on the refractive error decreased from over 50% (when measured with applanation ultrasound) to 36%. The mean error of corneal power measurement is approximately 22% 2. These results show that the estimation of the post-operative intra-ocular lens (IOL) position and therefore the estimated anterior chamber depth (ACD) is nowadays the main source of error (35% 3 to 42% 2) 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 4, 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 (longer=more myopic eyes showed a larger ACD post-operatively). 5 These correlations were taken into account in later developed formulas (such as the Binkhorst II formula). Olsen et al. 6 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. Nowadays 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 correct would 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 2. 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 7 and later modified by Norrby 8, 9. It should be mentioned that IOL power calculations developed from theoretical calculations based on Gaussian optics 10 to regression formulas, such as the SRK formula 11 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.
Recently 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 allows measurements of the crystalline lens as well as the lens capsule itself after removing the crystalline lens of cataract patients intra-operatively. 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 12 and small changes of the IOL/crystalline lens can be detected 13.
In a previous study (EK-10-125-0710) that was recently published in the journal "Investigative Ophthalmology \& Visual Science" it was shown that intra-operative measurements of the anterior lens capsule improve the refractive outcome theoretically.14 However, in this previous study conventional eye models were used for IOL power calculation and only the intra-operative measurement replaced pre-operative ACD measurements.
Aim of this study is 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.
- Conditions
- Cataract
- Keywords
- IOL power calculations, Intraoperative, OCT, Refractive outcome, Biometry
- Medical subject headings
- Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
spherical equivalent in diopters between groups
Measured: 8 weeks postoperatively
Secondary outcomes (3)
Anterior chamber depth changes in mm between intra-operative OCT measurements and 1h post-operative ACD measurements
Measured: 1 hour postoperatively
Influence of the lens thickness on IOL power calculation
Measured: 8 weeks postoperatively
Influence of post-operative tilt in degrees and decentration in mm on IOL power calculation
Measured: 8 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionJan 2015
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
- Time perspective
- Prospective
- Enrolment
- 75 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, Prof Dr, Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513134
- Sponsor's protocol ID
- OC3
- Other IDs
- OC3
- Status last verified
- Jul 2015
- First submitted
- 2 Jun 2014
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Lens Power Calculation Using Pre- and Intra-operative
- ClinicalTrials.gov ID
- NCT02513134
- Acronym / sponsor ID
- OC3
- Conditions
- Cataract
- Keywords
- IOL power calculations, Intraoperative, OCT, Refractive outcome, Biometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 31 Jul 2015 (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.
Recently 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 allows measurements of the crystalline lens as well as the lens capsule itself after removing the crystalline lens of cataract patients intra-operatively. 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 12 and small changes of the IOL/crystalline lens can be detected 13.
In a previous study (EK-10-125-0710) that was recently published in the journal "Investigative Ophthalmology \& Visual Science" it was shown that intra-operative measurements of the anterior lens capsule improve the refractive outcome theoretically.14 However, in this previous study conventional eye models were used for IOL power calculation and only the intra-operative measurement replaced pre-operative ACD measurements.
Aim of this study is 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.
Detailed description
Since the introduction of optical biometry 1 (IOLMaster, Carl Zeiss Meditec AG, Jena, Germany), as a reliable non-contact measurement of the axial eye length the influence of the error of axial length measurement on the refractive error decreased from over 50% (when measured with applanation ultrasound) to 36%. The mean error of corneal power measurement is approximately 22% 2. These results show that the estimation of the post-operative intra-ocular lens (IOL) position and therefore the estimated anterior chamber depth (ACD) is nowadays the main source of error (35% 3 to 42% 2) 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 4, 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 (longer=more myopic eyes showed a larger ACD post-operatively). 5 These correlations were taken into account in later developed formulas (such as the Binkhorst II formula). Olsen et al. 6 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. Nowadays 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 correct would 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 2. 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 7 and later modified by Norrby 8, 9. It should be mentioned that IOL power calculations developed from theoretical calculations based on Gaussian optics 10 to regression formulas, such as the SRK formula 11 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.
Recently 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 allows measurements of the crystalline lens as well as the lens capsule itself after removing the crystalline lens of cataract patients intra-operatively. 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 12 and small changes of the IOL/crystalline lens can be detected 13.
In a previous study (EK-10-125-0710) that was recently published in the journal "Investigative Ophthalmology \& Visual Science" it was shown that intra-operative measurements of the anterior lens capsule improve the refractive outcome theoretically.14 However, in this previous study conventional eye models were used for IOL power calculation and only the intra-operative measurement replaced pre-operative ACD measurements.
Aim of this study is 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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will be recruited by the clinical investigators in the Hanusch Hospital. Each subject has to meet the inclusion and exclusion criteria and to sign informed consent.
Key inclusion criteria (5 listed)
- Cataract
- Age 21 and older
- Able to understand the patient information
- willing to follow the orders and coming to 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 (pregnancy test will be taken preoperatively in women of reproductive age) or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
spherical equivalent in diopters between groups
Time frame: 8 weeks postoperatively
3 secondary outcomes
Anterior chamber depth changes in mm between intra-operative OCT measurements and 1h post-operative ACD measurements
Time frame: 1 hour postoperatively
Influence of the lens thickness on IOL power calculation
Time frame: 8 weeks postoperatively
Influence of post-operative tilt in degrees and decentration in mm on IOL power calculation
Time frame: 8 weeks postoperatively
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 31 Jul 2015.
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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, Prof Dr 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?
An observational study of 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: finished, as of the sponsor's last update on 31 Jul 2015. 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?
spherical equivalent in diopters between groups (time frame: 8 weeks postoperatively). 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 31 Jul 2015.