CataractOCT IOLNCT00532051
Intraocular Lens Power Calculation After Laser Refractive Surgery Based on Optical Coherence Tomography
An observational study of Cataract, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The long-term goal of this project is to utilize very high-speed optical coherence tomography (OCT) technology to guide surgical treatments of corneal diseases. OCT is well known for its exquisite resolution, but until recently it has not had sufficient speed to capture the shape of the cornea because of eye motion… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- OCT measurements
- Type of treatment
- Medical device
- How many people
- 690 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jul 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients seeking cataract surgery with implantation of monofocal IOLs (including toric IOLs) but not multifocal or accommodative IOLs.
Who may be able to join
- The subjects will be patients seeking cataract surgery with implantation of monofocal IOLs (including toric IOLs) but not multifocal or accommodative IOLs.
- Subjects will have had post-laser vision correction (LVC) such as previous LASIK, PRK, laser sub-epithelial keratectomy (LASEK), epi-LASIK (surface laser ablation under a microkeratome-created epithelial flap) or RK. The post-LVC group will be subdivided into those who have previous hyperopic LVC and those who have previous myopic LVC.
Who cannot join
- Inability to give informed consent.
- Inability to maintain stable fixation for OCT imaging.
- Inability to commit to required visits to complete the study.
- Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Casey Eye Institute, Oregon Health & Science University
Portland, Oregon, 97239
Humberto Martinez, COT, 503-494-7712, martinhu@ohsu.edu
Denny Romfh, OD, 503-494-4351, romfhd@ohsu.edu
About this study
Official title: Guiding the Treatment of Anterior Eye Diseases With Optical Coherence Tomography
The long-term goal of this project is to utilize very high-speed optical coherence tomography (OCT) technology to guide surgical treatments of corneal diseases. OCT is well known for its exquisite resolution, but until recently it has not had sufficient speed to capture the shape of the cornea because of eye motion during OCT scanning. The development of Fourier-domain (FD) OCT technology has made the requisite speed possible.
The objective of this project is to develop methods for imaging the cornea with an FD-OCT system that will precisely measure corneal shape and use this information to guide surgery. Cataract surgery in patients with previous laser vision correction often leads to significant near- or far-sightedness, a problem that could be resolved by using a more accurate intraocular lens power selection formula based on the measurement of corneal refractive power with OCT.
Read the detailed description
This study is about an imaging method called Optical Coherence Tomography (OCT) which provides detailed cross-sectional (layered) views of structures in the eye. The OCT system scans a beam of light across the eye to take a picture. OCT provides a more detailed image than other imaging methods of the eye such as ultrasound, CT scan (computed tomography) and MRI (magnetic resonance imaging). In addition, OCT imaging does not touch the eye. OCT is routinely used in imaging structures in the back of the eye (retina) and cornea. This study uses high-speed FDA approved OCT systems. The proposed research plan is a combination of clinical studies and software development to be performed synergistically. Clinical studies will provide OCT images for image processing software development and testing. The image processing software will provide automated measurement of anatomic parameters essential for clinical use.
Cataract extraction and IOL implantation is the most common eye surgery. The power of the IOL implant is calculated from 2 measurements: the axial eye length (AL) and keratometric power (K). The Holladay II formula also uses the external corneal diameter ("white-to-white" or WTW) and anterior chamber depth (ACD). These formulae work well (±0.5D) in normal eyes. However, these formulae can leads to biased and unpredictable refractive results in eyes that had refractive surgery procedures such as LASIK, PRK, and RK. With a large number of patients undergoing refractive surgery every year, the problem is becoming more severe.
The conventional IOL formulae fail because several inherent assumptions are no longer true in the eye that had refractive surgery. These assumptions are: 1) The corneal refractive power is uniform. 2) The anterior and posterior corneal power has a fixed relationship such that the overall corneal refractive power can be calculated from the anterior keratometry (or topography) using the keratometric index. 3) The position of IOL can be predicted by K with or without additional information such as WTW and ACD.
Relative to the posterior curvature, the anterior curvature becomes flatter after myopic correction and steeper after hyperopic correction with LASIK or PRK. To adapt the conventional IOL formulae to this situation, most surgeons use rigid contact lens over-refraction to calculate an "effective K." However, the accuracy of refraction in cataract patients is poor due to poor vision. Alternatively, one could use a historical method to calculate the effective K from pre-refractive surgery values. However, those measurements are often no longer available. If many years have lapsed, the historical value may no longer accurately reflect the current shape of the cornea.
The axial position of the IOL is determined by the positions of lens zonules and capsule which is in turn related to the corneal curvature (K) in the normal eye. A flatter cornea (lower K) is usually associated with a larger anterior segment, where the lens apparatus is located further back. A more complex model that also uses a separately measured white-to-white corneal diameter may be even more accurate. In post-refractive surgery eyes, however, K is altered and no longer has the normal relationship with the size of the eye. One way to get around this is to enter the pre-refractive surgery K. However, this historical information is not always available. We believe that a better solution would be use an entirely different approach that does not depend on the 3 above assumptions at all. Since OCT can separately measure the corneal anterior and posterior surfaces and AC and lens dimensions, we believe it has the potential of being the basis of a much better IOL calculation formula.
Previously we developed a method to measure both anterior and posterior corneal surface curvatures and obtain more accurate corneal power measurements than conventional keratometry, which only measures the anterior surface. This was the basis of an OCT-based intraocular lens (IOL) formula that showed better results than other formulas for post-myopic LASIK cataract surgery. However, this formula was only on par with the best regression-based formulas in eyes with previous hyperopic LASIK or radial keratectomy (RK), because IOL position prediction error and higher-order corneal aberration limited the accuracy of optical calculations in in these cases. We propose to improve IOL position prediction by using the long-range OCT that can image the entire anterior eye and accurately measure the lens equatorial position. We propose to more accurately determine corneal power in the presence of high aberration by developing ray tracing techniques based on ultrahigh-speed OCT mapping of corneal surfaces. Together, these new methods should improve IOL selection and refractive outcome for all types of eyes. In addition, we will develop a new OCT-based toric IOL formula that takes into account posterior corneal astigmatism, which is ignored in conventional keratometry.
- Conditions
- Cataract
- Being tested
- OCT measurements
- Keywords
- cataract, lasik, laser refractive surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT measurementsDevice
Also called Manufacturer/Name OCT Technology 510(K), Optovue/RTVue-CAM Fourier-domain K071250, Bioptigen/Bioptigen Fourier-domain K063343, Zeiss/Visante Time-domain K051789
This study is about a new imaging method to study the front part of the eye. This imaging method is called Optical Coherence Tomography (OCT) which provides detailed cross-sectional (layered) views of structures in the eye. The OCT system scans a beam of light across the eye to take a picture. OCT provides a more detailed image than other imaging methods of the eye such as ultrasound, CT scan (computed tomography), and MRI (magnetic resonance imaging). In addition, OCT imaging does not touch the eye. OCT is routinely used in imaging structures in the back of the eye (retina) and cornea. This study uses high-speed FDA approved OCT systemsThe measurements from the OCT systems are used in selecting IOL power.
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL power prediction (baseline visit)
Subjects will be assessed at study enrollment, and a prediction of the most suitable IOL power will be made. Predicted IOL power will be measured in Diopters.
Measured: Study enrollment
IOL power prediction error (post-operative visit)
Subjects will be assessed no later than 6-months following cataract surgery to assess accuracy of IOL power prediction at baseline visit. IOL power error will be measured in Diopters.
Measured: No later than 6-months following cataract surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startApr 2011
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (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.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 690 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, David Huang, Oregon Health and Science University
- Investigators
- David Huang, MD, PhD, Principal investigator, Casey Eye Institute, Oregon Health & Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532051
- Sponsor's protocol ID
- OHSU IRB #00006612-IOL
- Other IDs
- 7R01EY018184-04
- Acronym
- OCT IOL
- Status last verified
- Feb 2024
- First submitted
- 18 Sep 2007
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang L, Tang M, Huang D, Weikert MP, Koch DD. Comparison of Newer Intraocular Lens Power Calculation Methods for Eyes after Corneal Refractive Surgery. Ophthalmology. 2015 Dec;122(12):2443-9. doi: 10.1016/j.ophtha.2015.08.037. Epub 2015 Oct 14.
PubMed 26459996
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guiding the Treatment of Anterior Eye Diseases With Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT00532051
- Acronym / sponsor ID
- OCT IOL / OHSU IRB #00006612-IOL
- Conditions
- Cataract
- Keywords
- cataract, lasik, laser refractive surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 690 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Apr 2011
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 19 Sep 2007 (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.
The long-term goal of this project is to utilize very high-speed optical coherence tomography (OCT) technology to guide surgical treatments of corneal diseases. OCT is well known for its exquisite resolution, but until recently it has not had sufficient speed to capture the shape of the cornea because of eye motion during OCT scanning. The development of Fourier-domain (FD) OCT technology has made the requisite speed possible.
The objective of this project is to develop methods for imaging the cornea with an FD-OCT system that will precisely measure corneal shape and use this information to guide surgery. Cataract surgery in patients with previous laser vision correction often leads to significant near- or far-sightedness, a problem that could be resolved by using a more accurate intraocular lens power selection formula based on the measurement of corneal refractive power with OCT.
Detailed description
This study is about an imaging method called Optical Coherence Tomography (OCT) which provides detailed cross-sectional (layered) views of structures in the eye. The OCT system scans a beam of light across the eye to take a picture. OCT provides a more detailed image than other imaging methods of the eye such as ultrasound, CT scan (computed tomography) and MRI (magnetic resonance imaging). In addition, OCT imaging does not touch the eye. OCT is routinely used in imaging structures in the back of the eye (retina) and cornea. This study uses high-speed FDA approved OCT systems. The proposed research plan is a combination of clinical studies and software development to be performed synergistically. Clinical studies will provide OCT images for image processing software development and testing. The image processing software will provide automated measurement of anatomic parameters essential for clinical use.
Cataract extraction and IOL implantation is the most common eye surgery. The power of the IOL implant is calculated from 2 measurements: the axial eye length (AL) and keratometric power (K). The Holladay II formula also uses the external corneal diameter ("white-to-white" or WTW) and anterior chamber depth (ACD). These formulae work well (±0.5D) in normal eyes. However, these formulae can leads to biased and unpredictable refractive results in eyes that had refractive surgery procedures such as LASIK, PRK, and RK. With a large number of patients undergoing refractive surgery every year, the problem is becoming more severe.
The conventional IOL formulae fail because several inherent assumptions are no longer true in the eye that had refractive surgery. These assumptions are: 1) The corneal refractive power is uniform. 2) The anterior and posterior corneal power has a fixed relationship such that the overall corneal refractive power can be calculated from the anterior keratometry (or topography) using the keratometric index. 3) The position of IOL can be predicted by K with or without additional information such as WTW and ACD.
Relative to the posterior curvature, the anterior curvature becomes flatter after myopic correction and steeper after hyperopic correction with LASIK or PRK. To adapt the conventional IOL formulae to this situation, most surgeons use rigid contact lens over-refraction to calculate an "effective K." However, the accuracy of refraction in cataract patients is poor due to poor vision. Alternatively, one could use a historical method to calculate the effective K from pre-refractive surgery values. However, those measurements are often no longer available. If many years have lapsed, the historical value may no longer accurately reflect the current shape of the cornea.
The axial position of the IOL is determined by the positions of lens zonules and capsule which is in turn related to the corneal curvature (K) in the normal eye. A flatter cornea (lower K) is usually associated with a larger anterior segment, where the lens apparatus is located further back. A more complex model that also uses a separately measured white-to-white corneal diameter may be even more accurate. In post-refractive surgery eyes, however, K is altered and no longer has the normal relationship with the size of the eye. One way to get around this is to enter the pre-refractive surgery K. However, this historical information is not always available. We believe that a better solution would be use an entirely different approach that does not depend on the 3 above assumptions at all. Since OCT can separately measure the corneal anterior and posterior surfaces and AC and lens dimensions, we believe it has the potential of being the basis of a much better IOL calculation formula.
Previously we developed a method to measure both anterior and posterior corneal surface curvatures and obtain more accurate corneal power measurements than conventional keratometry, which only measures the anterior surface. This was the basis of an OCT-based intraocular lens (IOL) formula that showed better results than other formulas for post-myopic LASIK cataract surgery. However, this formula was only on par with the best regression-based formulas in eyes with previous hyperopic LASIK or radial keratectomy (RK), because IOL position prediction error and higher-order corneal aberration limited the accuracy of optical calculations in in these cases. We propose to improve IOL position prediction by using the long-range OCT that can image the entire anterior eye and accurately measure the lens equatorial position. We propose to more accurately determine corneal power in the presence of high aberration by developing ray tracing techniques based on ultrahigh-speed OCT mapping of corneal surfaces. Together, these new methods should improve IOL selection and refractive outcome for all types of eyes. In addition, we will develop a new OCT-based toric IOL formula that takes into account posterior corneal astigmatism, which is ignored in conventional keratometry.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients seeking cataract surgery with implantation of monofocal IOLs (including toric IOLs) but not multifocal or accommodative IOLs.
Key inclusion criteria (2 listed)
- The subjects will be patients seeking cataract surgery with implantation of monofocal IOLs (including toric IOLs) but not multifocal or accommodative IOLs.
- Subjects will have had post-laser vision correction (LVC) such as previous LASIK, PRK, laser sub-epithelial keratectomy (LASEK), epi-LASIK (surface laser ablation under a microkeratome-created epithelial flap) or RK. The post-LVC group will be subdivided into those who have previous hyperopic LVC and those who have previous myopic LVC.
Key exclusion criteria (4 listed)
- Inability to give informed consent.
- Inability to maintain stable fixation for OCT imaging.
- Inability to commit to required visits to complete the study.
- Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery.
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 |
|---|---|---|
| OCT measurementsAlso: Manufacturer/Name OCT Technology 510(K), Optovue/RTVue-CAM Fourier-domain K071250, Bioptigen/Bioptigen Fourier-domain K063343, Zeiss/Visante Time-domain K051789This study is about a new imaging method to study the front part of the eye. This imaging method is called Optical Coherence Tomography (OCT) which provides detailed cross-sectional (layered) views of structures in the eye. The OCT system scans a beam of light across the eye to take a picture. OCT provides a more detailed image than other imaging methods of the eye such as ultrasound, CT scan (computed tomography), and MRI (magnetic resonance imaging). In addition, OCT imaging does not touch the eye. OCT is routinely used in imaging structures in the back of the eye (retina) and cornea. This study uses high-speed FDA approved OCT systemsThe measurements from the OCT systems are used in selecting IOL power. | Device | – |
Primary outcome
IOL power prediction (baseline visit)
Time frame: Study enrollment
Subjects will be assessed at study enrollment, and a prediction of the most suitable IOL power will be made. Predicted IOL power will be measured in Diopters.
IOL power prediction error (post-operative visit)
Time frame: No later than 6-months following cataract surgery.
Subjects will be assessed no later than 6-months following cataract surgery to assess accuracy of IOL power prediction at baseline visit. IOL power error will be measured in Diopters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Derived from this study: PubMed 26459996Wang L, Tang M, Huang D, Weikert MP, Koch DD. Comparison of Newer Intraocular Lens Power Calculation Methods for Eyes after Corneal Refractive Surgery. Ophthalmology. 2015 Dec;122(12):2443-9. doi: 10.1016/j.ophtha.2015.08.037. Epub 2015 Oct 14.
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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.
David Huang, MD, PhD principal investigator
Casey Eye Institute, Oregon Health & Science University
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 Oregon Health and Science University at 1 site in United States.
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 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 12 Feb 2024. 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 United States. 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 Humberto Martinez, COT (503-494-7712, martinhu@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOL power prediction (baseline visit) (time frame: Study enrollment). The study lists 2 primary outcomes in all. 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 NCT00532051, 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 12 Feb 2024.