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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Humberto Martinez, COT contact

503-494-7712

martinhu@ohsu.edu

Denny Romfh, OD contact

503-494-4351

romfhd@ohsu.edu

United States1 site, 1 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

    Recruiting

Other trials in United States

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.

  1. 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

  2. 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.

  1. First posted19 Sep 2007 (estimated)
  2. Study startApr 2011
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

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)
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

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.

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