Intraocular Lens Power Calculation After Laser Refractive Surgery Based on Optical Coherence Tomography (OCT IOL)
|ClinicalTrials.gov Identifier: NCT00532051|
Recruitment Status : Unknown
Verified April 2015 by David Huang, Oregon Health and Science University.
Recruitment status was: Recruiting
First Posted : September 19, 2007
Last Update Posted : April 23, 2015
The long-term goal of this project is to utilize newly available 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.
|Condition or disease||Intervention/treatment|
|Cataract||Device: OCT measurements|
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 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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Guiding the Treatment of Anterior Eye Diseases With Optical Coherence Tomography|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2016|
Device: OCT measurements
- Manufacturer/Name OCT Technology 510(K)
- Optovue/RTVue-CAM Fourier-domain K071250
- Bioptigen/Bioptigen Fourier-domain K063343
- Zeiss/Visante Time-domain K051789
- IOL power prediction error [ Time Frame: Pre-surgery and post-operatively at 1 month ]Subjects will be assessed both preoperatively and at one month post cataract surgery
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532051
|Contact: Janice Ladwigfirstname.lastname@example.org|
|Contact: Denny Romfhemail@example.com|
|United States, Oregon|
|Casey Eye Institute, Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97229|
|Contact: Janice Ladwig 503-494-8024 firstname.lastname@example.org|
|Contact: Denny Romfh 503-494-4651 email@example.com|
|Principal Investigator:||David Huang, MD, PhD||Casey Eye Institute, Oregon Health & Science University|