Intraocular Lens Power Calculation After Laser Refractive Surgery Based on Optical Coherence Tomography (OCT IOL)
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|ClinicalTrials.gov Identifier: NCT00532051|
Recruitment Status : Recruiting
First Posted : September 19, 2007
Last Update Posted : September 22, 2022
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.
|Condition or disease||Intervention/treatment|
|Cataract||Device: OCT measurements|
|Study Type :||Observational|
|Estimated Enrollment :||690 participants|
|Official Title:||Guiding the Treatment of Anterior Eye Diseases With Optical Coherence Tomography|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||July 2025|
- 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 systemsThe measurements from the OCT systems are used in selecting IOL power.Other Names:
- 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 (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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532051
|Contact: Humberto Martinez, COTfirstname.lastname@example.org|
|Contact: Denny Romfh, ODemail@example.com|
|United States, Oregon|
|Casey Eye Institute, Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Humberto Martinez, COT 503-494-7712 firstname.lastname@example.org|
|Contact: Denny Romfh, OD 503-494-4351 email@example.com|
|Principal Investigator: David Huang, MD, PhD|
|Sub-Investigator: Winston Chamberlain, MD, PhD|
|Sub-Investigator: Afshan Nanji, MD|
|Sub-Investigator: Seema Gupta, MD|
|Sub-Investigator: Ellen Davis, MD|
|Sub-Investigator: Yan Li, PhD|
|Sub-Investigator: Richard Stutzman, MD|
|Principal Investigator:||David Huang, MD, PhD||Casey Eye Institute, Oregon Health & Science University|