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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 : April 11, 2018
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University

Brief 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 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

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Guiding the Treatment of Anterior Eye Diseases With Optical Coherence Tomography
Study Start Date : April 2011
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Care
U.S. FDA Resources


Intervention Details:
    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


Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients seeking cataract surgery with implantation of monofocal IOLs (including toric IOLs) but not multifocal or accommodative IOLs.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
Contact: Denzil Romfh, OD 503-494-4351 romfhd@ohsu.edu
Contact: Omkar Thaware, B Optom, MSVS 503-494-7398 thaware@ohsu.edu

Locations
United States, Oregon
Casey Eye Institute, Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97229
Contact: Denzil Romfh, OD    503-494-4351    romfhd@ohsu.edu   
Contact: Omkar Thaware, B Optom, MSVS    503-494-7398    thaware@ohsu.edu   
Principal Investigator: David Huang, MD, PhD         
Sub-Investigator: Winston Chamberlain, MD, PhD         
Sub-Investigator: Afshan Nanji, MD         
Sub-Investigator: John Clements, MD         
Sub-Investigator: Lorinna Lombardi, MD         
Sub-Investigator: Seema Gupta, MD         
Sub-Investigator: Ellen Davis, MD         
Sub-Investigator: Maolong Tang, PhD         
Sub-Investigator: Yan Li, PhD         
Sub-Investigator: Xinbo Zhang, PhD         
Sponsors and Collaborators
Oregon Health and Science University
National Eye Institute (NEI)
Investigators
Principal Investigator: David Huang, MD, PhD Casey Eye Institute, Oregon Health & Science University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Huang, : David Huang, MD, PhD, Professor of Ophthalmology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00532051     History of Changes
Other Study ID Numbers: OHSU IRB #00006612-IOL
7R01EY018184-04 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2007    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Keywords provided by David Huang, Oregon Health and Science University:
cataract, lasik, laser refractive surgery

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases