Recruiting

Optical Coherence Tomography

Sponsor:

Oregon Health and Science University

Code:

NCT00532051

Conditions

Cataract

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OCT measurements

Study Details

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.

Conditions

Cataract

Study ID

NCT00532051

Start date

Apr, 2011

Status verified date

Feb, 2024

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

690 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • IOL power prediction (baseline visit) [ Time Frame: Study enrollment ]
  • IOL power prediction error (post-operative visit) [ Time Frame: No later than 6-months following cataract surgery. ]

Central Contacts and Locations

Central contacts

Humberto Martinez, COT

503-494-7712martinhu@ohsu.edu

Denny Romfh, OD

503-494-4351romfhd@ohsu.edu

Locations

Casey Eye Institute, Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Humberto Martinez, COT

503-494-7712martinhu@ohsu.edu

Denny Romfh, OD

503-494-4351romfhd@ohsu.edu

Principal Investigator:

David Huang, MD, PhD

More Information

Sponsor

Oregon Health and Science University

Last update posted

Feb 12, 2024

Last verified

Feb, 2024

Keywords

  • cataract, lasik, laser refractive surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2024-02-12.