OCT Technology for Keratoconus

Overseen By Denzil Romfh, OD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Retinal diseases, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

258 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if OCT technology (a type of imaging) can enhance the fitting of scleral contact lenses for individuals with specific eye conditions. These conditions include keratoconus (a thinning of the cornea), complications after eye surgeries like LASIK, or other surface issues requiring special contact lenses. The trial compares traditional lens fitting with a new method using OCT to identify which is more effective. Suitable participants need scleral lenses due to the mentioned conditions and must not have other serious eye problems like retinal diseases or glaucoma.

As a Phase 2 trial, this research measures the effectiveness of the new OCT method in an initial, smaller group, offering participants the potential benefit of improved lens fitting.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that OCT technology is safe for optimizing scleral contact lens fittings?

Research has shown that scleral lenses are generally safe for people with various eye conditions. A study on patients with keratoconus, a condition affecting the cornea's shape, confirmed that these lenses are safe and effective over time. Another source stated that scleral lenses are as safe as other approved contact lenses for extended wear.

In children, scleral lenses have also proven safe and effective for treating eye surface diseases and irregularly shaped corneas. Although fitting the lenses can present challenges and minor complications may occur, the risk of serious infections remains low. Overall, scleral lenses are well-tolerated and considered safe for various eye conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of wide-field OCT (optical coherence tomography) for scleral lens fitting because it offers a new way to precisely map the eye's surface. Unlike traditional fitting methods that rely on less detailed imaging, wide-field OCT provides a comprehensive view, allowing for more accurate and personalized lens fitting. This could lead to improved comfort and vision quality for patients using scleral lenses, which are often prescribed for conditions like keratoconus and severe dry eye. By enhancing the fitting process, this technique has the potential to significantly improve patient outcomes and satisfaction compared to current standard practices.

What evidence suggests that OCT technology is effective for optimizing scleral contact lens fittings?

Studies have shown that scleral lenses, evaluated in this trial, can greatly improve vision for individuals with certain eye conditions, such as keratoconus or post-surgery issues. For instance, one study found that scleral lenses improved vision by an average of 3.3 lines on an eye chart compared to regular glasses or contacts. Another study demonstrated that 22% more people achieved 20/20 vision or better with scleral lenses. These lenses also reduce the need for additional eye treatments by about 60%. Overall, scleral lenses effectively provide better vision and comfort for those with specific eye conditions. ^{6 7 8 9 10}

Who Is on the Research Team?

David Huang, MD, PhD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

Inclusion Criteria

Eyes requiring fit for scleral lenses for KCN, post-PK, post-RK, post-LASIK ectasia, or various anterior surface disorders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lens Fitting

Participants undergo scleral lens fitting using both clinically-selected and OCT-selected methods

Varies per participant

Multiple visits for lens fitting and assessment

Follow-up

Participants are monitored for lens fit quality and safety over time

5 years

What Are the Treatments Tested in This Trial?

Interventions

• OCT Technology
• Scleral Lens Fitting

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32941343/

Clinical Outcomes of Scleral Lens Fitting with a Data-driven ... Compared with habitual correction, 22% more eyes achieved 20/20 or better, and 21% more eyes achieved 20/40 or better. There was also a 60% decrease in the need ...

2. cureus.com cureus.com/articles/330222-long-term-effectiveness-of-scleral-lens-treatment-in-the-management-of-keratoconus-a-systematic-review

Long-Term Effectiveness of Scleral Lens Treatment in ... Scleral lenses consistently improved best-corrected visual acuity (BCVA) across studies, with visual gains from baseline logMAR 0.50-0.53 to ...

3. oftalmoloji.org oftalmoloji.org/articles/spectrum-of-scleral-lens-fit-and-patient-compliance-a-single-center-retrospective-study/tjo.galenos.2025.23238

Spectrum of Scleral Lens Fit and Patient Compliance Mean BCVA improved 3.3 lines with scleral lenses compared to spectacle correction in all patients. Subjective complaints associated with scleral ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1367048424000663

and impression-based technology for scleral lens fitting ... Conclusion. In this study, practitioner-reported efficiency of SL fitting was similar between diagnostic, image-based and impression-based methods for patients ...

5. bmcophthalmol.biomedcentral.com bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-025-04155-z

Efficacy of mini-scleral lenses in visual rehabilitation for ... Our study demonstrated that MSDs significantly improved visual outcomes, with 80% of eyes (32 out of 40) achieving a best lens-corrected visual ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7547898/

Safety and Efficacy of Scleral Lenses for Keratoconus - PMC This study affirms the long-term safety and efficacy of scleral contact lens use in patients with keratoconus. This study aimed to evaluate ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/P220007B.pdf

Summary of Safety and Effectiveness Data (SSED) Following the contact lens fitting, symptoms/complaints were ... lens is as safe and effective as other approved extended wear contact lenses.

8. reviewofcontactlenses.com reviewofcontactlenses.com/article/handle-sclerals-with-care

Handle Sclerals With Care A significant concern raised with the surge in scleral lens use is the lack of long-term surveillance on safety data. Even though scleral ...

9. healio.com healio.com/news/optometry/20250224/scleral-lenses-effective-safe-overall-for-pediatric-population

Scleral lenses effective, 'safe overall' for pediatric population Scleral lenses demonstrated safety and efficacy for treating ocular surface disease and irregular cornea/refractive conditions in children, ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1367048415300217

Complications and fitting challenges associated with ... Review of complications and fit challenges associated with scleral contact lenses. There is a low incidence of threatening infectious events reported.