Comparing vision outcomes of two types of intraocular lenses
Anterior Chamber Versus Scleral Fixated Intraocular Lens: Long-term Vision and Safety Outcomes
This study is testing which type of eye lens, either the anterior chamber or scleral-fixated lens, gives better long-term vision results for patients who need lens implantation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 16 Years to 99 Years |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04072978 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the long-term vision outcomes, safety, and stability of anterior chamber intraocular lenses (AC IOLs) versus scleral-fixated intraocular lenses (SF IOLs). Patients undergoing implantation of either type of lens will be evaluated using various imaging techniques, including specular microscopy and optical coherence tomography (OCT), at multiple follow-up points. The study will not alter the management plan for participants, and data will be collected to assess the effectiveness of each lens type over time.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing AC IOL or SF IOL implantation for conditions such as aphakia or lens dislocation.
Not a fit: Patients who have had a corneal transplant prior to secondary IOL implantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into which type of intraocular lens offers better long-term vision and safety for patients.
How similar studies have performed: Other studies have explored similar comparisons of intraocular lenses, indicating potential for meaningful insights, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who are undergoing AC IOL or SF IOL implantation for any reason (including but not limited to aphakia, posterior capsular rupture, primary or secondary lens dislocation/ subluxation or IOL exchange). 2. Patients on whom imaging (specular microscopy, biometry and OCT) can be performed without delaying their treatment (i.e. based on availability of operator). 3. Decision makers able to provide informed consent. Exclusion Criteria: 1. Inability to obtain adequate imaging, in the form of specular microscopy and OCT data at baseline. 2. Patients unable to attend follow-up visits. 3. Patients who have had a corneal transplant prior to secondary IOL implantation.
Where this trial is running
Toronto, Ontario
- Sunnybrook Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Peter Kertes, MD — Sunnybrook Hospital
- Study coordinator: Cindy Rutz
- Email: cindy.rutz@sunnybrook.ca
- Phone: 416 480 5091
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.