Analyzing tear and aqueous humor in patients with phakic intraocular lenses
Molecular Background of Endothelial Cell Loss in Patients With Phakic Intraocular Lenses (MoBack-ECL): a Tear and Aqueous Humour Analysis Study
This study is trying to understand why some patients with phakic intraocular lenses lose important eye cells by looking at their tears and eye fluid to see if inflammation or other factors are involved.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT04174924 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the molecular mechanisms behind endothelial cell loss in patients who have undergone phakic intraocular lens (pIOL) implantation. It aims to understand how the aqueous flow in the anterior chamber may be disturbed and whether chronic inflammation contributes to this cell loss. By analyzing tear and aqueous humor samples, the study seeks to identify potential risk factors and underlying causes of endothelial cell degradation in these patients. The findings could provide insights into improving patient outcomes following pIOL procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have cataracts or require pIOL explantation.
Not a fit: Patients with significant ocular comorbidities or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for patients with phakic intraocular lenses, potentially reducing endothelial cell loss and improving long-term eye health.
How similar studies have performed: While there is ongoing research into the effects of pIOLs, this specific approach focusing on molecular analysis of tears and aqueous humor is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age over 18 * Cataract in one or both eyes, or indication for pIOL explantation * Informed and having given informed consent. Exclusion Criteria: * Insufficient understanding of the Dutch language to comply with study procedures * Inability to complete follow-up or comply with study procedures * Non-routine cataract surgery * Cognitive or behavioral conditions that might interfere with surgery * Patients with ocular comorbidities such as * Women who are pregnant or nursing their child * Immune-compromised patients (e.g., systemic corticosteroid use, leukaemia) * Factors that increase the risk of complicated surgery
Where this trial is running
Maastricht, Limburg
- Maastricht University Medical Centre — Maastricht, Limburg, Netherlands (Recruiting)
Study contacts
- Study coordinator: Christian Bertens
- Email: christian.bertens@mumc.nl
- Phone: +31 (0)43 388 1847
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.