Molecular background of endothelial cell loss in patients with phakic intraocular lenses (MoBack-ECL): a tear and aqueous humour analysis study

Recruiting

• Conditions: Endothelial cell loss; sub-clinical inflammation; 10002693

• Registration Number: NL-OMON56417
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 126

Inclusion Criteria

Age over 18 ,
Cataract in one or both eyes, or indication for phakic intra-ocular lens
explantation (Artisan or Artiflex lenses)
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 (e.g., cataract surgery combined with another
ocular procedure - other than pIOL explantation -, cataract surgery under
general anaesthe-sia)
• Cognitive or behavioral conditions that might interfere with surgery
• Patients with ocular comorbidities such as: diabetes with vision threatening
diabetic retinopathy or diabetic macular edema, glaucoma (or IOP >24 mmHg),
keratitis, keratoconus, keratopathy, corneal dystrophy, and uveitis.
• 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:
o Previous ocular surgery (for the control group)
o Previous perforating or blunt eye trauma
o Eye, adnexal, or anatomical abnormalities (including pseudoexfoliation
syn-drome)
o Lens luxation or iridodonesis
o Cataract nigrans, posterior polar cataract

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is difference in pro-inflammatory cytokine levels -<br /><br>among others MMP9- between patients undergoing a pIOL explantation in<br /><br>combination with a cataract surgery compared to pro-inflammatory cytokine<br /><br>levels of patients only undergoing cataract surgery in aqueous humour. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary parameter is the correlation between cytokines in aqueous humour<br /><br>and their expression in tears.</p><br>