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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56417

Enrollment

126

Registered

2019-09-25

Start date

2020-07-02

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial cell loss sub-clinical inflammation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The main study parameter is difference in pro-inflammatory cytokine levels - among others MMP9- between patients undergoing a pIOL explantation in combination with a cataract surgery compared to pro-inflammatory cytokine levels of patients only undergoing cataract surgery in aqueous humour.	—

Secondary

Measure	Time frame
The secondary parameter is the correlation between cytokines in aqueous humour and their expression in tears.	—

Countries

Netherlands

Outcome results