Status:
COMPLETED
Cost-effectiveness of ISBCS vs. DSBCS
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Bilateral Cataract
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effectiveness and costs of immediately sequential bilateral cataract surgery (ISBCS) compared to delayed sequential bilateral cataract surgery (DSBCS) in o...
Detailed Description
With an estimated number of 180,000 cataract extractions per year in the Netherlands, cataract surgery is one of the most frequently performed types of surgery. The majority of patients suffer from bi...
Eligibility Criteria
Inclusion
- Bilateral cataract
- Indication for bilateral cataract surgery
- Expected uncomplicated surgery
Exclusion
- Inability to comply with study procedures or to complete follow-up / Dutch questionnaires.
- Non-routine cataract surgery
- Cognitive or behavioural conditions that might interfere with surgery
- Cataract surgery with premium IOL implantation
- Conditions that increase the risk of endophthalmitis (e.g. current ocular/adnexal/periocular infections, immune-compromised, iodine allergy)
- Factors that increase the risk of refractive surprise (e.g. axial lengths \<21mm or \>27mm, difference between eyes of \>1.5mm, abnormal keratometry readings, previous refractive surgery)
- Conditions that increase the risk of corneal edema
- Factors that increase the risk of complicated surgery (e.g. previous surgery, trauma, anatomical abnormalities)
- Sight-threatening comorbidity, Glaucoma or IOP \> 24mmHg, Uveitis, Diabetes with diabetic retinopathy and macular edema
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
858 Patients enrolled
Trial Details
Trial ID
NCT03400124
Start Date
September 1 2018
End Date
February 1 2021
Last Update
September 5 2021
Active Locations (1)
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1
Maastricht University Medical Center (MUMC+)
Maastricht, Limburg, Netherlands, 6229 HX