Cost-effectiveness of immediately versus delayed sequential bilateral cataract surgery (ISBCS vs. DSBCS)
- Conditions
- clouding of the lens in the eyeCataract1001591910015957
- Registration Number
- NL-OMON50196
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 865
- Bilateral cataract with indication for bilateral cataract surgery
- Expected uncomplicated cataract surgery
- Age < 18 years
- Insufficient understanding of the Dutch language to comply with study
procedures and/or complete patient questionnaires
- Inability to complete follow-up or comply with study procedures
- Non-routine cataract surgery (e.g., cataract surgery combined with another
ocular procedure, cataract surgery under general anaesthesia)
- Cognitive or behavioural conditions that might interfere with surgery
- Cataract surgery with premium IOL implantation (i.e., toric IOLs, multifocal
IOLs)
- Conditions that increase the risk of endophthalmitis (Current ocular,
adnexal, or periocular infections (e.g., untreated blepharitis),
Immune-compromised (e.g., systemic corticosteroid use, leukaemia), Iodine
allergy)
- Factors that increase the risk of refractive surprise: (Abnormal axial
lengths (< 21 mm or > 27 mm) or a difference between both eyes of > 1.5 mm,
Abnormal keratometry readings, Previous refractive surgery, Myopia with
posterior staphylomas)
- Conditions that increase the risk of corneal edema (e.g., Fuchs* endothelial
dystrophy)
- Factors that increase the risk of complicated surgery: (Previous ocular
surgery, Previous perforating or blunt eye trauma, Eye, adnexal, or anatomical
abnormalities (including pseudoexfoliation syndrome), Lens luxation or
iridodonesis, Cataract nigrans, posterior polar cataract)
- Sight-threatening comorbidity
- Glaucoma or intraocular pressure of > 24 mmHg
- Uveitis
- Diabetes mellitus with diabetic retinopathy and macular edema.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Proportion of patients with a refractive outcome in the second eye that<br /><br>deviates less than ± 1.0 dioptre from the target refraction (primary outcome). </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Proportion of patients with a refractive outcome in the second eye that<br /><br>deviates less than ± 0.5 dioptre from the target refraction<br /><br>- Corrected and uncorrected distance visual acuity<br /><br>- Complications<br /><br>- Patient reported outcomes (PROMs)<br /><br>- Cost-effectiveness and budget impact</p><br>