To evaluate the effectiveness and costs of immediately sequential bilateral cataract surgery (ISBCS) compared to delayed sequential bilateral cataract surgery (DSBCS; usual care) in order to determine whether ISBCS is an effective and cost-effective…
ID
Source
Brief title
Condition
- Eye disorders
- Eye therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of patients with a refractive outcome in the second eye that
deviates less than ± 1.0 dioptre from the target refraction (primary outcome).
Secondary outcome
- Proportion of patients with a refractive outcome in the second eye that
deviates less than ± 0.5 dioptre from the target refraction
- Corrected and uncorrected distance visual acuity
- Complications
- Patient reported outcomes (PROMs)
- Cost-effectiveness and budget impact
Background summary
With an estimated number of cataract extractions of 180,000 per year in the
Netherlands, cataract surgery is one of the most frequently performed types of
surgery. The majority of patients suffer from bilateral cataract and while
cataract surgery of only one eye is effective in restoring functional vision,
second-eye surgery leads to further improvements in health-related quality of
life, and is cost-effective. At present, most patients undergo cataract surgery
in both eyes on separate days as recommended in national guidelines, referred
to as delayed sequential bilateral cataract surgery (DSBCS). An alternative
procedure involves operating both eyes on the same day, but as separate
procedures, known as immediately sequential bilateral cataract surgery (ISBCS).
Our hypothesis is that the clinical effectiveness and quality of life of ISBCS
and DSBCS are equivalent, while ISBCS leads to lower costs and better patient
satisfaction.
Study objective
To evaluate the effectiveness and costs of immediately sequential bilateral
cataract surgery (ISBCS) compared to delayed sequential bilateral cataract
surgery (DSBCS; usual care) in order to determine whether ISBCS is an effective
and cost-effective alternative to DSBCS.
Study design
Multicentre randomized clinical trial.
Intervention
Intervention: Bilateral phacoemulsification cataract surgery during a single
operating session by a single surgeon (ISBCS). Surgical procedures will be
strictly separated with regard to aseptic procedures.
Usual care / comparison: Bilateral phacoemulsification cataract surgery during
two operating sessions with a minimum of two weeks apart (DSBCS).
Study burden and risks
Potential benefits of participating in this study (for patients allocated to
ISBCS) include less time between surgeries, fewer hospital visits, a faster
total recovery period due to simultaneous postoperative care (eye drops) in
both eyes and less use of homecare. Potential risks associated with
participation are the possible complications of cataract surgery in general,
most importantly the very rare but severe risk of endophthalmitis (ocular
infection) and the risk of refractive surprise (a significant deviation from
the predicted refraction). The risk on facing one of these complications is
similar for both eyes, regardless of the time of surgery. The main difference
during this study is that in ISBCS both eyes are at risk at the same time,
while in DSBCS both eyes are exposed to these risks consecutively. Compared to
usual care, the extra burden for all patients participating in this study is
filling in questionnaires four times during the study, which will take 10 till
30 minutes per time (depending on follow-up time point).
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Bilateral cataract with indication for bilateral cataract surgery
- Expected uncomplicated cataract surgery
Exclusion criteria
- 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03400124 |
| CCMO | NL64304.068.17 |