Cost-effectiveness of ISBCS vs. DSBCS

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Bilateral Cataract

Treatments: Procedure: ISBCS; Procedure: DSBCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03400124

NL64304.068.17

Details and patient eligibility

About

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 order to determine whether ISBCS is an effective and cost-effective alternative to DSBCS.

Full 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 bilateral cataract and while cataract surgery of one eye is effective in restoring functional vision, second-eye surgery leads to further improvement in health-related quality of life.

Currently, 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 cataract surgery of both eyes on the same day, but as separate procedures, known as immediately sequential bilateral cataract surgery (ISBCS).

Potential benefits of ISBCS include less time between surgeries, a faster total recovery period and lower costs. Potential risks, however, are complications of cataract surgery in general, most importantly the risk of endophthalmitis and refractive surprise. In ISBCS, both eyes are at risk at the same time, while in DSBCS both eyes are exposed to these risks consecutively.

Since there is no consensus yet about the role of ISBCS in current regular practice, further investigation of functional and surgical outcomes and cost-effectiveness of ISBCS compared to DSBCS is required. Therefore, the purpose of this study is to evaluate the effectiveness and costs of ISBCS compared to DSBCS, in order to determine whether ISBCS is an effective and cost-effective alternative to DSBCS.

Enrollment: 858 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bilateral cataract
• Indication for bilateral cataract surgery
• Expected uncomplicated surgery

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

858 participants in 2 patient groups

ISBCS

Active Comparator group

Description:

The intervention group will undergo cataract surgery of both eyes on the same day (ISBCS)

Treatment:

Procedure: ISBCS

DSBCS

Active Comparator group

Description:

The usual care / control group will undergo cataract surgery of both eyes on separate days, with a time period of at least two weeks between surgeries (DSBCS).

Treatment:

Procedure: DSBCS