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OpenTrials
Completed

NCT Number: NCT03400124

Cost-effectiveness of ISBCS vs. DSBCS

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.

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Key information

Conditions

Bilateral Cataract Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center (MUMC+)

Maastricht, Limburg, 6229 HX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ISBCS

Procedure

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

DSBCS

Procedure

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

Primary outcomes

  1. Refraction: deviation of 1.0 D from target refraction

    Time frame: Four weeks post-operatively

    Proportion of patients in both treatment groups with a postoperative refraction in the second eye that deviates 1.0 diopters (D) from target refraction

Secondary outcomes

  1. Refraction: deviation of 0.5 D from target refraction

    Time frame: Four weeks post-operatively

    Proportion of patients in both treatment groups with a postoperative refraction in the second eye that deviates 0.5 diopters (D) from target refraction

  2. Change in visual acuity

    Time frame: Baseline, 1 week after first-eye surgery and 4 weeks after second-eye surgery

    Visual acuity will be measured by ETDRS letter charts

  3. Complications

    Time frame: Intraoperatively and up to 4 weeks after second-eye surgery

    The incidence of intraoperative and postoperative complications

  4. Patient reported outcome measures (PROMs): NEI VFQ-25

    Time frame: Baseline and 3 months postoperatively

    Patient satisfaction and vision-specific quality of life as measured by National Eye Institute Visual Function Questionnaire (NEI VFQ-25).

  5. Patient reported outcome measures (PROMs): Catquest

    Time frame: Baseline and 3 months postoperatively

    Patient satisfaction and vision-specific quality of life as measured by Catquest questionnaire.

  6. Patient reported outcome measures (PROMs): HUI3

    Time frame: Baseline, 1,4 weeks and 3 months postoperatively

    Health-related quality of life as measured by HUI3 (Health Utility Index Mark 3) questionnaire.

  7. Patient reported outcome measures (PROMs): EQ-5D-5L

    Time frame: Baseline, 1,4 weeks and 3 months postoperatively

    Health-related quality of life as measured by EQ-5D-5L questionnaire.

  8. Quality Adjusted Life Years (QALYs)

    Time frame: Baseline until 3 months postoperatively

    Calculated based on generic health-related quality of life, using the EQ-5D-5L and HUI-3 questionnaires

  9. Costs per patient

    Time frame: Baseline until 3 months postoperatively

    Cost per patient, including valuation of resource use by using the Dutch guidelines for cost-analyses or cost prices provided by the medical center.

  10. Incremental cost-effectiveness ratios (ICERs): QALY

    Time frame: Baseline until 3 months postoperatively

    Evaluation of cost-effectiveness by using calculated costs per quality-adjusted life years (QALYs)

  11. Incremental cost-effectiveness ratios (ICERs): Target refraction

    Time frame: Baseline until 3 months postoperatively

    Calculated costs per patient with a postoperative refraction within 1.0 D of target refraction

  12. Incremental cost-effectiveness ratios (ICERs): NEI VFQ-25

    Time frame: Baseline until 3 months postoperatively

    Calculated costs per clinically improved patient on the NEI VFQ-25 questionnaire

  13. Incremental cost-effectiveness ratios (ICERs): Catquest

    Time frame: Baseline until 3 months postoperatively

    Calculated costs per clinically improved patient on the Catquest questionnaire

  14. Incremental cost-effectiveness ratios (ICERs): Visual acuity

    Time frame: Baseline until 3 months postoperatively

    Calculated costs per patient with clinical improvement in (un)corrected distance visual acuity

  15. Budget impact

    Time frame: Baseline until 3 months postoperatively

    Reported as a difference in costs. Different scenario's will be compared to investigate the impact of various levels of implementation (e.g. 25%, 50%, 75% of eligible patients).

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

Cost-effectiveness of Immediately Versus Delayed Sequential Bilateral Cataract Surgery (ISBCS vs. DSBCS)

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jan 17, 2018
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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