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Cost-effectiveness of ISBCS vs. DSBCS

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ClinicalTrials.gov Identifier: NCT03400124
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : February 27, 2020
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

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

Condition or disease Intervention/treatment Phase
Bilateral Cataract Procedure: ISBCS Procedure: DSBCS Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 858 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cost-effectiveness of Immediately Versus Delayed Sequential Bilateral Cataract Surgery (ISBCS vs. DSBCS)
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: ISBCS
The intervention group will undergo cataract surgery of both eyes on the same day (ISBCS)
Procedure: ISBCS
The intervention group will undergo cataract surgery in both eyes on the same day (ISBCS)

Active Comparator: DSBCS
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).
Procedure: DSBCS
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 Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400124


Contacts
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Contact: Lindsay Spekreijse, MD 433875404 ext 0031 lindsay.spekreijse@mumc.nl
Contact: Frank van den Biggelaar, PhD 433877344 ext 0031 f.vandenbiggelaar@mumc.nl

Locations
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Netherlands
Maastricht University Medical Center (MUMC+) Recruiting
Maastricht, Limburg, Netherlands, 6229 HX
Contact: Spekreijse, MD       lindsay.spekreijse@mumc.nl   
Sub-Investigator: L.S. Spekreijse, MD         
Principal Investigator: R.M.M.A. Nuijts, MD, PhD         
Sub-Investigator: F.J.H.M. van den Biggelaar, PhD         
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: Rudy Nuijts, PhD Department of Ophthalmology, Maastricht University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03400124    
Other Study ID Numbers: NL64304.068.17
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases