NCT03400124

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
858

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2020

Enrollment Period

2.1 years

First QC Date

December 22, 2017

Last Update Submit

September 3, 2021

Conditions

Bilateral Cataract

Outcome Measures

Primary Outcomes (1)

  • Refraction: deviation of 1.0 D from target refraction

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

    Four weeks post-operatively

Secondary Outcomes (15)

  • Refraction: deviation of 0.5 D from target refraction

    Four weeks post-operatively

  • Change in visual acuity

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

  • Complications

    Intraoperatively and up to 4 weeks after second-eye surgery

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

    Baseline and 3 months postoperatively

  • Patient reported outcome measures (PROMs): Catquest

    Baseline and 3 months postoperatively

  • +10 more secondary outcomes

Study Arms (2)

ISBCS

ACTIVE COMPARATOR

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

Procedure: ISBCS

DSBCS

ACTIVE COMPARATOR

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

Interventions

ISBCSPROCEDURE

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

ISBCS
DSBCSPROCEDURE

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.

DSBCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center (MUMC+)

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Publications (2)

  • Spekreijse L, Simons R, Winkens B, van den Biggelaar F, Dirksen C, Bartels M, de Crom R, Goslings O, Joosse M, Kasanardjo J, Lansink P, Ponsioen T, Reus N, Schouten J, Nuijts R. Safety, effectiveness, and cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (BICAT-NL study): a multicentre, non-inferiority, randomised controlled trial. Lancet. 2023 Jun 10;401(10392):1951-1962. doi: 10.1016/S0140-6736(23)00525-1. Epub 2023 May 15.

    PMID: 37201546DERIVED

  • Spekreijse LS, Simons RWP, Winkens B, van den Biggelaar FJHM, Dirksen CD, Nuijts RMMA. Cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (the BICAT-NL study): study design of a prospective multicenter randomised controlled trial. BMC Ophthalmol. 2020 Jun 29;20(1):257. doi: 10.1186/s12886-020-01521-x.

    PMID: 32600295DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Rudy Nuijts, PhD

    Department of Ophthalmology, Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2017

First Posted

January 17, 2018

Study Start

September 1, 2018

Primary Completion

October 1, 2020

Study Completion

February 1, 2021

Last Updated

September 5, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)