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Patient Reported Visual Satisfaction Following Same Day or Delayed Bilateral Cataract Surgery

NCT05069753 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-10-21

No results posted yet for this study

Summary

Cataract is currently the leading cause of visual impairment worldwide with age being the most common cause of lenticular opacification. As cataract surgery is the most commonly performed elective surgery worldwide, forecasts of an increasing number of elderly individuals make it clear that efficient and evidence based models for managing cataract in the future need to be implemented to manage the broadening gap between intervention and available resources.

Bilateral cataract is currently treated using same day separate surgical procedures (immediate sequential bilateral cataract surgery (ISBCS) or on separate days (delayed sequential bilateral cataract surgery (DSBCS). Whether one approach is more ideal than the other is an ongoing debate. There is, however, a clear advantage of same day surgery on resource management.

The primary purpose of this clinical study is to measure the patient reported satisfaction regarding vision in a group of 300 participants following either same day or delayed bilateral cataract surgery.

Conditions

  • Bilateral Cataract
  • Charles Bonnet Syndrome

Interventions

PROCEDURE

Immediate sequential bilateral cataract surgery (ISBCS)

Surgery on both eyes will be performed on the same day as separate procedures: Once surgery on the first eye is completed, a new sterile procedure on the second eye will commence.

PROCEDURE

Delayed sequential bilateral cataract surgery (DSBCS)

The group will undergo bilateral cataract surgery on two separate days with a time period of one week between the two procedures.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Amardeep Singh, MD, PhD · Dpt. of Ophthalmology, Rigshospitalet-Glostrup; University of Copenhagen

  • Mads Assenholt Nielsen · Dpt. of Ophthalmology, Rigshospitalet-Glostrup; University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05069753 on ClinicalTrials.gov