NCT01841957

Brief Summary

To evaluate the safety and efficacy of treating visually significant bilateral cataract with the newer technique of Immediate Simultaneous Bilateral Cataract Surgery (ISBCS) versus the conventional technique of Delayed Sequential Bilateral Cataract Surgery (DSBCS) in a select patient population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 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

Study Start

First participant enrolled

April 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

9 years

First QC Date

April 18, 2013

Last Update Submit

April 20, 2022

Conditions

Bilateral Cataract

Keywords

Bilateral CataractSimultaneous Cataract SurgeryISBCS

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Best uncorrected and best spectacle corrected post-operative visual acuity

    3 weeks

Secondary Outcomes (1)

  • Recovery time and number of post-operative visits

    6 months

Study Arms (2)

ISBCS

EXPERIMENTAL

Immediate Simultaneous Bilateral Cataract Surgery

Procedure: ISBCS

DSBCS

ACTIVE COMPARATOR

Delayed Sequential Bilateral Cataract Surgery

Procedure: DSBCS

Interventions

ISBCSPROCEDURE

same-day cataract surgery

ISBCS
DSBCSPROCEDURE

bilateral surgery delayed by 1-3 weeks amongst eyes

DSBCS

Eligibility Criteria

Age30 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 30-100
  • Candidate for topical anesthesia
  • Signed the informed consents

You may not qualify if:

  • Allergies to medications used in study
  • Cannot have topical anesthesia
  • Unwilling to participate in research trial
  • Have any other significant ocular comorbidities
  • Have known systemic immuno-compromised state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Panhandle Eye Group

Amarillo, Texas, 79106, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 18, 2013

First Posted

April 29, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

April 28, 2022

Record last verified: 2022-04

Locations

US(1)