NCT06192901

Brief Summary

Subjects who had a bilateral age-related cataract surgery with the IOLs AT ELANA 841P and AT LISA tri 839MP will be contacted and invited to attend a postoperative visit more than one year after the surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

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

September 12, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

September 18, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

September 1, 2023

Enrollment Period

4 days

First QC Date

September 12, 2023

Last Update Submit

December 20, 2023

Conditions

Senile Cataract

Outcome Measures

Primary Outcomes (2)

  • Monocular Corrected Distance Visual Acuity (CDVA)

    12 to 24 months after cataract surgery

  • Slit Lamp Examination

    12 to 24 months after cataract surgery

Study Arms (2)

Study eye AT ELANA 841P

Subjects who underwent bilateral cataract surgery with the implantation of the IOL AT ELANA 841P in the first eye.

Study eye AT LISA 839MP

Subjects who underwent bilateral cataract surgery with the implantation of the IOL AT LISA tri 839MP in the second eye.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Up to 20 eyes in 10 adult subjects who underwent bilateral cataract surgery with the implantation of the IOL AT ELANA 841P in the first eye and AT LISA tri 839MP in the second eye.

You may qualify if:

  • Adult patient of any gender;
  • Patients who had an uncomplicated (no intra-operative complication) age-related cataract surgery
  • Currently implanted with an IOL model AT ELANA 841P into the capsular bag in one eye and with the IOL model AT LISA tri 839MP into the capsular bag of the other eye.
  • The postoperative visit was scheduled to be conducted more than one year after the second eye surgery.
  • Given written informed consent by patient.

You may not qualify if:

  • Patients unable to meet the limitations of the protocol or likely of non-cooperation during the study
  • Patient whose freedom is impaired by administrative or legal order
  • Concurrent participation in another drug or device investigation that could confound the outcome of this investigation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Quesada

San Salvador, El Salvador

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2023

First Posted

January 5, 2024

Study Start

September 18, 2023

Primary Completion

September 22, 2023

Study Completion

September 22, 2023

Last Updated

January 5, 2024

Record last verified: 2023-09

Locations

EL(1)