NCT04247152

Brief Summary

Examination of the accuracy of toric predictive power in patients with 1.5 diopters of astigmatism or less.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 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

July 22, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
Last Updated

April 20, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

January 24, 2020

Last Update Submit

April 16, 2020

Conditions

Cataract Surgery

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients requiring Astigmatism Correction

    Proportion of patients requiring astigmatism correction, i.e., having need for astigmatism correction of greater than or equal to 0.5 D during cataract surgery, when measured by preoperative keratometry vs intraoperative aberrometry.

    up to 3 months

Secondary Outcomes (2)

  • Patients with Postoperative residual astigmatism 0.5 to 1.0 diopter

    up to 3 months

  • Patients with Postoperative residual astigmatism 1.0 to 1.5 diopter

    up to 3 months

Study Arms (1)

Intraoperative Aberrometry vs Preoperative Biometry

OTHER

Retrospective view of existing chart data.

Other: Intraoperative Aberrometry vs preoperative biometry

Interventions

Intraoperative Aberrometry vs preoperative biometryOTHER

Hypothesis: Intraoperative aberrometry measures lower levels of astigmatism more accurately than preoperative biometry in patients undergoing cataract surgery.

Intraoperative Aberrometry vs Preoperative Biometry

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent conventional (non-femtosecond) cataract surgery and whose "data to be collected" are accessible and available from the ORA database.
  • Patients whose medical records show they did not exhibit any significant ocular morbidity that would be expected to influence outcome measures.

You may not qualify if:

  • Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their visual outcome or ability to be refracted after.
  • Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.)
  • Patients with previous refractive surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 29, 2020

Study Start

July 22, 2019

Primary Completion

September 25, 2019

Study Completion

September 25, 2019

Last Updated

April 20, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)