Trial Outcomes & Findings for Femtosecond Laser Assisted Keratotomies for the Management of Corneal Astigmatism (NCT NCT04676451)

Results Overview

Keratometric Correction index is the ratio of surgically induced astigmatism to target induced astigmatism. A correction index of 1 suggests that the actual surgically induced astigmatism, as measured by pre- vs- post-op reflectance keratometry, perfectly matched the target (anticipated) induced astigmatism. Correction indices below 1 suggest an under-correction while values above 1 suggest an over-correction.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

94 participants

Primary outcome timeframe

1 month

Results posted on

2025-05-13

Participant Flow

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Eyes Eyes that completed the study
Overall Study STARTED	94 188
Overall Study COMPLETED	69 95
Overall Study NOT COMPLETED	25 93

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants Who Completed the Study n=69 Participants Ages of all participants
Age, Categorical <=18 years	0 Participants n=69 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=69 Participants
Age, Categorical >=65 years	57 Participants n=69 Participants
Age, Continuous	73.3734 years n=69 Participants
Region of Enrollment United States	69 participants n=69 Participants

PRIMARY outcome

Timeframe: 1 month

Population: patients underwent cataract extraction with AKs and insertion of a non-toric intraocular lens.

Keratometric Correction index is the ratio of surgically induced astigmatism to target induced astigmatism. A correction index of 1 suggests that the actual surgically induced astigmatism, as measured by pre- vs- post-op reflectance keratometry, perfectly matched the target (anticipated) induced astigmatism. Correction indices below 1 suggest an under-correction while values above 1 suggest an over-correction.

Outcome measures

Outcome measures
Measure	Astigmatic Eyes n=95 eyes Eyes with greater than 0.5 D of against-the-rule (ATR) or 1.0 D of with-the-rule (WTR) or oblique (OBL) astigmatism were treated in accordance with the nomogram.
Keratometric Correction Index	0.51 index Interval 0.04 to 3.45

PRIMARY outcome

Timeframe: 1 month

Refractive Correction index is the ratio of surgically induced astigmatism to net effective astigmatism. A correction index of 1 suggests that the actual surgically induced astigmatism, as measured by pre- vs- post-op manifest refraction, perfectly matched the effective astigmatism as estimated by the nomogram. Correction indices below 1 suggest an under-correction while values above 1 suggest an over-correction.

Outcome measures

Outcome measures
Measure	Astigmatic Eyes n=95 eyes Eyes with greater than 0.5 D of against-the-rule (ATR) or 1.0 D of with-the-rule (WTR) or oblique (OBL) astigmatism were treated in accordance with the nomogram.
Refractive Correction Index	0.91 index Interval 0.0 to 5.32

Adverse Events

Femto-AK Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amy Longenecker

Penn State Hershey Medical Center

Phone: 717-531-1513

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place