Trial Outcomes & Findings for Vault Evaluation After ICL Implantation (NCT NCT06229119)

NCT ID: NCT06229119

Last Updated: 2025-03-04

Results Overview

Difference between the predicted vault at the preoperative visit and the actual vault measured at the 1-month visit

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

1-month

Results posted on

2025-03-04

Participant Flow

Enrollment was expected to be 33 per the protocol, but enrollment proved difficult. 21 subjects were screened, with one screen failure. Twenty subjects started and completed the study.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	ICL Implantation Group ICL implantation Implantable Collamer Lens: The EVO ICL lens is intended to be placed entirely within the posterior chamber directly behind the iris and in front of the anterior capsule of the human crystalline lens. When correctly positioned, the EVO ICL lens functions as a refractive element to optically reduce moderate to high myopia with or without astigmatism.
Overall Study STARTED	20 40
Overall Study COMPLETED	20 40
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vault Evaluation After ICL Implantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ICL Implantation Group n=20 Participants ICL implantation Implantable Collamer Lens: The EVO ICL lens is intended to be placed entirely within the posterior chamber directly behind the iris and in front of the anterior capsule of the human crystalline lens. When correctly positioned, the EVO ICL lens functions as a refractive element to optically reduce moderate to high myopia with or without astigmatism.
Age, Continuous	32.5 years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 1-month

Population: Patients with ICL placed horizontally were included in the analysis.

Difference between the predicted vault at the preoperative visit and the actual vault measured at the 1-month visit

Outcome measures

Outcome measures
Measure	ICL Implantation Group n=30 eyes ICL implantation Implantable Collamer Lens: The EVO ICL lens is intended to be placed entirely within the posterior chamber directly behind the iris and in front of the anterior capsule of the human crystalline lens. When correctly positioned, the EVO ICL lens functions as a refractive element to optically reduce moderate to high myopia with or without astigmatism.
Mean Difference Between Predicted and Actual Central Vault at 1-month After ICL Implantation	0.170 Milimeters Standard Deviation 0.137

Adverse Events

ICL Implantation Group

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

Director of Clinical Research

Carolina Eyecare Physicians, LLC

Phone: 8438813937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place