Vault Evaluation After ICL Implantation

Phase 4

Completed

Brief Summary: The purpose of this study is to evaluate the lens vault after implantation of an implantable collamer lens (ICL). The ICL is designed to be implanted in front of the eye, without removing the natural lens. Because of this, it is also known as a phakic IOL. The ICL has already been approved by the U.S. Food and Drug Administration (FDA) to treat mid to high degrees of refractive errors such nearsightedness (also called myopia) with or without astigmatism. Once the artificial lens is implanted, a space between the ICL and the crystalline lens is created, which is called vault.

Detailed Description: The ICL will be implanted in both eyes of study subjects. Diagnostic instrumentation will be used to measure the vault between the ICL and the crystalline lens.

Recruitment & Eligibility

Inclusion Criteria

Gender: Males and Females.
Age: 21 to 45 years of age
Willing and able to provide written informed consent for participation in the study
Willing and able to comply with scheduled visits and other study procedures.
Scheduled to undergo ICL implantation in both eyes within 1 to 30 days between surgeries.
Subjects who require an ICL power in the range of -3.00 to -15.00 D.

Exclusion Criteria

Patients who do not qualify for an ICL according to the Direction For Use (DFU)
Unstable or worsening myopia
Use of any systemic or topical drug known to interfere with visual performance.
Irregular astigmatism.
History of retinal detachment.
Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
Pigment dispersion
Previous intraocular surgery.
Previous refractive surgery.
Previous keratoplasty
Pupil abnormalities
Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.

Arm && Interventions

Group	Intervention	Description
ICL	Implantable Collamer Lens	ICL implantation

Primary Outcome Measures

Name	Time	Method
Mean Difference Between Predicted and Actual Central Vault at 1-month After ICL Implantation	1-month	Difference between the predicted vault at the preoperative visit and the actual vault measured at the 1-month visit

Secondary Outcome Measures