Clinical trial NCT03021707: Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction
Official title: Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error - Myopia Severe
Refractive Error - Myopia Simple
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-01-16
Enrollment: 7
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to evaluate the initial safety of the UV-FS laser in humans.


Eligibility criteria: Inclusion Criteria:

* Photopic distance visual acuity worse than best corrected visual acuity (BCVA) 20/400 in the study eye;
* Myopia with manifest refraction spherical equivalent (MRSE) of - 1.50 diopter (D) or higher in the study eye;
* Able to comprehend and provide documented informed consent;
* Willing and able to comply with schedule for follow-up visits;
* Minimum required endothelial cell density (ECD) in study eye as outlined in the protocol;
* Presence of natural lens in study eye;
* A treatment simulation with spectacles or contact lenses on the study eye does not negatively impact participant's daily activities;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Pregnant or nursing;
* Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study as clinically assessed by the Investigator;
* Active implanted device, including but not limited to, heart pacemaker or defibrillator, for which laser use may be a contraindication;
* Current use of medications with known ocular side effects;
* Predicted residual stromal bed thickness \<300 micrometers (μm) in study eye
* Ocular conditions in the study eye;
* Previous ocular surgery in the study eye that resulted in corneal distortions within the treatment zone;
* Residual, recurrent or active ocular disease that may impact study outcomes;
* Previous or current diagnosis of dry eye;
* Known allergic reaction to medications expected to be used preoperatively, during laser refractive surgery, and for postoperative care;
* Pre-existing corneal opacities in study eye;
* Contact lens worn in study eye and not removed prior to study testing affected by wear per timeframe specified in the protocol;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Presence of optical treatment zone corneal haze
timeFrame: Up to Month 6 (post-operative)
measure: Mean change from screening in presence of disruption in the integrity of retinal layers in the macula
timeFrame: Screening, Up to Month 6 (post-operative)
measure: Mean percentage change in average endothelial cell density (ECD) from screening to each visit post procedure
timeFrame: Screening, Up to Month 6 (post-operative)
measure: Mean percentage change in lens opacification from screening to each visit post procedure
timeFrame: Screening, Up to Month 6 (post-operative)
measure: Mean percentage change in foveal thickness from screening to each visit post procedure
timeFrame: Screening, Up to Month 6 (post-operative)
Secondary outcomes:
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Alcon Investigative Site
state: South Dakota
city: Houston
country: United States
facility: Alcon Investigative Site
state: Texas
city: Dublin
country: Ireland
facility: Alcon Investigative Site
city: Singapore
country: Singapore
facility: Alcon Investigative Site
Study officials:
affiliation: Alcon Research
name: Clinical Manager, Surgical
role: STUDY_DIRECTOR
References: