Evaluation of the Safety & Efficacy of the Laser Scleral Microporation Procedure to Restore Visual Function and Range of Accommodation

ACE Vision Group, Inc.2 sites in 1 country11 target enrollmentApril 23, 2019

ConditionsPresbyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Presbyopia
Sponsor: ACE Vision Group, Inc.
Enrollment: 11
Locations: 2
Primary Endpoint: Binocular Uncorrected Near Visual Acuity (UNVA) @ 40cm
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A new minimally invasive procedure for treating presbyopia is being evaluated to determine if there is improvement in near and intermediate vision after treatment.

Detailed Description

This is a prospective, controlled, single-center clinical study to evaluate the safety and efficacy of the Laser Scleral Microporation Procedure. Laser Scleral Microporation Procedure is a treatment to restore visual and accommodative function in presbyopic patients. The subjects are bilaterally treated with the Laser Scleral Microporation procedure.

Registry

clinicaltrials.gov

Start Date

April 23, 2019

End Date

December 31, 2019

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

ACE Vision Group, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing and able to understand and sign an informed consent;
•Willing and able to attend postoperative examinations per protocol schedule;
•45 years of age or greater, of either gender or any race;
•Less than (\<) 1.00D of astigmatism in each eye, measured in their manifest refraction;
•Mean refractive spherical equivalent refraction (MRSE) of +/- 0.50D for distance vision; Note: Subjects who meet this criterion as a result of prior laser refractive surgery (LASIK, LASEK or PRK) may qualify; however, the subject must have had the LVC procedure performed at least 12 months prior to the Laser Scleral Microporation procedure and be stable.
•Uncorrected distance visual acuity (UDVA) is better than or equal to 20/40 (logMAR 0.30) in each eye, and a Corrected Distance Visual Acuity (CDVA) is better than or equal to 20/25 (logMAR 0.10) in each eye;
•Demonstrate Stereopsis of 100 seconds of arc or better using a Randot stereoscopic fly test and reading correction;
•In good ocular health with the exception of presbyopia;
•Presbyopia as demonstrated by:
•Currently wearing reading glasses and/or bifocals with an ADD of +1.50D or more at 40 cm in each eye; and

Exclusion Criteria

•Self-reported current pregnancy or breast-feeding, or plans to become pregnant during the entire study period;
•History of ocular trauma or prior ocular surgery, or expected to require retinal laser treatment or other ocular surgical intervention;
•Presence of ocular pathology other than cataract such as:
•Amblyopia or strabismus
•Corneal abnormalities or disease
•Dry Eye, presenting with corneal staining15
•Pupil abnormalities (e.g., corectopia, Adie's)
•Capsule or zonular abnormalities
•Intraocular inflammation
•Retinal disease or pathology

Outcomes

Primary Outcomes

Binocular Uncorrected Near Visual Acuity (UNVA) @ 40cm

Time Frame: 12 months postoperative

Binocular UNVA is measured with ETDRS charts placed in 40cm distance. This assessment is performed under photopic lighting conditions.

Secondary Outcomes

Patient Self-Reporting Questionnaire 2(3 Day, 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative)
Monocular & Binocular Distance Corrected Near Visual Acuity (DCNVA) @ 40cm(1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative)
Patient Self-Reporting Questionnaire 1(1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative)
Monocular & Binocular Uncorrected Near Visual Acuity (UNVA) @ 40cm(1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative)
Manifest Refraction(1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative)
Monocular & Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) @ 60cm(1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative)
iReST reading test(1 week; 1 month; 3 months; 6 months; 12 months & 24 months postoperative)
Stereoacuity(1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative)
Monocular & Binocular Uncorrected Intermediate Visual Acuity (UIVA) @ 60cm(1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative)
Monocular & Binocular Best Corrected Distance Visual Acuity (CDVA) @ 4m(1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative)
Determination of reading prescription(1 week; 1 month; 3 months; 6 months ; 12 months; 18 months & 24 months postoperative)
Auto-Keratometry(1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative)
Axial Length Measurement(1 month; 12 months & 24 months postoperative)
Monocular & Binocular Uncorrected Distance Visual Acuity (UDVA) @ 4m(1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative)
Accommodative Amplitude using binocular & monocular minus lens to blur(1 week; 1 month; 3 months; 6 months; 12 months & 24 months postoperative)
Contrast Sensitivity(1 month; 12 months & 24 months postoperative)
Cycloplegic refraction(1 month; 12 months & 24 months postoperative)
Wavefront Aberrometry(1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative)
Corneal Topography(1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative)
Speedy-i Accommodation Testing(1 week; 1 month; 3 months; 6 months; 12 months & 24 months postoperative)
Pupillometry(1 day, 3 day, 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative)
Dilated Fundus exam(1 month; 12 months & 24 months postoperative)
Slit Lamp Examination(1 day, 3 days, 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative)
Intraocular Pressure Measurement(1 day, 3 days, 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative)