Safety & Efficacy of the Laser Scleral Microporation Procedure (Philippines)

NCT04151550 | Completed

• 1 other identifier: AVG-PHIL-2019-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Presbyopia

Keywords

Presbyopia; Sclera; Laser Scleral Microporation

Outcome Measures

Primary Outcomes (1)

• Binocular Distance Corrected Near Visual Acuity (DCNVA) @40cm

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

  12 months postoperative

Secondary Outcomes (19)

• Autorefraction

  1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative

• Monocular Uncorrected Distance Visual Acuity (UDVA) @4m

  1 day; 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative

• Binocular Uncorrected Distance Visual Acuity (UDVA) @4m

  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 Uncorrected Near Visual Acuity (UNVA) @40cm

  1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative

Study Arms (1)

AVG LSM Procedure

OTHER

Ace Vision Group LSM procedure performed on both eyes.

Device: Bilateral Laser Scleral Microporation procedure

Interventions

Bilateral Laser Scleral Microporation procedure DEVICE

Device: Laser Scleral Microporation Partial depth scleral microporations with an Er:YAG laser in a predetermined pattern.

AVG LSM Procedure

Eligibility Criteria

• Age: 48 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to understand and sign an informed consent;
• Willing and able to attend postoperative examinations per protocol schedule;
• years of age or greater, of either gender or any race;
• Less than (\<) 1.00D of astigmatism in each eye, measured by manifest refraction;
• Mean Refractive Spherical Equivalent (MRSE) of less than or equal to 0.50D for distance vision;
• 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 Stereo Fly test with near 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 40cm in each eye; and
• Reduced near visual acuity at 40cm when corrected for distance (DCNVA) of 20/50 (logMAR 0.40) or worse in each eye;
• Intraocular pressure (IOP) ≥ 11mmHg and ≤ 30 mmHg in each eye without IOP-lowering medication;
• Less than or equal to (≤) 0.50D difference between the manifest refraction spherical equivalent and the cycloplegic refraction spherical equivalent;
• If the subject has had Laser Vision Correction (LVC) within 1-2 years prior to the LSM procedure, stable distance refraction is present, defined as ≤ 0.50D variation of refraction in the 12 months prior to the LSM procedure. Manifest refraction spherical equivalent (MRSE) cannot vary more than 0.50D from current spectacles that are at least 12 months of age, or from a documented refraction at least 12 months prior to the preoperative baseline exam; if baseline data is available.
• Completed a washout period of two weeks (14 days) prior to LSM procedure from prior treatment with:

You may not qualify if:

• 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
• History of Dry Eye treatments/devices
• Pupil abnormalities (e.g., corectopia, Adie's)
• Capsule or zonular abnormalities
• Intraocular inflammation
• Retinal/macular disease or pathology
• Glaucoma (any type)
• History of prior ocular surgery, including:
• Previous corneal surgery (e.g., penetrating keratoplasty, DSEAK/DSEK/DMEK, lamellar keratoplasty), except for LASIK, SMILE, EpiLASEK, or PRK;
• Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) with the exception of uncomplicated phacoemulsification with intraocular lens implantation;
• Previous retinal surgery (e.g, retinal break, repair related to ocular trama or detachment, or pathology that is likely to require surgical intervention such as lattice degeneration.

Sponsors & Collaborators

• ACE Vision Group, Inc.: lead

Study Sites (1)

Asian Eye Institute

Makati City, 1200, Philippines

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Mitchell Jackson, MD

  Ace Vision Group

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 5, 2019
• Study Start: September 25, 2019
• Primary Completion: December 18, 2024
• Study Completion: February 28, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)