Safety & Efficacy of the Laser Scleral Microporation Procedure

NCT05068479 | Terminated

• 1 other identifier: PAN-AVG-PRES-2020-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Binocular Uncorrected Near Visual Acuity (UNVA) @40cm

  Binocular UNVA is measured with ETDRS charts placed in 40cm distance. This assessment is done binocularly under photopic light conditions.

  12 months postoperative

Secondary Outcomes (34)

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

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

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

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

• Monocular Uncorrected Intermediate Visual Acuity (UIVA) @60cm

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

• Binocular Uncorrected Intermediate Visual Acuity (UIVA) @60cm

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

• Monocular Uncorrected Near Visual Acuity (UNVA) @40cm

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

Study Arms (2)

Natural Emmetropic Presbyopes

EXPERIMENTAL

Patients that did not undergo any vision correcting surgery or implantation of an intraocular lens but suffering from presbyopia will receive bilateral Laser Scleral Microporation procedure.

Device: Bilateral Laser Scleral Microporation procedure

Post Laser Vision Correction (LVC) Emmetropic Presbyopes

EXPERIMENTAL

Patients that underwent laser vision correction procedure (e.g. LASIK) in the past and suffering from presbyopia will receive bilateral Laser Scleral Microporation procedure.

Device: Bilateral Laser Scleral Microporation procedure

Interventions

Bilateral Laser Scleral Microporation procedure DEVICE

Partial depth scleral microporations with an Er:YAG laser in a predetermined pattern.

Natural Emmetropic Presbyopes; Post Laser Vision Correction (LVC) Emmetropic Presbyopes

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 adhere to the instructions set forth in this protocol;
• years of age or greater, of either gender or any race;
• Less than (\<) 1.00D of astigmatism in each eye, measured by manifest refraction;
• Manifest refraction spherical equivalent refraction (MRSE) of less than or equal to +/- 0.50D for distance vision; Note: Subjects who meet this criterion as a result of prior laser refractive surgery may qualify; however, the subject must have had the Laser Vision Correction (LVC) at least 12 months prior to the LSM 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 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; and
• Minimum non-adjusted NAVQ score of 10;
• 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 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.

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 (example: hot compresses, punctal plugs, automated or manual thermal expression, intense pulse light, nasolacrimal stimulation, thermal lid treatments, or any dry eye medications such as Cyclosporine, liftegrast, or topical steroids) 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, EpiLASIK/LASEK, or PRK; Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy); Previous retinal surgery (e.g. retinal break, repair related to ocular trauma or detachment, or pathology that is likely to require surgical intervention such as lattice degeneration
• Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 (logMAR 0.18) or worse (e.g., macular degeneration);
• Keratoconus or keratoconus suspect with CDVA of less than (\<) 20/20 (logMAR \> 0.00) at distance;
• Near visual acuity at 40cm equivalent to their distance vision with distance correction (i.e., no evident effect of reduced accommodative range);
• Use of systemic or ocular medications that may affect vision (the use of any miotic or cycloplegic agent is specifically contraindicated);
• Acute or chronic disease or illness that could increase the operative risk or confound the study outcome(s) (e.g., diabetes mellitus, immunocompromised, connective tissue disease);
• Uncontrolled systemic or ocular disease;
• Any abnormality preventing reliable applanation tonometry in EITHER eye;
• Undilatable pupil such that one cannot examine the periphery of the retina;
• Functional eye preference, defined as phoria measuring over 15dp horizontally and/or over 2dp vertically, any strabismus, or suppression.

Sponsors & Collaborators

• ACE Vision Group, Inc.: lead

Study Sites (1)

Panama Eye Center

Panama City, Panama

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 5, 2021
• Study Start: April 29, 2021
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)