Clinical trial NCT04151550: Safety & Efficacy of the Laser Scleral Microporation Procedure (Philippines)
Official title: Evaluation of the Safety and Efficacy of the Laser Scleral Microporation Procedure to Restore Visual Function and Range of Accommodation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: Presbyopia
Sclera
Laser Scleral Microporation
Lead sponsor: ACE Vision Group, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-05
Enrollment: 50
Sex: ALL
Minimum age (years): 48
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Willing and able to understand and sign an informed consent;
2. Willing and able to attend postoperative examinations per protocol schedule;
3. 48 years of age or greater, of either gender or any race;
4. Less than (\<) 1.00D of astigmatism in each eye, measured by manifest refraction;
5. Mean Refractive Spherical Equivalent (MRSE) of less than or equal to 0.50D for distance vision;
6. 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;
7. Demonstrate stereopsis of 100 seconds of arc or better using a Stereo Fly test with near correction;
8. In good ocular health with the exception of presbyopia;
9. Presbyopia as demonstrated by:

   1. Currently wearing reading glasses and/or bifocals with an ADD of +1.50D or more at 40cm in each eye; and
   2. Reduced near visual acuity at 40cm when corrected for distance (DCNVA) of 20/50 (logMAR 0.40) or worse in each eye;
10. Intraocular pressure (IOP) ≥ 11mmHg and ≤ 30 mmHg in each eye without IOP-lowering medication;
11. Less than or equal to (≤) 0.50D difference between the manifest refraction spherical equivalent and the cycloplegic refraction spherical equivalent;
12. 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.
13. Completed a washout period of two weeks (14 days) prior to LSM procedure from prior treatment with:

    a) With prior medical clearance: non-steroidal anti-inflammatory drugs (NSAIDs), blood thinners, aspiring and other substances which may increase bleeding; b) Anti-oxidants, which could affect blood thinning: (i) Any antioxidant supplements (e.g., Vitamin E, Acai, Ocuvite, greater than 1000mg of Omega-3, etc.); (ii) Antioxidant food supplements, such as shitake mushroom, mushroom extract and oral antioxidants

Exclusion Criteria:

1. Self-reported current pregnancy or breast-feeding, or plans to become pregnant during the entire study period;
2. History of ocular trauma or prior ocular surgery, or expected to require retinal laser treatment or other ocular surgical intervention;
3. Presence of ocular pathology other than cataract such as:

   1. Amblyopia or strabismus
   2. Corneal abnormalities or disease
   3. History of Dry Eye treatments/devices
   4. Pupil abnormalities (e.g., corectopia, Adie's)
   5. Capsule or zonular abnormalities
   6. Intraocular inflammation
   7. Retinal/macular disease or pathology
   8. Glaucoma (any type)
4. History of prior ocular surgery, including:

   1. Previous corneal surgery (e.g., penetrating keratoplasty, DSEAK/DSEK/DMEK, lamellar keratoplasty), except for LASIK, SMILE, EpiLASEK, or PRK;
   2. Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) with the exception of uncomplicated phacoemulsification with intraocular lens implantation;
   3. 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.
5. 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);
6. Keratoconus or keratoconus suspect with CDVA of less than (\<) 20/20 (logMAR 0.00) at distance;
7. Near visual acuity at 40cm equivalent to their distance vision with distance correction (i.e., no evident effect of reduced accommodative range);
8. Use of systemic or ocular medications that may affect vision (the use of any miotic or cycloplegic agent is specifically contraindicated);
9. 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);
10. Uncontrolled systemic or ocular disease;
11. Any abnormality preventing reliable applanation tonometry in EITHER eye;
12. Undilatable pupil such that one cannot examine the periphery of the retina;
13. Functional eye preference, defined as phoria measuring over 15 prism diopters (PD) horizontally and/or over 2 PD vertically, any strabismus, or suppression.
14. History of scleral ectasia, scleritis, or episcleritis: or thin sclera \< 400 microns, as determined by taking the average of three measurements with ultrasound biomicroscopy (UBM) pachymetry or ocular coherence tomography;
15. History of nuclear sclerosis LOCS III grade 2 or worse and/or other cataracts reducing CDVA or OSI \> 2.5;
16. Known allergies to study medications including topical steroids, antibiotics and NSAIDs;
17. Per Principal Investigator (PI) discretion

Primary outcomes:
measure: Binocular Distance Corrected Near Visual Acuity (DCNVA) @40cm
timeFrame: 12 months postoperative
Secondary outcomes:
measure: Autorefraction
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Monocular Uncorrected Distance Visual Acuity (UDVA) @4m
timeFrame: 1 day; 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Binocular Uncorrected Distance Visual Acuity (UDVA) @4m
timeFrame: 1 week; 1 month ; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Monocular & Binocular Uncorrected Intermediate Visual Acuity (UIVA) @60cm
timeFrame: 1 week 1 month; 3 months 6 months; 12 months; 18 months & 24 months postoperative
measure: Monocular & Binocular Uncorrected Near Visual Acuity (UNVA) @40cm
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Manifest Refraction
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Monocular & Binocular Best Corrected Distance Visual Acuity (CDVA) @4m
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Monocular & Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) @60cm
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Monocular Distance Corrected Near Visual Acuity (DCNVA) @40cm
timeFrame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
measure: Monocular Best Corrected Near Visual Acuity (DCNVA) @40cm
timeFrame: 1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative
measure: Accommodative Amplitude using binocular & monocular minus lens to blur
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: IReST
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Stereoacuity
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Contrast Sensitivity
timeFrame: 1 month postoperative; 12 months postoperative; 24 months postoperative
measure: Wavefront Aberrometry
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Effective Range of Focus
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months & 24 months postoperative
measure: Optical Scatter
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months & 24 months postoperative
measure: Intraocular Pressure
timeFrame: 1, Day, 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: UBM Accommodation
timeFrame: 1 month; 12 month & 24 month postoperative
Other outcomes:
Locations:
city: Makati City
country: Philippines
facility: Asian Eye Institute
Study officials:
affiliation: Ace Vision Group
name: Mitchell Jackson, MD
role: STUDY_DIRECTOR
References: