Clinical trial NCT04151446: Safety & Efficacy of the Laser Scleral Microporation Procedure (Taiwan)
Official title: Evaluation of the Safety & Efficacy of the Laser Scleral Microporation Procedure to Restore Visual Function and Range of Accommodation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Presbyopia
Keywords: Presbyopia
Sclera
Laser Scleral Microporation
Lead sponsor: ACE Vision Group, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Vision Renu Taiwan Corporation
First posted: 2019-11-05
Enrollment: 11
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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. 45 years of age or greater, of either gender or any race;
4. Less than (\<) 1.00D of astigmatism in each eye, measured in their manifest refraction;
5. 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.
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 Randot stereoscopic fly test and reading 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 40 cm in each eye; and
   2. Reduced near visual acuity at 40 cm 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 and the cycloplegic refraction;
12. Stable distance refraction is present, defined as ≤ 0.50D variation of refraction in the 12 months prior to the Laser Scleral Microporation procedure. Manifest refraction 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 Laser Scleral Microporation procedure from prior treatment with:

    * With prior medical clearance: NSAIDS, blood thinners, aspirin, and other substances which may increase bleeding;
    * Anti-oxidants, which could affect blood thinning14

      * Any anti-oxidant supplements (e.g., Vitamin B6, Vitamin B12, Vitamin E, Vitamin C, Acai, Ocuvite, etc);
      * Anti-oxidant food supplements, such as shitake mushroom, mushroom extract and oral anti-oxidants.

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:

   * 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
   * Glaucoma (any type)
   * History of prior ocular surgery other than keratorefractive surgery;
4. 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);
5. Previous corneal surgery (e.g., corneal transplant, DSAEK/DSEK, lamellar keratoplasty), except for LASIK, EpiLASIK/LASEK, or PRK;
6. Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy);
7. Keratoconus or keratoconus suspect with CDVA of less than (\<) 20/20 (\< logMAR 0.00) at distance;
8. Near visual acuity at 40cm equivalent to their distance vision with distance correction (i.e., no evident effect of reduced accommodative range);
9. Use of systemic or ocular medications that may affect vision (the use of any miotic or cycloplegic agent is specifically contraindicated);
10. 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);
11. Uncontrolled systemic or ocular disease;
12. Any abnormality preventing reliable applanation tonometry in EITHER eye;
13. Undilatable pupil such that one cannot examine the periphery of the retina;
14. Functional eye preference, defined as phoria measuring over 15dp horizontally and/or over 2dp vertically, any strabismus, or suppression.
15. History of scleral ectasia, scleritis, or episcleritis
16. History of nuclear sclerosis LOCS III grade 2 or worse and/or other cataracts reducing CDVA;
17. Known allergies to study medications including topical steroids, antibiotics and NSAIDS;
18. Too thin sclera thickness
19. Per PI discretion, as described below:

Primary outcomes:
measure: Binocular Uncorrected Near Visual Acuity (UNVA) @ 40cm
timeFrame: 12 months postoperative
Secondary outcomes:
measure: Patient Self-Reporting Questionnaire 1
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Patient Self-Reporting Questionnaire 2
timeFrame: 3 Day, 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Monocular & 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 & Binocular Distance Corrected Near Visual Acuity (DCNVA) @ 40cm
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Determination of reading prescription
timeFrame: 1 week; 1 month; 3 months; 6 months ; 12 months; 18 months & 24 months postoperative
measure: Accommodative Amplitude using binocular & monocular minus lens to blur
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months & 24 months postoperative
measure: iReST reading test
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months & 24 months postoperative
measure: Wavefront Aberrometry
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Auto-Keratometry
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Corneal Topography
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Speedy-i Accommodation Testing
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months & 24 months postoperative
measure: Stereoacuity
timeFrame: 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Pupillometry
timeFrame: 1 day, 3 day, 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Contrast Sensitivity
timeFrame: 1 month; 12 months & 24 months postoperative
measure: Axial Length Measurement
timeFrame: 1 month; 12 months & 24 months postoperative
measure: Slit Lamp Examination
timeFrame: 1 day, 3 days, 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Intraocular Pressure Measurement
timeFrame: 1 day, 3 days, 1 week; 1 month; 3 months; 6 months; 12 months; 18 months & 24 months postoperative
measure: Cycloplegic refraction
timeFrame: 1 month; 12 months & 24 months postoperative
measure: Dilated Fundus exam
timeFrame: 1 month; 12 months & 24 months postoperative
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital, Keelung
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
Study officials:
affiliation: Chang Gung Memorial Hospital
name: David Ma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital, Keelung
name: Arvin Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buckhurst PJ, Wolffsohn JS, Gupta N, Naroo SA, Davies LN, Shah S. Development of a questionnaire to assess the relative subjective benefits of presbyopia correction. J Cataract Refract Surg. 2012 Jan;38(1):74-9. doi: 10.1016/j.jcrs.2011.07.032. Epub 2011 Nov 10.