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

NCT04151446 | Terminated

• 1 other identifier: TWAVG-2017-01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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

Keywords

Presbyopia; Sclera; Laser Scleral Microporation

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 performed under photopic lighting conditions.

  12 months postoperative

Secondary Outcomes (24)

• Patient Self-Reporting Questionnaire 1

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

• Patient Self-Reporting Questionnaire 2

  3 Day, 1 week; 1 month; 3 months; 6 months; 12 months; 18 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

• 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)

Laser Scleral Microporation procedure

EXPERIMENTAL

Patients suffering from presbyopia will receive bilateral Laser Scleral Microporation procedure.

Device: Laser Scleral Microporation

Interventions

Laser Scleral Microporation DEVICE

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

Laser Scleral Microporation procedure

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• 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 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
• Reduced near visual acuity at 40 cm 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 and the cycloplegic refraction;
• 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.
• Completed a washout period of two weeks (14 days) prior to Laser Scleral Microporation 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
• 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;
• 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);
• Previous corneal surgery (e.g., corneal transplant, DSAEK/DSEK, lamellar keratoplasty), except for LASIK, EpiLASIK/LASEK, or PRK;
• Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy);

Sponsors & Collaborators

• ACE Vision Group, Inc.: lead
• Vision Renu Taiwan Corporation: collaborator

Study Sites (2)

Chang Gung Memorial Hospital, Keelung

Keelung, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 22078121 BACKGROUND

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• David Ma, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Arvin Sun, MD

  Chang Gung Memorial Hospital, Keelung

  PRINCIPAL INVESTIGATOR

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: April 23, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 3, 2022

Record last verified: 2021-10

Locations

TW (2)