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临床试验/NCT05068479
NCT05068479终止不适用

Evaluation of the Safety & Efficacy of the Laser Scleral Microporation Procedure to Restore Visual Function and Range of Accommodation

ACE Vision Group, Inc.1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2021年4月29日最近更新:
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适应症

试验速览

阶段
不适用
状态
终止
入组人数
38
试验地点
1
主要终点
Binocular Uncorrected Near Visual Acuity (UNVA) @40cm
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
48 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Willing and able to understand and sign an informed consent;
  • •Willing and able to adhere to the instructions set forth in this protocol;
  • •48 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.
  • •Completed a washout period of two weeks (14 days) prior to LSM procedure from prior treatment with:
  • •With prior medical clearance: non steroidal anti-inflammatory drugs (NSAIDs), blood thinners, aspirin, and other substances which may increase bleeding; Anti-oxidants, which could affect blood thinning: Any antioxidant supplements (e.g., Vitamin E, Acai, Ocuvite, greater than 1000mg of Omega-3, etc); Antioxidant food supplements, such as shitake mushroom, mushroom extract and oral antioxidants

排除标准

  • •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.
  • •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 optical coherence tomography (OCT);
  • •History of nuclear sclerosis LOCS III grade 2 or worse and/or other cataracts reducing CDVA or (where measured at select sites) OSI > 2.5;
  • •Known allergies tp study medications including topical steroids, antibiotics and NSAIDs;
  • •Per Principal Investigator (PI) discretion, as described below:
  • •Note: This above list of exclusion criteria is not all inclusive. Investigators should use medical judgement to exclude patients that have diseases/conditions which may compromise study results and/or patients that are not ideal candidates. Patient affect and/or expectations may be included in the evaluation of candidacy.

结局指标

主要结局

Binocular Uncorrected Near Visual Acuity (UNVA) @40cm

时间窗: 12 months postoperative

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

次要结局

  • 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)
  • 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)
  • Binocular Distance Corrected Intermediate Near Acuity (DCNVA) @40cm(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • 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 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)
  • Monocular Best Corrected Distance Visual Acuity (CDVA) @4m(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Monocular Distance Corrected Near Visual Acuity (DCNVA) @40cm(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Determination of reading prescription(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 Distance Corrected Intermediate Visual Acuity (DCIVA) @60cm(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Monocular Best Corrected Near Visual Acuity (CNVA) @40cm(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Accommodative Amplitude using monocular minus lens to blur(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Accommodation testing(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Manifest refraction(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Binocular Best Corrected Distance Visual Acuity (CDVA) @4m(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) @60cm(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Accommodative Amplitude using binocular minus lens to blur(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Corneal topography(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Binocular contrast acuity(1 month postoperative; 12 months postoperative; 24 months postoperative)
  • Wavefront measurement(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Corneal tomography(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 24 months postoperative)
  • Pupillometry under photopic lighting conditions(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Cycloplegic refraction(12 months postoperative; 24 months postoperative)
  • Ultrasound biomicroscopy(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 24 months postoperative)
  • Dilated fundus exam(12 months postoperative; 24 months postoperative)
  • iReST reading test(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Auto-Keratometry(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Stereoacuity(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Pupillometry under mesopic lighting conditions(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Axial length measurement(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 24 months postoperative)
  • Monocular contrast acuity(1 month postoperative; 12 months postoperative; 24 months postoperative)
  • Intraocular pressure measurement(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)
  • Slitlamp examination(1 week postoperative; 1 month postoperative; 3 months postoperative; 6 months postoperative; 12 months postoperative; 18 months postoperative, 24 months postoperative)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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