NCT01491360已完成不适用
Evaluation of the Safety & Efficacy of the LaserACE® Procedure to Restore Visual Function and Range of Accommodation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Percent of subjects with binocular near visual acuity of 20/32 (logMAR 0.20) or better at six months postoperatively with distance correction in place measured at 40cm and 60cm.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to understand and sign an informed consent;
- •Willing and able to attend postoperative examinations per protocol schedule;
- •40 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 LaserACE® 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 20/32 (logMAR 0.20) in each eye;
- •Demonstrate Stereopsis of 200 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; and
- •Reduced near visual acuity when corrected for distance (DCNVA of 20/50 (logMAR 0.40) or worse; and
- •Amplitude of accommodation (AA) of 1.50D or less as measured by the minus lens test; OR
- •Amplitude of accommodation (AA) of 1.50D or less as measured by the iTrace aberrometer.
- •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 LaserACE® 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;
- •Completed a washout period of two weeks (14 days) prior to LaserACE® procedure from prior treatment with:
- •NSAIDS, blood thinners, aspirin, and other substances which may increase bleeding;
- •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
- •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 (International Task Force Level 3 or greater)
- •Pupil abnormalities (e.g., corectopia, Adie's)
- •Capsule or zonnular 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 radial keratotomy or other 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);
- •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;
- •History of nuclear sclerosis LOCS III grade 2 or worse and/or other cataracts reducing CDVA;
- •Known allergies to study medications including topical steroids, antibiotics and NSAIDS;
- •Per PI discretion
排除标准
- 未提供
结局指标
主要结局
Percent of subjects with binocular near visual acuity of 20/32 (logMAR 0.20) or better at six months postoperatively with distance correction in place measured at 40cm and 60cm.
时间窗: 6 months
binocular near visual acuity of 20/32 (logMAR 0.20) or better at six months postoperatively with distance correction in place measured at 40cm and 60cm.
次要结局
未报告次要终点
研究者
研究点 (1)
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