Use of a Novel, Objective Optokinetic Contrast Device to Determine Scotopic Range Visual Function and Discriminate Between Patients With and Without Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Estimated Contrast Sensitivity in Log Units (logCS)
研究概览
简要总结
The purpose of this study is to determine if an optokinetic contrast detection device is sufficient to measure contrast sensitivity and to distinguish between patients with and without glaucoma.
详细描述
The protocol is divided into two studies that will have two separate consent forms (Study 1 and Study 2).
Study 1 involves the optimization of the device parameters. Study 1 will test adult subjects with no history of ocular disease (Study 1A) to assess the limits of human contrast sensitivity and subjects with definite glaucoma (Study 1B) by gathering preliminary data for comparison. These two pilot sub-studies intend to provide rapid data in regard to the device testing results to support the study hypothesis. This strategy will help rule out false negatives and false positives so that any adjustments can be made prior to the start of Study 2 for longitudinal data collection. Study 2 involves determination of baseline population parameters for an older population more likely to be age-matched with patients with glaucoma, as well as performance of patients with various levels of glaucoma severity.
Enrollment of participants in Study 1B will begin after the first 5 participants have been enrolled and tested in Study 1A. Study 2 will begin after Study 1A and B are complete.
Study 1: No more than 20 adult subjects with no history of ocular disease and no more than 20 adults subjects with definite glaucoma will be recruited to assist with optimization of device parameters.
Study 1A: The individuals will not be patients of the co-investigators but rather volunteers who are recruited by word of mouth (co-employees, residents, research staff, etc.) and are willing to volunteer their time to assist in the development of the project. Volunteers can be of any age >18, male or female, and must be of self-reported excellent ocular health. Best spectacle corrected visual acuity of 20/40 or better is required (verified by Snellen acuity testing on the day of participation) and the participant must have no reported history of glaucoma, retinal disease, amblyopia, ocular trauma, or ocular surgery of any kind with the exception of refractive surgery (LASIK, PRK, or equivalent).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal controls for Study 1
- •Male or Female
- •age 18 or older
- •Corrected visual acuity 20/40 or better in both eyes.
- •Normal Controls for Study 2
- •Male or Female
- •age 50 or older
- •IOP (intraocular pressure) 21 or less in both eyes
- •Corrected visual acuity 20/40 or better in both eyes.
- •Subjects with glaucoma/ocular hypertension
- •Male or Female
- •Age 50 or older
- •Defined as IOP> 21 without medication on two or more clinic visits in one or both eyes
- •Corrected visual acuity 20/40 or better
- •Normal optic nerves
- •Normal automated perimetry in both eyes
- •Subjects who are glaucoma/glaucoma suspects
- •Male or Female
- •Age 50 or over
- •Increased optic nerve cupping in one or both eyes regardless of IOP
- •Corrected visual acuity 20/40 or better
- •Normal automated perimetry in both eyes
- •Subjects with early to moderate glaucoma
- •Male or female
- •Age 50 or over
- •Increased optic nerve cupping regardless of IOP in one or both eyes
- •Corrected visual acuity 20/40 or better in both eyes
- •Early to moderate perimetric changes defined as a mean deviation (MD) no less than -7.5 and a pattern standard deviation (PSD) no greater than +7.5 in the worse eye.
- •Subjects with moderate to advanced glaucoma
- •Male of Female
- •Age 50 or older
- •Increased optic nerve cupping regardless of IOP in one or both eyes
- •Grossly abnormal automated perimetry (MD less than -7.5 or PSD greater than +7.5 in the worse eye)
- •Best-corrected visual acuity of 20/40 or better in both eyes
排除标准
- •Normal Controls (both studies):
- •glaucoma or glaucoma suspicion in either eye
- •IOP > 21 in either eye
- •History of use of IOP-reducing drops in either eye except temporarily following cataract extraction
- •History of any ocular surgery except cataract extraction or refractive surgery (LASIK, PRK, or equivalent) in either eye
- •Retinal disease in either eye
- •Abnormal measured automated perimetry in either eye
- •Abnormal measured contrast sensitivity in either eye
结局指标
主要结局
Estimated Contrast Sensitivity in Log Units (logCS)
时间窗: Study 1: Measured on the day of enrollment - reported only for those enrolled (early Termination). Study 2: Measured on the day of enrollment and 1 month later - not started (early Termination).
The HOCD willl be used to estimate the logCS of both eyes in both dark (scotopic) and light (photopic) conditions.
次要结局
- Compare Contrast Sensitivity Measured With the HOCD to Contrast Sensitivity Testing Via Pelli Robson Contrast Sensitivity Chart Testing.(Study 2: Measured 1 month after the day of enrollment - not started (early Termination).)
- Compare Log Contrast Sensitivity in Subjects With and Without Glaucoma(Study 1: Measured on the day of enrollment - reported only for those enrolled (early Termination). Study 2: Measured on the day of enrollment and 1 month later - not started (early Termination).)
- Compare Log Contrast Sensitivity Measured With the HOCD to White on White Sensitivity Via Automated Perimetry(Study 1: Measured on the day of enrollment - reported only for those enrolled (early Termination). Study 2: Measured on the day of enrollment - not started (early Termination).)
研究者
Benjamin Frankfort, MD, PhD
Associate Professor, Principal Investigator
Baylor College of Medicine