Stop Retinal Ganglion Cell Dysfunction Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Retinal Nerve Fiber Layer Thickness
研究概览
简要总结
Glaucoma is a progressive disease resulting in blindness. Determining the onset of the disease, predicting its severity and the benefit of pressure lowering eye drops is key to clinical management aimed at maintaining useful vision with advancing age. This study will longitudinally monitor a population of glaucoma suspects (with positive factors for the disease but with normal vision) with noninvasive pattern electroretinogram (PERG) and other standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells (RGCs) that are the parent neurons of the optic nerve. RGCs may become dysfunctional before dying and their function restored with pressure-lowering eye drops. Glaucoma suspects with abnormal PERG will be randomized to treatment with eye drops, while those with normal PERG will be left untreated. All patients will be monitored with PERG, Optic Coherence Tomography (OCT) and other ancillary tests every 6 months over 4 years.
详细描述
The PERG is recorded from small metallic buttons taped on the skin similarly to an electrocardiogram, with the difference that the electrodes are around the eyes.
The only physical contact you will experience is a gentle cleaning of the skin with an alcohol prep pad. During the test you must look with both eyes at a Television (TV) display for about 3 minutes. During the follow up period you may be asked to take one more PERG test lying down in a bed.
This will cause a momentary increase of your eye pressure similar to the one that occurs during your normal sleep. This may help to understand whether or not your optic nerve functions normally when the pressure in your eye increases. For OCT evaluation, the pupil has to be dilated with drops as you did before for your eye exam. You have to briefly look at a mark inside the instrument one eye at a time.
PERG and OCT will be performed during the same day of your visit with the eye doctor. If you have already done these tests in the past, as part of another study or as part of your standard treatment, the results of these tests will be obtained from your record, and be included in this study.
If you are a participant in the Observation Group, you will be monitored with PERG, OCT, and standard clinical examinations every six months until close of study. If you are a participant in the Medication Group you will be also treated with eye drop medicines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 85 years, inclusive
- •Refractive errors within -5 to +3 diopters
- •Best corrected visual acuity (BCVA) better than or equal to 20/30 (Snellen)
- •Normal standard automated perimetry (SAP) according to the Ocular Hypertension Treatment Study (OHTS) criteria15 (reliability < 15% on all indices, normality > 5% on all global indices in two consecutive sessions 6 months apart)
- •Minimum untreated Intraocular pressure IOP of 15 mm Hg
- •Glaucoma Suspect Status defined as one or more of the following:
- •Glaucomatous optic disc appearance (vertical cup-to-disc ratio [C/D] ≥0.5
- •Cup disc ratio asymmetry ≥0.2
- •Localized thinning of the disc
- •Presence or history of splinter disc hemorrhage
- •Moderately increased IOP (>21 to <28 mm Hg).
- •Family history of vision loss for glaucoma
排除标准
- •Age-related macular degeneration
- •Parkinson's disease
- •Multiple sclerosis
- •Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
- •Pregnant or nursing women.
- •Currently using prescribed pressure lowering medicines and unwilling to be withdrawn from them.
- •An OHTS risk score high enough in the judgment of the ophthalmologist or optometrist managing the patient to recommend pressure lowering medicine to the patient and not randomization.
- •An OCT abnormal enough in a pattern consistent with glaucoma.
研究组 & 干预措施
Abnormal PERG Treated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to receive one or more drops in each eye in order to reduce the intraocular pressure by 20%.
Drugs could be:
Latanoprost 1 drop Once a day (QD) Bimatoprost 1 drop QD Travoprost 1 drop QD Timolol 1 drop Twice a day (BID) Dorzolamide 1 drop Three times a day (TID) Brinzolamide 1 drop BID Acetazolamide and Methazolamide depends on clinicians evaluation.
If Clinicians consider necessary, he/she might combine 2 drugs in order to get the desired intraocular pressure.
干预措施: Latanoprost (Drug)
Abnormal PERG Treated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to receive one or more drops in each eye in order to reduce the intraocular pressure by 20%.
Drugs could be:
Latanoprost 1 drop Once a day (QD) Bimatoprost 1 drop QD Travoprost 1 drop QD Timolol 1 drop Twice a day (BID) Dorzolamide 1 drop Three times a day (TID) Brinzolamide 1 drop BID Acetazolamide and Methazolamide depends on clinicians evaluation.
If Clinicians consider necessary, he/she might combine 2 drugs in order to get the desired intraocular pressure.
干预措施: Bimatoprost (Drug)
Abnormal PERG Treated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to receive one or more drops in each eye in order to reduce the intraocular pressure by 20%.
Drugs could be:
Latanoprost 1 drop Once a day (QD) Bimatoprost 1 drop QD Travoprost 1 drop QD Timolol 1 drop Twice a day (BID) Dorzolamide 1 drop Three times a day (TID) Brinzolamide 1 drop BID Acetazolamide and Methazolamide depends on clinicians evaluation.
If Clinicians consider necessary, he/she might combine 2 drugs in order to get the desired intraocular pressure.
干预措施: Travoprost (Drug)
Abnormal PERG Treated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to receive one or more drops in each eye in order to reduce the intraocular pressure by 20%.
Drugs could be:
Latanoprost 1 drop Once a day (QD) Bimatoprost 1 drop QD Travoprost 1 drop QD Timolol 1 drop Twice a day (BID) Dorzolamide 1 drop Three times a day (TID) Brinzolamide 1 drop BID Acetazolamide and Methazolamide depends on clinicians evaluation.
If Clinicians consider necessary, he/she might combine 2 drugs in order to get the desired intraocular pressure.
干预措施: Timolol (Drug)
Abnormal PERG Treated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to receive one or more drops in each eye in order to reduce the intraocular pressure by 20%.
Drugs could be:
Latanoprost 1 drop Once a day (QD) Bimatoprost 1 drop QD Travoprost 1 drop QD Timolol 1 drop Twice a day (BID) Dorzolamide 1 drop Three times a day (TID) Brinzolamide 1 drop BID Acetazolamide and Methazolamide depends on clinicians evaluation.
If Clinicians consider necessary, he/she might combine 2 drugs in order to get the desired intraocular pressure.
干预措施: Dorzolamide (Drug)
Abnormal PERG Treated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to receive one or more drops in each eye in order to reduce the intraocular pressure by 20%.
Drugs could be:
Latanoprost 1 drop Once a day (QD) Bimatoprost 1 drop QD Travoprost 1 drop QD Timolol 1 drop Twice a day (BID) Dorzolamide 1 drop Three times a day (TID) Brinzolamide 1 drop BID Acetazolamide and Methazolamide depends on clinicians evaluation.
If Clinicians consider necessary, he/she might combine 2 drugs in order to get the desired intraocular pressure.
干预措施: Brinzolamide (Drug)
Abnormal PERG Treated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to receive one or more drops in each eye in order to reduce the intraocular pressure by 20%.
Drugs could be:
Latanoprost 1 drop Once a day (QD) Bimatoprost 1 drop QD Travoprost 1 drop QD Timolol 1 drop Twice a day (BID) Dorzolamide 1 drop Three times a day (TID) Brinzolamide 1 drop BID Acetazolamide and Methazolamide depends on clinicians evaluation.
If Clinicians consider necessary, he/she might combine 2 drugs in order to get the desired intraocular pressure.
干预措施: Acetazolamide (Drug)
Abnormal PERG Treated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to receive one or more drops in each eye in order to reduce the intraocular pressure by 20%.
Drugs could be:
Latanoprost 1 drop Once a day (QD) Bimatoprost 1 drop QD Travoprost 1 drop QD Timolol 1 drop Twice a day (BID) Dorzolamide 1 drop Three times a day (TID) Brinzolamide 1 drop BID Acetazolamide and Methazolamide depends on clinicians evaluation.
If Clinicians consider necessary, he/she might combine 2 drugs in order to get the desired intraocular pressure.
干预措施: Methazolamide (Drug)
结局指标
主要结局
Retinal Nerve Fiber Layer Thickness
时间窗: Baseline
As measured by Optical Coherence Tomography in different timepoints as an absolute value in micrometers.
次要结局
- Pattern Electroretinogram Amplitude(Baseline)
- Pattern Electroretinogram Phase(Baseline)
研究者
Vittorio Porciatti
Professor
University of Miami