Evaluation of the Clinical Performance of In-Vitro Diagnostic System, Bio-M Pathfinder-a Fully Automated Cartridge-Based System, Designed for Rapid, Point-of-Care Biomarker Analysis for Ocular Disease Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- The proposed study will help establish the utility of a rapid diagnostic kit for clinical use in ophthalmic diseases. The efficiency and short turn-around -time of the test can significantly assist screening protocols in patients across a variety of ocular conditions, to enable better patient stratification, patient selection for surgery, treatment monitoring and long-term follow up. The study is expected to also reveal the application of individual biomarkers for specific disease types.
研究概览
简要总结
This prospective study will be commenced at Narayana Nethralaya eye hospital and GROW Research Laboratory, Narayana Nethralaya Foundation, Bangalore, India, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India, H. B. T. Medical College and Dr. R. N. Cooper Municipal Hospital, Mumbai, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry and M and J Institute of Ophthalmology, Civil Hospital, Ahmedabad.
Both Men and women that meet the inclusion/exclusion criteria and willing to provide written Informed Consent will be enrolled in the study.
Two groups of study participants will be recruited
Subjects over the age of 18 years will be separated into 2 groups.
Group 1
i.50 eyes tear samples will be collected from Healthy Subjects and used as a control.
ii.50 eyes aqueous humor samples will be collected from subjects without retinal disease undergoing cataract surgery as a control.
Group 2
i.50 eye samples will be collected from the subjects suffering from Ocular surface Diseases (Dry Eye Disease).
ii.50 eye samples will be collected from the subjects suffering from Retinal Diseases (Diabetic Retinopathy).
200 ocular fluid samples will be studied; Approximately 300 subjects will be screened. This may include single or multiple visits of subjects based on the clinical condition and the judgement of the treating clinician.
No follow-up visits from the patients will be required in this study.
Both Men and women that meet the inclusion/exclusion criteria and willing to provide written Informed Consent will be enrolled in the study.
Tear samples and aqueous humor samples will be collected to analyze biomarkers in ocular diseases using a variant of the multiplex ELISA, specific cartridges will be obtained for the measurement of IL-1b, IL-6, IL-10, IL-17A, MMP-9, ICAM-1, VEGF-A and TNF-A. Using a variant of the multiplex ELISA, specific cartridges will be obtained for the measurement of IL-1b, IL-6, IL-10, IL-17A, MMP-9, ICAM-1, VEGF-A and TNF-A. Samples from subjects with various kinds of ocular surface and retinal conditions will be tested.
The proposed study will help to establish the utility of a rapid diagnostic kit for clinical use in ophthalmic diseases. The efficiency and short duration of the test can significantly assist screening protocols in patients across a variety of ocular conditions, to enable better patient stratification, patient selection for surgery, treatment monitoring and long-term follow up. The study is expected to also reveal the application of individual biomarkers for specific disease types.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Following subjects will be included for the study: Tear samples from Dry Eye Disease patients and healthy controls without any ocular conditions.
- •Agree to sign the IEC approved informed consent form
- •Greater than or equal to 18 years of age, of any gender, able to read and respond to the clinical questionnaires and instructions.
- •Be willing or able to provide Schirmer’s tear samples, fill out the OSDI questionnaire, undergo TBUT test and return for all study visits and to follow instructions from the study investigator and his or her staff.
- •Inclusion criteria for DED group: Patient with reported dry eye related ocular symptoms at the screening visit or with history of active dry eye disease, which has not been resolved at the time of recruitment and sample collection.
- •Those classified as dry eye (DED) must demonstrate a.
- •Tear film break up time (TBUT) less than 10 s b.
- •Schirmer’s test less than 10 mm per 5min c.
- •OSDI score of at least
- •Inclusion criteria for tear sample controls: Those classified as healthy control and included in study must demonstrate: a.
- •Tear film break up time (TBUT) greater than 12 s b.
- •Schirmer’s test greater than 25 mm per 5min c.
- •OSDI score less than
- •Aqueous humor testing in Diabetic retinopathy and controls without retinal disease undergoing cataract surgery:
- •Greater than 50 years of age, of any gender, able to read and respond to the clinical questionnaires and instructions.
- •Be willing or able to provide aqueous humor samples, disease history, treatment history and return for all study visits and to follow instructions from the study investigator and his or her staff.
- •Inclusion Criteria for DR:
- •Those classified as Diabetic Retinopathy must demonstrate: a.
- •Known history of diabetes b.
- •Known history of retinal changes and currently active disease evidenced by retinal OCT and fundus imaging.
- •Those with disease requiring intervention and undergoing intraocular injections d.
- •ETDRS clinical grade corresponding to moderate or severe NPDR or PDR (score greater than 47) with or without retinal edema requiring intravitreal intervention
- •Patients with or without systemic diabetes control, presence of nephropathy or neuropathy associated with diabetes at the time of recruitment and sample collection can be included.
- •Inclusion criteria for aqueous humor controls: Those classified as control and included in study must demonstrate a.
- •No retinal changes on fundus and OCT imaging b.
- •ETDRS clinical grading corresponding to no disease (score less than 10).
排除标准
- •Following subjects will be excluded for the study: Tear samples from Dry Eye Disease patients and healthy controls without any ocular conditions.
- •Exclusion Criteria 1.Contact lens wear: Discontinuation of use of contact lenses within the last 30 days prior to the Screening Visit Unwilling to commit to no use of contact lenses for the next year 2.Pregnant or nursing or lactating 3.Participation in a study of an investigational drug or device within the 30 days preceding the Screening Visit 4.Current diagnosis of any of the following ocular conditions: ocular keratitis, acute allergic conjunctivitis, infection (e.g. bacterial, viral, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids), inflammation (e.g., retinitis, macular inflammation, choroiditis, uveitis, scleritis, episcleritis, keratitis) 5.Ocular surgery including cataract or LASIK surgery, glaucoma filtration surgery, retinal surgery, within 3 months of Screening Visit 6.Extensive ocular surface scarring or condition that may compromise ocular surface integrity such as Stevens-Johnson syndrome, prior chemical burn, recurrent corneal erosions, persistent corneal epithelial defects, prior ocular trauma, etc.) 7.Uncontrolled ocular or systemic disease, by patient report.
- •8.Cognitive or psychiatric deficit that precludes informed consent or ability to perform requirements of the investigation.
- •Exclusion Criteria for Tear sample Controls 1.Presence of any ocular disease 2.Use of any ongoing or prior anti-inflammatory or steroidal treatments in the last 6 months 3.Underwent any ocular or systemic surgery in the last 3 months 4.Self reported itching or ocular surface discomfort Exclusion Criteria for testing in Diabetic retinopathy and controls without retinal disease undergoing cataract surgery 1.Pregnant or nursing/lactating 2.Presence of advanced GA or wet AMD 3.History of intraocular/intravitreal injections or laser treatments for DR therapy in the last 6 months.
- •4.Participation in a study of an investigational drug or device within the 30 days preceding the Screening Visit 5.Current diagnosis of any of the following ocular conditions: ocular keratitis, acute allergic conjunctivitis, infection (e.g. bacterial, viral, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids), inflammation (e.g., retinitis, macular inflammation, choroiditis, uveitis, scleritis, episcleritis, keratitis) 6.Ocular surgery including cataract or LASIK surgery, glaucoma filtration surgery, retinal surgery, within 3 months of Screening Visit 7.Extensive ocular surface scarring or condition that may compromise ocular surface integrity such as Stevens-Johnson syndrome, prior chemical burn, recurrent corneal erosions, persistent corneal epithelial defects, prior ocular trauma, etc.) 8.Cognitive or psychiatric deficit that precludes informed consent or ability to perform requirements of the investigation.
- •Exclusion Criteria for aqueous humor Controls 1.Presence of any ocular disease except cataract (NS1-2, without PCO) 2.Use of any ongoing or prior anti-inflammatory or steroidal treatments in the last 6 months 3.Underwent any ocular or systemic surgery in the last 3 months 4.Presence of auto-immune conditions.
- •5.On systemic weight loss drugs 6.Any history of trauma, retinal injury.
结局指标
主要结局
The proposed study will help establish the utility of a rapid diagnostic kit for clinical use in ophthalmic diseases. The efficiency and short turn-around -time of the test can significantly assist screening protocols in patients across a variety of ocular conditions, to enable better patient stratification, patient selection for surgery, treatment monitoring and long-term follow up. The study is expected to also reveal the application of individual biomarkers for specific disease types.
时间窗: 8 Weeks
次要结局
未报告次要终点
研究者
Dr Thirumalesh MB
Narayana Nethralaya