Health Condition 1: H049- Disorder of lacrimal system, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Intervention4: Nil: Nil
Sponsors
NovoMol-Dx Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Following subjects will be included for the study: Tear samples from Dry Eye Disease patients and healthy controls without any ocular conditions. 1. Agree to sign the IEC approved informed consent form 2. Greater than or equal to 18 years of age, of any gender, able to read and respond to the clinical questionnaires and instructions. 3. 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. 4. 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. 5. 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 14. 6. 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 12. Aqueous humor testing in Diabetic retinopathy and controls without retinal disease undergoing cataract surgery: 1. Agree to sign the IEC approved informed consent form 2. Greater than 50 years of age, of any gender, able to read and respond to the clinical questionnaires and instructions. 3. 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: 4. 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. c. 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 5. 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. 6. 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).
Exclusion criteria
Exclusion criteria: 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. <br
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 8 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Thirumalesh MB
Narayana Nethralaya
Outcome results
None listed