Study Stopped
The study was never initiated; Principal Investigator determined that it was not feasible to continue with the study at this time.
Mitochondrial DNA in Vitreous Fluid and Blood in Patients With Eye Disease or Ocular Trauma.
Investigation of the Relationship Between Mitochondrial DNA in Vitreous Fluid and Blood in Patients With Eye Disease or Ocular Trauma.
1 other identifier
observational
N/A
0 countries
N/A
Brief Summary
This study is to characterize mitochondrial DNA (mtDNA) populations in adults with eye injuries and eye diseases. The eye exam is often hindered by the clouding of tissues involved in injury or disease. This protocol examines the use of mtDNA populations as indicators of developing inflammation and resolution of injury. This may be used to provide proactive treatment or define appropriate treatment needs beyond the indications of an ophthalmological exam.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2020
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 21, 2020
CompletedFirst Submitted
Initial submission to the registry
April 1, 2020
CompletedFirst Posted
Study publicly available on registry
April 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2022
CompletedMarch 23, 2023
March 1, 2023
2.8 years
April 1, 2020
March 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quantitation of mitochondrial DNA in vitreous humor and serum samples
mtDNA quantitation by RTq-PCR
1 day
Secondary Outcomes (1)
Evaluation of mtDNA quantitation versus ocular comorbidities as described in electronic medical record.
1 month
Study Arms (5)
Age Related Macular Degeneration
Subjects with Age Related Macular Degeneration upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Glaucoma
Subjects with Glaucoma upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Diabetic Retinopathy
Subjects with Diabetic Retinopathy upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Ocular Trauma
Subjects with Ocular Trauma upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Control
Subjects with no ocular disease or trauma comorbidities upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Interventions
Collection of vitreous humor tissue and venous blood from subjects undergoing ocular surgery that may provide vitreous humor discarded tissue.
Eligibility Criteria
Subjects suffering eye disease or ocular trauma and healthy subjects undergoing ocular surgery which may include the discard of vitreous humor.
You may qualify if:
- a) Target group
- Age ≥ 20 years old
- Subjects must not be nursing, pregnant or planning to become pregnant. Subjects of child bearing potential must have a documented negative pregnancy test at the time of preoperative assessment or not be of child bearing potential. Identified eye disease including but not limited to age-related macular degeneration, glaucoma and/or diabetic retinopathy.
- Scheduled ophthalmic surgery with expected vitreal humor discard.
- Subject has provided written informed consent to participate in this protocol. b) Control group
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- Age ≥ 20 years old
- Subjects must not be nursing, pregnant or planning to become pregnant. Subjects of child bearing potential must have a documented negative pregnancy test at the time of preoperative assessment or not be of child bearing potential.
- Lack of identified eye disease.
- Scheduled ophthalmic surgery with expected vitreal humor discard.
- Subject has provided written informed consent to participate in this protocol.
You may not qualify if:
- a) Target group
- Age \< 20 years old
- Subject is nursing, pregnant, planning to become pregnant or of child bearing potential and does not agree to the use of reliable method of contraception during their participation in the study. A pregnancy test must be administered to women of childbearing potential at the time of preoperative assessment.
- Identified eye disease including but not limited to age-related macular degeneration, glaucoma and/or diabetic retinopathy.
- Subject has not completed informed consent to participate in this protocol. b) Scheduled ophthalmic surgery with expected vitreal humor discard Control group
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- Age \< 20 years old
- Subject is nursing, pregnant, planning to become pregnant or of child bearing potential and does not agree to the use of reliable method of contraception during their participation in the study. A pregnancy test must be administered to women of childbearing potential at the time of preoperative assessment.
- Lack of identified eye disease.
- Subject has not completed informed consent to participate in this protocol. Scheduled ophthalmic surgery with expected vitreal humor discard.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Samples of vitreous humor and plasma will be collected for analysis of mtDNA by RTq-PCR. Remaining samples will be maintained in a de-identified state for unidentified future research without additional consent.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bartosz Szczesny, Ph.D.
University of Texas
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2020
First Posted
April 6, 2020
Study Start
February 21, 2020
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Last Updated
March 23, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share
Study records will be kept confidential as required by law. Except when required by law, your identifiers will not be disclosed outside of the University of Texas Medical Branch (UTMB). For records disclosed outside of UTMB, you will be assigned a unique code number. The key to this code will be kept in a password protected encrypted format on a limited access server behind the UTMB firewall. It will be destroyed at the end of data collection for this study. Study samples will also be kept in a de-identified state with the same 4 digit code as the data collection. These samples will be maintained in secured laboratories of the Department of Ophthalmology. The de-identified samples may be maintained past the end of the study for future research without additional consent. Future researchers will have no information on the identity of the subjects.