Mitochondrial DNA in Vitreous Fluid and Blood in Patients With Eye Disease or Ocular Trauma.

March 22, 2023 updated by: The University of Texas Medical Branch, Galveston

Investigation of the Relationship Between Mitochondrial DNA in Vitreous Fluid and Blood in Patients With Eye Disease or Ocular Trauma.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study aim to test correlation between the presence of the mitochondrial DNA in vitreous fluid and blood in patients that are admitted to UTMB's Eye clinic. The goal of the study is to analyze 4 groups of 30 samples of each major ocular disease and injury: age-related macular degeneration, glaucoma and diabetic retinopathy and ocular trauma. Up to 300 subjects may be consented to this study in order to meet recruitment goals. In this study we will use only otherwise discarded eye's vitreous together with a blood sample that is collected during surgery. Patients with ophthalmic surgery scheduled that may result in discarded vitreal fluid will be identified from the clinic schedule or by physician in the emergency room. The possibility of vitreous collection in a surgery may be uncertain. If a subject does not have discarded vitreous from a given surgery they will be screen failed prior to blood draw or data collection from electronic medical record from that moment forward. Subjects will be approached when appropriate for interest in participation in the study by their clinical faculty surgeon. An informed consent briefing will be provided by the clinical research coordinator with an opportunity to ask questions of both the coordinator, the clinical faculty surgeon and the principle investigator. Copies of the consent will be provided for the patient to take home. Additional opportunity for questions the morning of surgery will be provided. Consent signature will be obtained prior to any medication administration the upon admission for surgery. Samples if available will be collected during the eye surgery. Up to 1ml of vitreous fluid and up to 10 ml of blood will be collected from each patient. Samples will be stored at room temperature and transferred directly to Dr. Szczesny's laboratory. Vitreous fluid will be frozen for further analysis and blood plasma will be processed using histopaque and centrifugation prior freezing. Two types of analysis will be conducted with collected biospecimens.1) Total DNA will be isolated, follow by analysis with real-time quantitative polymerase chain reaction (RTq-PCR) using set of primers to identify the presence of the mitochondrial DNA and nuclear DNA as a control. 2) Extracellular vesicles will be isolated using ultracentrifugation or commercially available kit followed by analysis of the mitochondrial and nuclear DNA and/or plasma membrane markers using RTq-PCR and/or Western blot. Electronic medical records will be accessed to collect demographics and ophthalmologic diagnostic information and information on other comorbidity diagnoses.

These data points will include age in years, gender, race, ethnicity, presence of age related macular degeneration(AMD) (y/n), type and stage of AMD, use of AREDs vitamins, treatments of AMD, Glaucoma(y/n), type and stage of glaucoma, diabetes, blood glucose, diabetic retinopathy (y/n), type and stage of diabetic retinopathy, treatments of diabetic retinopathy and amount of time prior to this planned surgery, hypertension type and stage, renal disease type and stage, smoking history, cancer, cancer type, treatment or surgery, viral diagnoses (HIV, CMV, HCV), blunt eye trauma history, cataract history, lens removal surgery, cause of vitrectomy, concomitant medications and procedures, eye exam observations relevant to inflammatory processes, Optical coherence tomography data. IOP, visual field [VF] data, visual acuity, gonioscopic findings,.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Stacy M Schreiber-Lopez, MA
  • Phone Number: 4097475483
  • Email: smschrei@utmb.edu

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555-1106
        • Recruiting
        • University of Texas Medical Branch, Ophthalmology Clinical Research Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bartosz Szczesny, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects suffering eye disease or ocular trauma and healthy subjects undergoing ocular surgery which may include the discard of vitreous humor.

Description

Inclusion Criteria:

  • a) Target group

    1. Age ≥ 20 years old
    2. 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.
    3. Scheduled ophthalmic surgery with expected vitreal humor discard.
    4. Subject has provided written informed consent to participate in this protocol. b) Control group
    1. Age ≥ 20 years old
    2. 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.
    3. Lack of identified eye disease.
    4. Scheduled ophthalmic surgery with expected vitreal humor discard.
    5. Subject has provided written informed consent to participate in this protocol.

Exclusion Criteria:

  • a) Target group

    1. Age < 20 years old
    2. 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.
    3. Identified eye disease including but not limited to age-related macular degeneration, glaucoma and/or diabetic retinopathy.
    4. Subject has not completed informed consent to participate in this protocol. b) Scheduled ophthalmic surgery with expected vitreal humor discard Control group
    1. Age < 20 years old
    2. 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.
    3. Lack of identified eye disease.
    4. Subject has not completed informed consent to participate in this protocol. Scheduled ophthalmic surgery with expected vitreal humor discard.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Age Related Macular Degeneration
Subjects with Age Related Macular Degeneration upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Other: Sample collection from tissue discard
Collection of vitreous humor tissue and venous blood from subjects undergoing ocular surgery that may provide vitreous humor discarded tissue.
Glaucoma
Subjects with Glaucoma upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Other: Sample collection from tissue discard
Collection of vitreous humor tissue and venous blood from subjects undergoing ocular surgery that may provide vitreous humor discarded tissue.
Diabetic Retinopathy
Subjects with Diabetic Retinopathy upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Other: Sample collection from tissue discard
Collection of vitreous humor tissue and venous blood from subjects undergoing ocular surgery that may provide vitreous humor discarded tissue.
Ocular Trauma
Subjects with Ocular Trauma upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Other: Sample collection from tissue discard
Collection of vitreous humor tissue and venous blood from subjects undergoing ocular surgery that may provide vitreous humor discarded tissue.
Control
Subjects with no ocular disease or trauma comorbidities upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Other: Sample collection from tissue discard
Collection of vitreous humor tissue and venous blood from subjects undergoing ocular surgery that may provide vitreous humor discarded tissue.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quantitation of mitochondrial DNA in vitreous humor and serum samples
Time Frame: 1 day
mtDNA quantitation by RTq-PCR
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of mtDNA quantitation versus ocular comorbidities as described in electronic medical record.
Time Frame: 1 month
Collection of comorbidity data from electronic medical record and comparison with quantiative analysis of mtDNA.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Medical Branch, Galveston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bartosz Szczesny, Ph.D., University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-0291

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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