Traction Retinal DetachmentsVISIANCT02574624
Vitreous Surgery With Intraocular Assistance
A study testing Intraocular assistance in people with Traction Retinal Detachments and Rhegmatogenous Retinal Detachments, run by Johns Hopkins University at 1 site in United States.
Trial summary
To Assess the Safety of Vitreous surgery with intraocular assistance (VISIA) \& to identify and document with video evidence and surgeon's case report forms intraocular maneuvers that are facilitated by VISIA. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Traction Retinal Detachments, Rhegmatogenous Retinal Detachments, Dislocated Intraocular Lens
- What is being tested?
- Intraocular assistance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects must meet the following criteria to be eligible for study entry:
- Signed informed consent and authorization of use and disclosure of protected health information
- Age ≥18 years
- Subject will have complex retinal pathology for which it is judged that surgical objectives could be facilitated by VISIA
Who cannot join
- Subjects who meet any of the following criteria will be ineligible for study entry:
- Patients with disease processes such as macular pucker and macular hole that are generally well-managed by standard two-handed vitrectomy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wilmer Eye Institute, Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
Official title: Vitreous Surgery With Intraocular Assistance (VISIA)
To Assess the Safety of Vitreous surgery with intraocular assistance (VISIA) \& to identify and document with video evidence and surgeon's case report forms intraocular maneuvers that are facilitated by VISIA.
Read the detailed description
Standard care surgery will be done with a few novel additions to facilitate the surgical procedure. Currently 3 ports are inserted by creating holes in the sclera (white part of the eye) to enter into the posterior part of the eye. When complex dissection is needed, a fourth port will be inserted. The assistant will insert light source through the 4th port. This eliminates the need for the surgeon to hold the light in one hand. Hence allows freeing of both hands for the surgeon to use a forceps in one hand to grasp and elevate membranes and a scissors in the other to cut connections between the retina and the membranes. When membranes are particularly thick, it can be difficult to dissect with a single forceps holding up the membrane. In this situation, a 5th port will be inserted allowing the assistant to insert a light source through one and a forceps though another. The surgeon will have a forceps in one hand and a scissors in another making dissection process more efficient.
- Conditions
- Traction Retinal Detachments, Rhegmatogenous Retinal Detachments, Dislocated Intraocular Lens
- Being tested
- Intraocular assistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular assistanceProcedure or surgery
Intraocular assistance with help of surgical assistants during vitreous surgery (VISIA) in patients who require vitreous surgeries as part of standard of care procedure for conditions like retinal detachments, dislocated intraocular lens and glaucoma patients requiring endophotocoagulation.
| Study group | Role | What they receive |
|---|---|---|
| Intraocular Assistance | Experimental | Intraocular assistance in patients undergoing standard of care vitreous surgeries Receives: Procedure: Intraocular assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is recording of adverse events directly related to VISIA and adverse events unrelated to VISIA.
Measured: 4 months
Secondary outcomes (2)
Surgeon's assessment of the benefits and risks of VISIA recorded on the surgical case report form.
Measured: 4 months
Assistant's assessment of the benefits and risks of VISIA recorded on the surgical case report form.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: Difficulty in finding patients with complex retinal pathology to enroll in this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traction Retinal DetachmentsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter A Campochiaro, MD, Johns Hopkins University
- Investigators
- Peter A. Campochiaro, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574624
- Sponsor's protocol ID
- VISIA
- Acronym
- VISIA
- Status last verified
- Sep 2017
- First submitted
- 24 Sep 2015
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitreous Surgery With Intraocular Assistance (VISIA)
- ClinicalTrials.gov ID
- NCT02574624
- Acronym / sponsor ID
- VISIA / VISIA
- Conditions
- Traction Retinal Detachments, Rhegmatogenous Retinal Detachments, Dislocated Intraocular Lens
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in finding patients with complex retinal pathology to enroll in this study.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To Assess the Safety of Vitreous surgery with intraocular assistance (VISIA) \& to identify and document with video evidence and surgeon's case report forms intraocular maneuvers that are facilitated by VISIA.
Detailed description
Standard care surgery will be done with a few novel additions to facilitate the surgical procedure. Currently 3 ports are inserted by creating holes in the sclera (white part of the eye) to enter into the posterior part of the eye. When complex dissection is needed, a fourth port will be inserted. The assistant will insert light source through the 4th port. This eliminates the need for the surgeon to hold the light in one hand. Hence allows freeing of both hands for the surgeon to use a forceps in one hand to grasp and elevate membranes and a scissors in the other to cut connections between the retina and the membranes. When membranes are particularly thick, it can be difficult to dissect with a single forceps holding up the membrane. In this situation, a 5th port will be inserted allowing the assistant to insert a light source through one and a forceps though another. The surgeon will have a forceps in one hand and a scissors in another making dissection process more efficient.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraocular Assistance | Experimental | Procedure: Intraocular assistanceIntraocular assistance in patients undergoing standard of care vitreous surgeries |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent and authorization of use and disclosure of protected health information
- Age ≥18 years
- Subject will have complex retinal pathology for which it is judged that surgical objectives could be facilitated by VISIA
Key exclusion criteria (2 listed)
- Patients with disease processes such as macular pucker and macular hole that are generally well-managed by standard two-handed vitrectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraocular assistanceIntraocular assistance with help of surgical assistants during vitreous surgery (VISIA) in patients who require vitreous surgeries as part of standard of care procedure for conditions like retinal detachments, dislocated intraocular lens and glaucoma patients requiring endophotocoagulation. | Procedure or surgery | Intraocular Assistance |
Primary outcome
The primary outcome measure is recording of adverse events directly related to VISIA and adverse events unrelated to VISIA.
Time frame: 4 months
2 secondary outcomes
Surgeon's assessment of the benefits and risks of VISIA recorded on the surgical case report form.
Time frame: 4 months
Assistant's assessment of the benefits and risks of VISIA recorded on the surgical case report form.
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Difficulty in finding patients with complex retinal pathology to enroll in this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter A. Campochiaro, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular assistance in people with Traction Retinal Detachments and Rhegmatogenous Retinal Detachments, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty in finding patients with complex retinal pathology to enroll in this study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is recording of adverse events directly related to VISIA and adverse events unrelated to VISIA. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017.