GlaucomaPROVENCT01162356
Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) Study
An observational study of Glaucoma and Macular Pucker, run by Vanderbilt University at 1 site in United States.
Trial summary
Since the introduction of vitrectomy in 1971, this procedure has become the third most frequently performed ophthalmic surgery. Approximately 225,000 vitrectomies are performed annually in the United States and indications continue to expand. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Macular Pucker, Macula Hole
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to 24 Jan 2017
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients presenting to ophthalmology practice requiring pars plana vitrectomy
Who may be able to join
- Able to consent and comply for the duration of the study and imaging studies
- Media clarity sufficient for imaging studies
- No previous treatment or surgery that might confound study results in the study or fellow eye
- Pars plana vitrectomy (PPV) indicated for epiretinal membrane (ERM), macular hole (MH), vitreo-macular traction (VMT), and vitreous hemorrhage (VH)
Who cannot join
- Unable to consent and/or comply for the duration of the study and imaging studies
- History of the following conditions: Glaucoma or associated conditions, visual field defects, uveitis, age-related macular degeneration (ARMD), prior PPV for retinal detachment, retained lens or dislocated intraocular lens
- Contralateral eye status post PPV or with advanced eye disease serious enough to warrant future PPV - Contralateral eye with condition that may result in choroidal neovascular membrane
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Eye Institute
Nashville, Tennessee, 37203
About this study
Official title: A Prospective Analysis of Nerve Fiber Layer and Macular Changes After Pars Plana Vitrectomy
Since the introduction of vitrectomy in 1971, this procedure has become the third most frequently performed ophthalmic surgery. Approximately 225,000 vitrectomies are performed annually in the United States and indications continue to expand. Known long-term complications of vitrectomy are relatively few and include retinal detachment and cataract formation. Although much has been written in the literature concerning acute rises in intraocular pressure (IOP) in the immediate postoperative period, there is surprisingly little information on long term IOP outcomes after vitrectomy. A recent report by Chang given at the LXII (62) Edward Jackson Memorial Lecture hypothesized a causal relationship between vitrectomy and open-angle glaucoma (OAG) via oxidative stress exacerbated by removal of the crystalline lens. A second report by Luk and colleagues reported similar conclusions in a modified cohort. Both studies, were retrospective in nature and did not perform baseline evaluations to exclude pre-existing glaucoma. Furthermore neither study accounted for natural history. Finally, our analysis has not reproduced similar results.
The primary purpose of this study is to analyze the full spectrum of optic nerve and macular changes between vitrectomized study eyes and their non-vitrectomized fellow eyes to control for natural history. Baseline evaluations will include examination by fellowship trained retina and glaucoma specialists, fundus photography, autofluorescence, optical coherence tomography (macula and optic nerve) and automated visual field testing. At 3 month then annually for 5 years after vitrectomy surgery, the cohort will undergo similar evaluation.
- Conditions
- Glaucoma, Macular Pucker, Macula Hole, Vitreomacular Traction, Vitreous Opacities or Hemorrhage
- Keywords
- Vitrectomy, Glaucoma, Macula, Optic nerve, Ocular Coherence Tomography
- Medical subject headings
- Glaucoma, Epiretinal Membrane, Retinal Perforations, vitreous floaters, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve fiber layer and macular changes after vitrectomy
To determine the incidence of nerve fiber layer (NFL) and macular changes after pars plana vitrectomy, characterize their extent and quality, and determine pre-disposing risk factors.
Measured: 3 month and annually for 5 years after surgery
Secondary outcomes (2)
Visual field defects
To characterize long-term functional consequences of NFL or macular changes with regards to peripheral and central visual field defects after PPV.
Measured: 3 month and annually for 5 years after surgery
Open-angle glaucoma
To determine the incidence of elevated intraocular pressure and open-angle glaucoma following vitrectomy. Enrolled patients will be screened at baseline to exclude pre-existing glaucoma and post-operative glaucoma screenings will be performed by fellowship trained glaucoma specialist.
Measured: 3 month and annually for 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startJul 2010
- Primary completion24 Jan 2017
- Study completion24 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen J. Kim, MD, Vanderbilt University
- Investigators
- Stephen J Kim, MD, Principal investigator, Vanderbilt Eye InstituteMaziar Lalezary, MD, Study director, Vanderbilt Eye InstituteRahul K Reddy, MD, Study director, Vanderbilt Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162356
- Sponsor's protocol ID
- 100073
- Acronym
- PROVE
- Status last verified
- Feb 2017
- First submitted
- 12 Jul 2010
- Last updated
- 23 Feb 2017
- Results posted
- No
Publications
Machemer R, Buettner H, Norton EW, Parel JM. Vitrectomy: a pars plana approach. Trans Am Acad Ophthalmol Otolaryngol. 1971 Jul-Aug;75(4):813-20. No abstract available.
PubMed 5566980Chang S. LXII Edward Jackson lecture: open angle glaucoma after vitrectomy. Am J Ophthalmol. 2006 Jun;141(6):1033-1043. doi: 10.1016/j.ajo.2006.02.014.
PubMed 16765671Luk FO, Kwok AK, Lai TY, Lam DS. Presence of crystalline lens as a protective factor for the late development of open angle glaucoma after vitrectomy. Retina. 2009 Feb;29(2):218-24. doi: 10.1097/IAE.0b013e31818ba9ca.
PubMed 18936722
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis of Nerve Fiber Layer and Macular Changes After Pars Plana Vitrectomy
- ClinicalTrials.gov ID
- NCT01162356
- Acronym / sponsor ID
- PROVE / 100073
- Conditions
- Glaucoma, Macular Pucker, Macula Hole, Vitreomacular Traction, Vitreous Opacities or Hemorrhage
- Keywords
- Vitrectomy, Glaucoma, Macula, Optic nerve, Ocular Coherence Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- 24 Jan 2017 (actual)
- Study completion
- 24 Jan 2017 (actual)
- First posted
- 14 Jul 2010 (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.
Since the introduction of vitrectomy in 1971, this procedure has become the third most frequently performed ophthalmic surgery. Approximately 225,000 vitrectomies are performed annually in the United States and indications continue to expand. Known long-term complications of vitrectomy are relatively few and include retinal detachment and cataract formation. Although much has been written in the literature concerning acute rises in intraocular pressure (IOP) in the immediate postoperative period, there is surprisingly little information on long term IOP outcomes after vitrectomy. A recent report by Chang given at the LXII (62) Edward Jackson Memorial Lecture hypothesized a causal relationship between vitrectomy and open-angle glaucoma (OAG) via oxidative stress exacerbated by removal of the crystalline lens. A second report by Luk and colleagues reported similar conclusions in a modified cohort. Both studies, were retrospective in nature and did not perform baseline evaluations to exclude pre-existing glaucoma. Furthermore neither study accounted for natural history. Finally, our analysis has not reproduced similar results.
The primary purpose of this study is to analyze the full spectrum of optic nerve and macular changes between vitrectomized study eyes and their non-vitrectomized fellow eyes to control for natural history. Baseline evaluations will include examination by fellowship trained retina and glaucoma specialists, fundus photography, autofluorescence, optical coherence tomography (macula and optic nerve) and automated visual field testing. At 3 month then annually for 5 years after vitrectomy surgery, the cohort will undergo similar evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting to ophthalmology practice requiring pars plana vitrectomy
Key inclusion criteria (4 listed)
- Able to consent and comply for the duration of the study and imaging studies
- Media clarity sufficient for imaging studies
- No previous treatment or surgery that might confound study results in the study or fellow eye
- Pars plana vitrectomy (PPV) indicated for epiretinal membrane (ERM), macular hole (MH), vitreo-macular traction (VMT), and vitreous hemorrhage (VH)
Key exclusion criteria (3 listed)
- Unable to consent and/or comply for the duration of the study and imaging studies
- History of the following conditions: Glaucoma or associated conditions, visual field defects, uveitis, age-related macular degeneration (ARMD), prior PPV for retinal detachment, retained lens or dislocated intraocular lens
- Contralateral eye status post PPV or with advanced eye disease serious enough to warrant future PPV - Contralateral eye with condition that may result in choroidal neovascular membrane
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nerve fiber layer and macular changes after vitrectomy
Time frame: 3 month and annually for 5 years after surgery
To determine the incidence of nerve fiber layer (NFL) and macular changes after pars plana vitrectomy, characterize their extent and quality, and determine pre-disposing risk factors.
2 secondary outcomes
Visual field defects
Time frame: 3 month and annually for 5 years after surgery
Open-angle glaucoma
Time frame: 3 month and annually for 5 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Background: PubMed 5566980Machemer R, Buettner H, Norton EW, Parel JM. Vitrectomy: a pars plana approach. Trans Am Acad Ophthalmol Otolaryngol. 1971 Jul-Aug;75(4):813-20. No abstract available.
- Background: PubMed 16765671Chang S. LXII Edward Jackson lecture: open angle glaucoma after vitrectomy. Am J Ophthalmol. 2006 Jun;141(6):1033-1043. doi: 10.1016/j.ajo.2006.02.014.
- Background: PubMed 18936722Luk FO, Kwok AK, Lai TY, Lam DS. Presence of crystalline lens as a protective factor for the late development of open angle glaucoma after vitrectomy. Retina. 2009 Feb;29(2):218-24. doi: 10.1097/IAE.0b013e31818ba9ca.
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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.
Stephen J Kim, MD principal investigator
Vanderbilt Eye Institute
Maziar Lalezary, MD study director
Vanderbilt Eye Institute
Rahul K Reddy, MD study director
Vanderbilt Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Macular Pucker, run by Vanderbilt 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 3 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: finished, as of the sponsor's last update on 23 Feb 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nerve fiber layer and macular changes after vitrectomy (time frame: 3 month and annually for 5 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01162356, which also lists 3 linked publications.
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 23 Feb 2017.