Retinal DetachmentNCT01716507
23 Gauge and 20 Gauge Vitrectomy for Rhegmatogenous Retinal Detachments
A study testing Retinal Detachment repair in people with Retinal Detachment, run by Wills Eye at 1 site in United States.
Trial summary
This study is a comparison (23 gauge vs 20 gauge instrumentation) of surgical instrumentation for retinal detachment repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Retinal Detachment repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jul 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide written consent and comply with study assessments for the full duration of the study.
- Presence of retinal detachment with history of cataract surgery.
- Vision of hand motion or better.
Who cannot join
- Presence of a very large tear or type of retinal detachment usually a result of trauma.
- Prior eye surgery except for cataract surgery.
- Presence of significant scar tissue.
- Presence of retinal detachment due to hole in the macula.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Prospective, Randomized Study Comparing 23-gauge and 20-gauge Pars Plana Vitrectomy for Repair of Pseudophakic Rhegmatogenous Retinal Detachments
This study is a comparison (23 gauge vs 20 gauge instrumentation) of surgical instrumentation for retinal detachment repair.
Read the detailed description
The majority of studies on PPV for PRD up to this time have used 20-gauge instrumentation. Currently, both 23-gauge and 20-gauge instrumentation are commercially available for PPV. No studies have reported the efficacy of 23-gauge PPV compared to 20-gauge PPV for primary pseudophakic RRD. As a result, many retinal surgeons choose the modality based on personal preference.
- Conditions
- Retinal Detachment
- Being tested
- Retinal Detachment repair
- Keywords
- RRD, Rhegmatogenous, Retinal, Detachment, PPV, Pars Plana Vitrectomy, Gauge
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal Detachment repairProcedure or surgery
Comparing 23 gauge vs 20 gauge pars plana vitrectomy.
| Study group | Role | What they receive |
|---|---|---|
| 20 gauge pars plana vitrectomy | Other | 20 gauge pars plana vitrectomy for retinal detachment repair Receives: Procedure: Retinal Detachment repair |
| 23 gauge pars plana vitrectomy | Other | 23 gauge pars plana vitrectomy for retinal detachment repair Receives: Procedure: Retinal Detachment repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the initial retinal reattachment rates by comparing the percentages/amount.
Measured: 1 Year
Secondary outcomes (3)
Change in best-corrected visual acuity by comparing letters read.
To determine the change in best-corrected visual acuity (BCVA) at the pre-operative visit compared to the 6 month post-operative visit
Measured: 6 months
Reattachment rates with 23 gauge and 20 gauge PPV by comparing the amount.
To determine the final retinal reattachment rates with 23-gauge and 20-gauge PPV if multiple surgeries are required.
Measured: 1 year
Operating time for 23 gauge versus 20 gauge PPV (time measurement)
This will be done to determine operating times for 23-gauge versus 20-gauge PPV for primary repair of PRD.
Measured: 1 day- Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startApr 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Hsu, MD, Principal investigator, Wills Eye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716507
- Sponsor's protocol ID
- 23VS20RD
- Other IDs
- IRB08858
- Status last verified
- Dec 2016
- First submitted
- 25 Oct 2012
- Last updated
- 12 Dec 2016
- 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 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study Comparing 23-gauge and 20-gauge Pars Plana Vitrectomy for Repair of Pseudophakic Rhegmatogenous Retinal Detachments
- ClinicalTrials.gov ID
- NCT01716507
- Acronym / sponsor ID
- 23VS20RD
- Conditions
- Retinal Detachment
- Keywords
- RRD, Rhegmatogenous, Retinal, Detachment, PPV, Pars Plana Vitrectomy, Gauge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 29 Oct 2012 (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.
This study is a comparison (23 gauge vs 20 gauge instrumentation) of surgical instrumentation for retinal detachment repair.
Detailed description
The majority of studies on PPV for PRD up to this time have used 20-gauge instrumentation. Currently, both 23-gauge and 20-gauge instrumentation are commercially available for PPV. No studies have reported the efficacy of 23-gauge PPV compared to 20-gauge PPV for primary pseudophakic RRD. As a result, many retinal surgeons choose the modality based on personal preference.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 gauge pars plana vitrectomy | Other | Procedure: Retinal Detachment repair20 gauge pars plana vitrectomy for retinal detachment repair |
| 23 gauge pars plana vitrectomy | Other | Procedure: Retinal Detachment repair23 gauge pars plana vitrectomy for retinal detachment repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to provide written consent and comply with study assessments for the full duration of the study.
- Presence of retinal detachment with history of cataract surgery.
- Vision of hand motion or better.
Key exclusion criteria (4 listed)
- Presence of a very large tear or type of retinal detachment usually a result of trauma.
- Prior eye surgery except for cataract surgery.
- Presence of significant scar tissue.
- Presence of retinal detachment due to hole in the macula.
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 |
|---|---|---|
| Retinal Detachment repairComparing 23 gauge vs 20 gauge pars plana vitrectomy. | Procedure or surgery | 20 gauge pars plana vitrectomy, 23 gauge pars plana vitrectomy |
Primary outcome
Assess the initial retinal reattachment rates by comparing the percentages/amount.
Time frame: 1 Year
3 secondary outcomes
Change in best-corrected visual acuity by comparing letters read.
Time frame: 6 months
Reattachment rates with 23 gauge and 20 gauge PPV by comparing the amount.
Time frame: 1 year
Operating time for 23 gauge versus 20 gauge PPV (time measurement)
Time frame: 1 day- Day of 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 12 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Retinal Detachment
RecruitingPhase 2
Prevention of ProliFerative Vitreoretinopathy With Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Recruiting
Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Stickler Syndrome Type 1, Stickler Syndrome Type 2
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
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.
Jason Hsu, MD principal investigator
Wills Eye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retinal Detachment repair in people with Retinal Detachment, run by Wills Eye 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 3 inclusion and 4 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 12 Dec 2016. 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?
Assess the initial retinal reattachment rates by comparing the percentages/amount. (time frame: 1 Year). 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 12 Dec 2016.