Diabetes MellitusNCT00155454
Intravitreal Long Acting Gas in the Prevention of Early Postoperative Vitreous Hemorrhage in Diabetic Vitrectomy
A study testing Intravitreal long acting gas (10% C3F8) in people with Diabetes Mellitus and Diabetic Retinopathy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Recurrent vitreous hemorrhage after vitrectomy for complications of diabetic retinopathy is a common occurrence. The hemorrhage may appear within the first few weeks after surgery or months later. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Diabetic Retinopathy, Vitreous Hemorrhage
- What is being tested?
- Intravitreal long acting gas (10% C3F8)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2004to Dec 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients undergoing primary pars plana vitrectomy for complications of proliferative diabetic retinopathy were recruited for the prospective study
Who cannot join
- (1) anticoagulant therapy had been used prior to surgery or during post-operative follow-up period; (2) positive medical history of blood diseases associated with abnormal blood coagulation.
Trial locations and contacts
1 site in 1 country.
About this study
Recurrent vitreous hemorrhage after vitrectomy for complications of diabetic retinopathy is a common occurrence. The hemorrhage may appear within the first few weeks after surgery or months later. This complication may delay visual rehabilitation significantly and sometimes requires additional procedures or surgery, jeopardizing previous successful operation. The causes of bleeding are diverse. While evidence suggests fibrovascular proliferation from the sclerotomy sites or in the vitreous base may be an important source of recurrent vitreous hemorrhage, other origins of hemorrhage exist including lysed clot from residual vitreous skirt, injured retinal vessels from surgery, and incompletely removed fibrovascular tissues. The latter three conditions may be the major sources of early postoperative vitreous hemorrhage. We have shown that peripheral retinal cryotherapy along with cryo treatment at the sclerotomy sites may effectively reduce the incidence of fibrovascular proliferation at the inner surface of sclerotomy sites and prevent the late-onset recurrent vitreous hemorrhage. However, many patients still experience disturbing vitreous hemorrhage within the first two to three weeks after post-operative transient clear-up of the vitreous. We hypothesize that gas bubble within the vitreous cavity may mechanically temponade the fragile retinal vessels, and concentrate the coagulation factors in the vitreous cavity, allowing the integrity of vessel walls gradually recovers and thus preventing the occurrence of early postoperative recurrent vitreous hemorrhage.
To test this hypothesis, a clinical study was undertaken to investigate the effect of long-acting gas infused into the vitreous cavity at the end of diabetic vitrectomy in the prevention of recurrent vitreous hemorrhage.
Read the detailed description
The study consisted of two parts. Part one was prospective clinical observational study; part two was case control study.
From January 2005 to May 2005, consecutive patients undergoing primary pars plana vitrectomy for complications of proliferative diabetic retinopathy were recruited for the prospective study. The selection criteria were: 1) anticoagulant therapy should not have been used prior to surgery or during post-operative follow-up period; 2) ther should be no medical history of blood diseases associated with abnormal blood coagulation. During operation, removal of the fibrovascular tissues as well as old and fresh blood was attempted as completely as could be safely done in all cases; blood clots adherent to the peripheral vitreous skirt was removed as much as possible; peripheral retinal cryotherapy (10 to 12 spots in one row), and sclerotomy sites cryo (2 spots, each 6 seconds, for 3 sclerotomy sites) were performed. For those cases without retinal detachment and breaks, fluid-gas exchange with 7.5% C3F8 was done at the end of the surgery; For those with preexisting breaks or iatrogenic breaks induced retinal detachment, fluid-gas exchange with 15% C3F8 was performed before cryotherapy. After surgery, patients without breaks were kept in a prone position overnight, and maintained head down during waking hours and lied on either side, during sleep for 3 weeks. Other patients assumed head positions depending on the location of breaks. Ophthalmological examinations were performed in the first 4 days after surgery, then weekly for 6 weeks and then monthly for 4 months. The preoperative, intraoperative and postoperative data were collected for each patient. These included age, gender, study eye, types and duration of diabetes mellitus, intraoperative diagnosis, and the use of scleral buckle, silicone oil temponade; data regarding the time, duration, frequency and treatment of recurrent vitreous hemorrhage and the duration of post-operation follow-up were also compiled. Results of ophthalmological examinations, including best corrected visual acuity, intraocular pressures, corneal conditions, anterior chamber reactions, lens status, intravitreal gas amount, and retina conditions were recorded. The amount of vitreous blood was assessed by indirect ophthalmoscopy with patients in both sitting and face-up position. The degree of vitreous opacity was recorded according to criteria set for grading vitreous opacity in uveitis.
Patients who had silicone oil infusion, failed to achieve retinal attachment for at least 3 months, or followed for less than a minimum of 5-month were excluded from the study.
Using the same inclusion and exclusion criteria, chart review from September 2004 to May 2005 for diabetic cases operated by the same surgeon with only cryo treatment but without long-acting gas infusion at the end of vitrectomy was done. Similar data as for the prospective study (except intravitreal gas amount) were collected. These cases served as control to compare the rate of recurrent vitreous hemorrhage and the change of best-corrected visual acuity between cases with intravitreal long-acting gas and those without.
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy, Vitreous Hemorrhage
- Being tested
- Intravitreal long acting gas (10% C3F8)
- Keywords
- Diabetic retinopathy, Vitrectomy, Postoperative vitreous hemorrahge, Intravitreal gas injection
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy, Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal long acting gas (10% C3F8)Procedure or surgery
At the end of surgery, fluid-gas exchange with 10% C3F8 were done in the eye of study group
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Group 1 had intravitreal long acting gas (10% C3F8) injection in the vitreous cavity at the end of surgery Receives: Procedure: Intravitreal long acting gas (10% C3F8) |
| Control group | Sham comparator | Group 2 did not receive intravitreal long acting gas (10% C3F8) Receives: Procedure: Intravitreal long acting gas (10% C3F8) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent vitreous hemorrhage rate
Initial time to vitreous clearing , percentage of prolonged vitreous clearing, and early versus late manifest postoperative recurrent vitreous hemorrhage in groups 1 and 2 were compared to determine the effects of long acting gas on prevention of early recurrent vitreous hemorrhage.
Measured: Within 6 months after vitrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chung-May Yang, MD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155454
- Sponsor's protocol ID
- 9461700621
- Status last verified
- Dec 2012
- First submitted
- 8 Sep 2005
- Last updated
- 27 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Long Acting Gas in the Prevention of Early Postoperative Vitreous Hemorrhage in Diabetic Vitrectomy
- ClinicalTrials.gov ID
- NCT00155454
- Acronym / sponsor ID
- 9461700621
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy, Vitreous Hemorrhage
- Keywords
- Diabetic retinopathy, Vitrectomy, Postoperative vitreous hemorrahge, Intravitreal gas injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Sep 2005 (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.
Recurrent vitreous hemorrhage after vitrectomy for complications of diabetic retinopathy is a common occurrence. The hemorrhage may appear within the first few weeks after surgery or months later. This complication may delay visual rehabilitation significantly and sometimes requires additional procedures or surgery, jeopardizing previous successful operation. The causes of bleeding are diverse. While evidence suggests fibrovascular proliferation from the sclerotomy sites or in the vitreous base may be an important source of recurrent vitreous hemorrhage, other origins of hemorrhage exist including lysed clot from residual vitreous skirt, injured retinal vessels from surgery, and incompletely removed fibrovascular tissues. The latter three conditions may be the major sources of early postoperative vitreous hemorrhage. We have shown that peripheral retinal cryotherapy along with cryo treatment at the sclerotomy sites may effectively reduce the incidence of fibrovascular proliferation at the inner surface of sclerotomy sites and prevent the late-onset recurrent vitreous hemorrhage. However, many patients still experience disturbing vitreous hemorrhage within the first two to three weeks after post-operative transient clear-up of the vitreous. We hypothesize that gas bubble within the vitreous cavity may mechanically temponade the fragile retinal vessels, and concentrate the coagulation factors in the vitreous cavity, allowing the integrity of vessel walls gradually recovers and thus preventing the occurrence of early postoperative recurrent vitreous hemorrhage.
To test this hypothesis, a clinical study was undertaken to investigate the effect of long-acting gas infused into the vitreous cavity at the end of diabetic vitrectomy in the prevention of recurrent vitreous hemorrhage.
Detailed description
The study consisted of two parts. Part one was prospective clinical observational study; part two was case control study.
From January 2005 to May 2005, consecutive patients undergoing primary pars plana vitrectomy for complications of proliferative diabetic retinopathy were recruited for the prospective study. The selection criteria were: 1) anticoagulant therapy should not have been used prior to surgery or during post-operative follow-up period; 2) ther should be no medical history of blood diseases associated with abnormal blood coagulation. During operation, removal of the fibrovascular tissues as well as old and fresh blood was attempted as completely as could be safely done in all cases; blood clots adherent to the peripheral vitreous skirt was removed as much as possible; peripheral retinal cryotherapy (10 to 12 spots in one row), and sclerotomy sites cryo (2 spots, each 6 seconds, for 3 sclerotomy sites) were performed. For those cases without retinal detachment and breaks, fluid-gas exchange with 7.5% C3F8 was done at the end of the surgery; For those with preexisting breaks or iatrogenic breaks induced retinal detachment, fluid-gas exchange with 15% C3F8 was performed before cryotherapy. After surgery, patients without breaks were kept in a prone position overnight, and maintained head down during waking hours and lied on either side, during sleep for 3 weeks. Other patients assumed head positions depending on the location of breaks. Ophthalmological examinations were performed in the first 4 days after surgery, then weekly for 6 weeks and then monthly for 4 months. The preoperative, intraoperative and postoperative data were collected for each patient. These included age, gender, study eye, types and duration of diabetes mellitus, intraoperative diagnosis, and the use of scleral buckle, silicone oil temponade; data regarding the time, duration, frequency and treatment of recurrent vitreous hemorrhage and the duration of post-operation follow-up were also compiled. Results of ophthalmological examinations, including best corrected visual acuity, intraocular pressures, corneal conditions, anterior chamber reactions, lens status, intravitreal gas amount, and retina conditions were recorded. The amount of vitreous blood was assessed by indirect ophthalmoscopy with patients in both sitting and face-up position. The degree of vitreous opacity was recorded according to criteria set for grading vitreous opacity in uveitis.
Patients who had silicone oil infusion, failed to achieve retinal attachment for at least 3 months, or followed for less than a minimum of 5-month were excluded from the study.
Using the same inclusion and exclusion criteria, chart review from September 2004 to May 2005 for diabetic cases operated by the same surgeon with only cryo treatment but without long-acting gas infusion at the end of vitrectomy was done. Similar data as for the prospective study (except intravitreal gas amount) were collected. These cases served as control to compare the rate of recurrent vitreous hemorrhage and the change of best-corrected visual acuity between cases with intravitreal long-acting gas and those without.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Intravitreal long acting gas (10% C3F8)Group 1 had intravitreal long acting gas (10% C3F8) injection in the vitreous cavity at the end of surgery |
| Control group | Sham comparator | Procedure: Intravitreal long acting gas (10% C3F8)Group 2 did not receive intravitreal long acting gas (10% C3F8) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing primary pars plana vitrectomy for complications of proliferative diabetic retinopathy were recruited for the prospective study
Key exclusion criteria (1 listed)
- (1) anticoagulant therapy had been used prior to surgery or during post-operative follow-up period; (2) positive medical history of blood diseases associated with abnormal blood coagulation.
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 |
|---|---|---|
| Intravitreal long acting gas (10% C3F8)At the end of surgery, fluid-gas exchange with 10% C3F8 were done in the eye of study group | Procedure or surgery | Control group, Study group |
Primary outcome
Recurrent vitreous hemorrhage rate
Time frame: Within 6 months after vitrectomy
Initial time to vitreous clearing , percentage of prolonged vitreous clearing, and early versus late manifest postoperative recurrent vitreous hemorrhage in groups 1 and 2 were compared to determine the effects of long acting gas on prevention of early recurrent vitreous hemorrhage.
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 27 Dec 2012.
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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.
Chung-May Yang, MD study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravitreal long acting gas (10% C3F8) in people with Diabetes Mellitus and Diabetic Retinopathy, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 27 Dec 2012. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Recurrent vitreous hemorrhage rate (time frame: Within 6 months after vitrectomy). 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 27 Dec 2012.