Late Postvitrectomy Diabetic Hemorrhage.NCT00370409
Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage
A study testing Cryotherapy in people with Late Postvitrectomy Diabetic Hemorrhage., run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Late vitreous hemorrhage in postvitrectomized diabetic eyes may be due to fibrovascular tuft formation in sclerotomy sites. Cryotherapy of sclerotomy sites may prevent bleeding by regressing the fibrovascular tuft. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Late Postvitrectomy Diabetic Hemorrhage.
- What is being tested?
- Cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteIran
- Study dates
- Jan 2006to Jun 2008
- 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
- Diabetic retinopathy cases undergoing vitrectomy
Who cannot join
- History of deep vitrectomy or cataract surgery
- Renal failure
- Silicone oil injection during surgery
- Early rebleeding
- History of antithrombotic drugs usage
Trial locations and contacts
1 site in 1 country.
About this study
Late vitreous hemorrhage in postvitrectomized diabetic eyes may be due to fibrovascular tuft formation in sclerotomy sites. Cryotherapy of sclerotomy sites may prevent bleeding by regressing the fibrovascular tuft. This study will detect the safety and efficacy of cryotherapy of sclerotomy sites for prevention of late vitreous hemorrhage in vitrectomized diabetic eyes.
- Conditions
- Late Postvitrectomy Diabetic Hemorrhage.
- Being tested
- Cryotherapy
- Keywords
- Rebleeding, Diabetic vitreous hemorrhage, Cryotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyProcedure or surgery
Cryotherapy of both sides of sclerotomy sites was done for 6 seconds after complition of operation.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cryotherapy Receives: Procedure: Cryotherapy |
| 2 | Placebo comparator | Not described Receives: Procedure: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes
Measured: 6 months
Secondary outcomes (3)
Incidence of late vitreous hemorrhage in the cryo group.
Measured: 6 months
Incidence of late vitreous hemorrhage in the control group.
Measured: 6 months
Comparing incidence of late vitreous hemorrhage in both groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2006 (estimated)
- Study startJan 2006
- Primary completionFeb 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Postvitrectomy Diabetic Hemorrhage.Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Morteza Entezari, MD, Principal investigator, Ophthalmic Research Center of Shaheed Beheshti Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370409
- Sponsor's protocol ID
- 8525
- Status last verified
- Jul 2008
- First submitted
- 30 Aug 2006
- Last updated
- 1 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage
- ClinicalTrials.gov ID
- NCT00370409
- Acronym / sponsor ID
- 8525
- Conditions
- Late Postvitrectomy Diabetic Hemorrhage.
- Keywords
- Rebleeding, Diabetic vitreous hemorrhage, Cryotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 31 Aug 2006 (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.
Late vitreous hemorrhage in postvitrectomized diabetic eyes may be due to fibrovascular tuft formation in sclerotomy sites. Cryotherapy of sclerotomy sites may prevent bleeding by regressing the fibrovascular tuft. This study will detect the safety and efficacy of cryotherapy of sclerotomy sites for prevention of late vitreous hemorrhage in vitrectomized diabetic eyes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: CryotherapyCryotherapy |
| 2 | Placebo comparator | Procedure: Cryotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic retinopathy cases undergoing vitrectomy
Key exclusion criteria (5 listed)
- History of deep vitrectomy or cataract surgery
- Renal failure
- Silicone oil injection during surgery
- Early rebleeding
- History of antithrombotic drugs usage
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 |
|---|---|---|
| CryotherapyCryotherapy of both sides of sclerotomy sites was done for 6 seconds after complition of operation. | Procedure or surgery | 1, 2 |
Primary outcome
Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes
Time frame: 6 months
3 secondary outcomes
Incidence of late vitreous hemorrhage in the cryo group.
Time frame: 6 months
Incidence of late vitreous hemorrhage in the control group.
Time frame: 6 months
Comparing incidence of late vitreous hemorrhage in both groups.
Time frame: 6 months
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 1 Aug 2008.
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.
Morteza Entezari, MD principal investigator
Ophthalmic Research Center of Shaheed Beheshti Medical 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 Cryotherapy in people with Late Postvitrectomy Diabetic Hemorrhage., run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 5 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 1 Aug 2008. 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 Iran. 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?
Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes (time frame: 6 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 1 Aug 2008.