Rhegmatogenous Retinal DetachmentPhase 3NCT01068379
Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation
A Phase 3 study testing criopexy and laser in people with Rhegmatogenous Retinal Detachment, run by University of Campinas, Brazil.
Trial summary
The purpose of this randomized clinical trial was to compare reattachment rates among patients with rhegmatogenous retinal detachment who underwent scleral buckle surgery with retinopexy by cryotherapy versus postoperative (one month) laser photocoagulation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rhegmatogenous Retinal Detachment
- What is being tested?
- criopexy and laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Jan 2009
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Primary rhegmatogenous retinal detachment with a single peripherical retinal break. All patients were phakic, under eighteen years old, with partial posterior vitreous detachment, visual loss or symptoms (floaters and photopsia) less than 30 days
Who cannot join
- No patient had a retinal break greater than 30 degrees, or retinal detachment larger than two quadrants, history of uveitis or infectious retinopathy, presence of Proliferative vitreoretinopathy (B or C), macular disease, glaucoma, hemoglobinopathy, diabetic retinopathy, and history of trauma or previous vitreoretinal surgery.
About this study
Official title: Randomized Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation for Retinopexy in Scleral Buckle Surgery
The purpose of this randomized clinical trial was to compare reattachment rates among patients with rhegmatogenous retinal detachment who underwent scleral buckle surgery with retinopexy by cryotherapy versus postoperative (one month) laser photocoagulation.
Read the detailed description
The purpose of this randomized clinical trial was to compare reattachment rates, visual acuity results and epiretinal membrane formation among patients with rhegmatogenous retinal detachment who underwent scleral buckle surgery with retinopexy by cryotherapy versus postoperative (one month) laser photocoagulation.
- Conditions
- Rhegmatogenous Retinal Detachment
- Being tested
- criopexy, laser
- Keywords
- rhegmatogenous retinal detachment, cryopexy, photocoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
criopexyProcedure or surgery
he cryopexy was performed by placement of a normal spherical probe under the bucklings, around the break. The number of cryo applications was limited in number of 3. Freezing was stopped at the beginning of retinal whitening.
laserProcedure or surgery
Laser-retinopexy was performed after proper positioning the patients; laser energy was delivered by depressing a foot pedal. Short burn duration (0.1 seconds) and low (300-miliWatts) power settings were used initially, and both the burn duration and power were gradually increased as determined by observation.
| Study group | Role | What they receive |
|---|---|---|
| Cryopexy | Experimental | the cryopexy was performed by placement of a normal spherical probe under the bucklings, around the break. The number of cryo applications was limited in number of 3. Freezing was stopped at the beginning of retinal whitening. Receives: Procedure: criopexy |
| laser photocoagulation 4 weeks after | Experimental | Laser-retinopexy was performed after proper positioning the patients; laser energy was delivered by depressing a foot pedal. Short burn duration (0.1 seconds) and low (300-miliWatts) power settings were used initially, and both the burn duration and power were gradually increased as determined by observation. Receives: Procedure: laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was one week reattachment rate
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startJul 2006
- Primary completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rhegmatogenous 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068379
- Sponsor's protocol ID
- cryo laser
- Status last verified
- May 2010
- First submitted
- 11 Feb 2010
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lira RP, Takasaka I, Arieta CE, Nascimento MA, Caldato R, Panetta H. Cryotherapy vs laser photocoagulation in scleral buckle surgery: A randomized clinical trial. Arch Ophthalmol. 2010 Dec;128(12):1519-22. doi: 10.1001/archophthalmol.2010.271.
PubMed 21149772
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation for Retinopexy in Scleral Buckle Surgery
- ClinicalTrials.gov ID
- NCT01068379
- Acronym / sponsor ID
- cryo laser
- Conditions
- Rhegmatogenous Retinal Detachment
- Keywords
- rhegmatogenous retinal detachment, cryopexy, photocoagulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jan 2009 (actual)
- First posted
- 12 Feb 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.
The purpose of this randomized clinical trial was to compare reattachment rates among patients with rhegmatogenous retinal detachment who underwent scleral buckle surgery with retinopexy by cryotherapy versus postoperative (one month) laser photocoagulation.
Detailed description
The purpose of this randomized clinical trial was to compare reattachment rates, visual acuity results and epiretinal membrane formation among patients with rhegmatogenous retinal detachment who underwent scleral buckle surgery with retinopexy by cryotherapy versus postoperative (one month) laser photocoagulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryopexy | Experimental | Procedure: criopexythe cryopexy was performed by placement of a normal spherical probe under the bucklings, around the break. The number of cryo applications was limited in number of 3. Freezing was stopped at the beginning of retinal whitening. |
| laser photocoagulation 4 weeks after | Experimental | Procedure: laserLaser-retinopexy was performed after proper positioning the patients; laser energy was delivered by depressing a foot pedal. Short burn duration (0.1 seconds) and low (300-miliWatts) power settings were used initially, and both the burn duration and power were gradually increased as determined by observation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary rhegmatogenous retinal detachment with a single peripherical retinal break. All patients were phakic, under eighteen years old, with partial posterior vitreous detachment, visual loss or symptoms (floaters and photopsia) less than 30 days
Key exclusion criteria (1 listed)
- No patient had a retinal break greater than 30 degrees, or retinal detachment larger than two quadrants, history of uveitis or infectious retinopathy, presence of Proliferative vitreoretinopathy (B or C), macular disease, glaucoma, hemoglobinopathy, diabetic retinopathy, and history of trauma or previous vitreoretinal surgery.
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 |
|---|---|---|
| criopexyhe cryopexy was performed by placement of a normal spherical probe under the bucklings, around the break. The number of cryo applications was limited in number of 3. Freezing was stopped at the beginning of retinal whitening. | Procedure or surgery | Cryopexy |
| laserLaser-retinopexy was performed after proper positioning the patients; laser energy was delivered by depressing a foot pedal. Short burn duration (0.1 seconds) and low (300-miliWatts) power settings were used initially, and both the burn duration and power were gradually increased as determined by observation. | Procedure or surgery | laser photocoagulation 4 weeks after |
Primary outcome
The primary outcome was one week reattachment rate
Time frame: 1 week
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 26 May 2010.
- Derived from this study: PubMed 21149772Lira RP, Takasaka I, Arieta CE, Nascimento MA, Caldato R, Panetta H. Cryotherapy vs laser photocoagulation in scleral buckle surgery: A randomized clinical trial. Arch Ophthalmol. 2010 Dec;128(12):1519-22. doi: 10.1001/archophthalmol.2010.271.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing criopexy and laser in people with Rhegmatogenous Retinal Detachment, run by University of Campinas, Brazil.
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 26 May 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary outcome was one week reattachment rate (time frame: 1 week). 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 NCT01068379, which also lists 1 linked publication.
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 May 2010.