Pseudophakic Retinal DetachmentPhase 3NCT00370279
Surgical Management of Pseudophakic and Aphakic Retinal Detachment; a Randomized Clinical Trial
A Phase 3 study testing scleral buckling, primary vitrectomy in people with Pseudophakic Retinal Detachment and Aphakic Retinal Detachment, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
To compare the visual and anatomical outcomes and complications of four surgical techniques (1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy) for management of pseudophakic and aphakic retinal detachment Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pseudophakic Retinal Detachment, Aphakic Retinal Detachment
- What is being tested?
- scleral buckling, primary vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Sep 2005to not given
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cases of pseudophakic and aphakic retinal detachment with PVR grade A or B
Who cannot join
- PVR grade C
- History of surgery for RD
- Signs of diabetic retinopathy, AMD, glaucoma and macular hole
- History of ocular trauma
- Giant retinal tear
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Hamid Ahmadieh, MD
Tehran, Tehran Province, 16666
Hamid Ahmadieh, MD, +98 21 22585952, hahmadieh@hotmail.com
About this study
To compare the visual and anatomical outcomes and complications of four surgical techniques (1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy) for management of pseudophakic and aphakic retinal detachment
- Being tested
- scleral buckling, primary vitrectomy
- Keywords
- Pseudophakic retinal detachment,, Aphakic retinal detachment,, Scleral buckling,, Primary vitrectomy,, Proliferative vitreoretinopathy
- Medical subject headings
- Vitreoretinopathy, Proliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scleral buckling, primary vitrectomyProcedure or surgery
Four different surgical techniques were performed(one in each arm); 1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | scleral buckling Receives: Procedure: scleral buckling, primary vitrectomy |
| 2 | Active comparator | Primary vitrectomy without encircling band Receives: Procedure: scleral buckling, primary vitrectomy |
| 3 | Active comparator | Primary vitrectomy with encircling band Receives: Procedure: scleral buckling, primary vitrectomy |
| 4 | Active comparator | Triamcinolone assisted vitrectomy Receives: Procedure: scleral buckling, primary vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal reattachment rate
Visual acuity
Secondary outcomes (5)
Proliferative vitreoretinopathy
Macular Pucker
Anisometropia
Choroidal detachment
Reoperation
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 startSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudophakic 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
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Hamid Ahmadieh, MD, Principal investigator, Ophthalmic Research Center of Shaheed Beheshti Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370279
- Sponsor's protocol ID
- 8405
- Status last verified
- Jun 2008
- First submitted
- 30 Aug 2006
- Last updated
- 26 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Management of Pseudophakic and Aphakic Retinal Detachment; a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00370279
- Acronym / sponsor ID
- 8405
- Keywords
- Pseudophakic retinal detachment,, Aphakic retinal detachment,, Scleral buckling,, Primary vitrectomy,, Proliferative vitreoretinopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2005
- 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.
To compare the visual and anatomical outcomes and complications of four surgical techniques (1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy) for management of pseudophakic and aphakic retinal detachment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: scleral buckling, primary vitrectomyscleral buckling |
| 2 | Active comparator | Procedure: scleral buckling, primary vitrectomyPrimary vitrectomy without encircling band |
| 3 | Active comparator | Procedure: scleral buckling, primary vitrectomyPrimary vitrectomy with encircling band |
| 4 | Active comparator | Procedure: scleral buckling, primary vitrectomyTriamcinolone assisted vitrectomy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cases of pseudophakic and aphakic retinal detachment with PVR grade A or B
Key exclusion criteria (5 listed)
- PVR grade C
- History of surgery for RD
- Signs of diabetic retinopathy, AMD, glaucoma and macular hole
- History of ocular trauma
- Giant retinal tear
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 |
|---|---|---|
| scleral buckling, primary vitrectomyFour different surgical techniques were performed(one in each arm); 1- scleral buckling, 2- primary vitrectomy without encircling band, 3- primary vitrectomy with encircling band, 4- triamcinolone assisted vitrectomy | Procedure or surgery | 1, 2, 3, 4 |
Primary outcome
Retinal reattachment rate
Visual acuity
5 secondary outcomes
Proliferative vitreoretinopathy
Macular Pucker
Anisometropia
Choroidal detachment
Reoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 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.
Hamid Ahmadieh, 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 Phase 3 study testing scleral buckling, primary vitrectomy in people with Pseudophakic Retinal Detachment and Aphakic Retinal Detachment, 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: status not confirmed, as of the sponsor's last update on 26 Jun 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hamid Ahmadieh, MD (+98 21 22585952, hahmadieh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal reattachment rate. The study lists 2 primary outcomes in all. 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 26 Jun 2008.