Visual AcuityPhase 3TSV-25GNCT00870597
Transconjunctival Sutureless 25-Gauge Vitrectomy
A Phase 3 study testing Multifocal IOL implantation + Vitrectomy and Multifocal IOL implantation - Vitrectomy in people with Visual Acuity, run by Hospital Oftalmologico de Brasilia at 1 site in Brazil.
Trial summary
The aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal intraocular lens (IOL) implantation. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Visual Acuity
- What is being tested?
- Multifocal IOL implantation + Vitrectomy and Multifocal IOL implantation - Vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2007to Dec 2008
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- disabling vitreous floaters
- Age-related cataract Unsatisfactory correction with glasses
Who cannot join
- central endothelial cell count less than 2000 cells/mm2
- glaucoma or intraocular pressure greater than 21 mmHg
- amblyopia
- retinal abnormalities
- diabetes mellitus
- steroid or immunosuppressive treatment
- connective tissue diseases
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Oftalmologico de Brasilia
Brasília, Federal District, 70000
About this study
Official title: Transconjunctival Sutureless 25-Gauge Vitrectomy for Visually Significant Vitreous Floaters in Patients With Multifocal Intraocular Lens
The aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal intraocular lens (IOL) implantation.
Read the detailed description
Purpose: The aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal intraocular lens (IOL) implantation.
Setting: Hospital Oftalmológico de Brasília, Brasília, DF, Brazil.
Methods: Fourteen eyes of 11 patients with multifocal IOL implant associated with vitreous opacities that underwent 25-gauge vitrectomy were prospectively analyzed. Information collected included near and distance uncorrected visual acuity (UCDVA), best corrected distance visual acuity (BCDVA), and the spherical equivalent (SE) before and 3 months after vitrectomy. Patients were questioned about surgery satisfaction and visual improvement after vitrectomy.
- Conditions
- Visual Acuity
- Being tested
- Multifocal IOL implantation + Vitrectomy, Multifocal IOL implantation - Vitrectomy
- Keywords
- Floaters, multifocal IOL, visual complaints, vitrectomy
- Medical subject headings
- vitreous floaters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifocal IOL implantation + VitrectomyProcedure or surgery
Also called VITRECTOMY
25-gauge transconjuntival sutureless vitrectomy (TSV)
Multifocal IOL implantation - VitrectomyProcedure or surgery
Multifocal IOL implantation without transconjunctival vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Multifocal IOL implant associated with vitreous opacities that underwent 25-gauge vitrectomy were prospectively analyzed. Receives: Procedure: Multifocal IOL implantation + Vitrectomy |
| 2 | Experimental | Multifocal IOL implantation without transconjunctival vitrectomy Receives: Procedure: Multifocal IOL implantation - Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal intraocular lens (IOL) implantation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startJan 2007
- Primary completionFeb 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual AcuityStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Oftalmologico de Brasilia
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Minas Gerais
- Investigators
- PATRICK TZELIKIS, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870597
- Sponsor's protocol ID
- HOB-03
- Acronym
- TSV-25G
- Status last verified
- Mar 2009
- First submitted
- 26 Mar 2009
- Last updated
- 27 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transconjunctival Sutureless 25-Gauge Vitrectomy for Visually Significant Vitreous Floaters in Patients With Multifocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT00870597
- Acronym / sponsor ID
- TSV-25G / HOB-03
- Conditions
- Visual Acuity
- Keywords
- Floaters, multifocal IOL, visual complaints, vitrectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hospital Oftalmologico de BrasiliaUniversity, hospital or other
- Collaborators
- Federal University of Minas Gerais
- Study start
- Jan 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 27 Mar 2009 (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 aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal intraocular lens (IOL) implantation.
Detailed description
Purpose: The aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal intraocular lens (IOL) implantation.
Setting: Hospital Oftalmológico de Brasília, Brasília, DF, Brazil.
Methods: Fourteen eyes of 11 patients with multifocal IOL implant associated with vitreous opacities that underwent 25-gauge vitrectomy were prospectively analyzed. Information collected included near and distance uncorrected visual acuity (UCDVA), best corrected distance visual acuity (BCDVA), and the spherical equivalent (SE) before and 3 months after vitrectomy. Patients were questioned about surgery satisfaction and visual improvement after vitrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Multifocal IOL implantation + VitrectomyMultifocal IOL implant associated with vitreous opacities that underwent 25-gauge vitrectomy were prospectively analyzed. |
| 2 | Experimental | Procedure: Multifocal IOL implantation - VitrectomyMultifocal IOL implantation without transconjunctival vitrectomy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- disabling vitreous floaters
- Age-related cataract Unsatisfactory correction with glasses
Key exclusion criteria (7 listed)
- central endothelial cell count less than 2000 cells/mm2
- glaucoma or intraocular pressure greater than 21 mmHg
- amblyopia
- retinal abnormalities
- diabetes mellitus
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 |
|---|---|---|
| Multifocal IOL implantation + VitrectomyAlso: VITRECTOMY25-gauge transconjuntival sutureless vitrectomy (TSV) | Procedure or surgery | 1 |
| Multifocal IOL implantation - VitrectomyMultifocal IOL implantation without transconjunctival vitrectomy | Procedure or surgery | 2 |
Primary outcome
The aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal intraocular lens (IOL) implantation
Time frame: 1 year
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 Mar 2009.
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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.
PATRICK TZELIKIS, PhD principal investigator
Federal University of Minas Gerais
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 Multifocal IOL implantation + Vitrectomy and Multifocal IOL implantation - Vitrectomy in people with Visual Acuity, run by Hospital Oftalmologico de Brasilia at 1 site in 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 2 inclusion and 7 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 Mar 2009. 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 Brazil. 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?
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 aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal intraocular lens (IOL) implantation (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 27 Mar 2009; AzTrials last refreshed its copy on 28 Oct 2026.