VitrectomyNCT01176331
Outcomes of 20 and 23-gauge Combined Transconjunctival Pars Plana Vitrectomy
An observational study of Vitrectomy, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
In a retrospective study, a combined 20 and 23-gauge pars plana vitrectomy procedure was performed in 21 eyes for various indications and proposed as a transition procedure to 23-gauge transconjunctival vitrectomy. Read more about this study
- Who is it for?
- Ages 44 to 80 years
- Conditions the study is for
- Vitrectomy
- What is being tested?
- 20 and 23 gauge pars plana vitrectomy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 44 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients who were in the range 44 to 80 years, who had to undergo vitrectomy operation with different diagnosis were included in the study. Each participant had a complete ophthalmological examination which included best-corrected visual acuity (BCVA), slit lamp examination with and without pupil dilation, intraocular pressure (IOP) measurement with applanation tonometry and stereoscopic evaluation of the ocular fundus before decision of operation.
Who may be able to join
- eyes requiring pars plana vitrectomy for various indications: such as dropped lens, intraocular blood, retinal detachments...etc.
Who cannot join
- patients who did not observed periodically during postoperative period.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of ophthalmology,Hospital of Faculty of Medicine, Kocaeli University
Kocaeli
About this study
In a retrospective study, a combined 20 and 23-gauge pars plana vitrectomy procedure was performed in 21 eyes for various indications and proposed as a transition procedure to 23-gauge transconjunctival vitrectomy. Through use of combination of procedures postoperative complications, surgical trauma and healing time was decreased; operating time was reduced; costs were decreased.
- Conditions
- Vitrectomy
- Being tested
- 20 and 23 gauge pars plana vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 and 23 gauge pars plana vitrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| vitrectomy | Not described Receives: Procedure: 20 and 23 gauge pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
Secondary outcomes (1)
postoperative complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitrectomyStudies 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
- Observational
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176331
- Sponsor's protocol ID
- KOU-8487358664
- Status last verified
- Jul 2010
- First submitted
- 3 Aug 2010
- Last updated
- 6 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of 20 and 23-gauge Combined Transconjunctival Pars Plana Vitrectomy
- ClinicalTrials.gov ID
- NCT01176331
- Acronym / sponsor ID
- KOU-8487358664
- Conditions
- Vitrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- First posted
- 6 Aug 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.
In a retrospective study, a combined 20 and 23-gauge pars plana vitrectomy procedure was performed in 21 eyes for various indications and proposed as a transition procedure to 23-gauge transconjunctival vitrectomy. Through use of combination of procedures postoperative complications, surgical trauma and healing time was decreased; operating time was reduced; costs were decreased.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vitrectomy | – | Procedure: 20 and 23 gauge pars plana vitrectomy |
Who may qualify
- Ages
- 44 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who were in the range 44 to 80 years, who had to undergo vitrectomy operation with different diagnosis were included in the study. Each participant had a complete ophthalmological examination which included best-corrected visual acuity (BCVA), slit lamp examination with and without pupil dilation, intraocular pressure (IOP) measurement with applanation tonometry and stereoscopic evaluation of the ocular fundus before decision of operation.
Key inclusion criteria (1 listed)
- eyes requiring pars plana vitrectomy for various indications: such as dropped lens, intraocular blood, retinal detachments...etc.
Key exclusion criteria (1 listed)
- patients who did not observed periodically during postoperative period.
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 |
|---|---|---|
| 20 and 23 gauge pars plana vitrectomy | Procedure or surgery | vitrectomy |
Primary outcome
visual acuity
1 secondary outcome
postoperative complications
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 6 Aug 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitrectomy, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 6 Aug 2010. 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 Turkey (Türkiye). 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.
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?
visual acuity. 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 6 Aug 2010.