Macular Hole20Gvs23GNCT01969929
Comparison of Postoperative Aqueous Flare After 20G Versus 23G Pars Plana Vitrectomy
A study testing 20G Vitrectomy and 23G vitrectomy in people with Macular Hole and Macular Pucker, run by University of Cologne at 1 site in Germany.
Trial summary
To compare postoperative inflammation and breakdown of blood-retinal barrier as measured by a laser flare-cell meter in 20G versus 23G vitrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Hole, Macular Pucker
- What is being tested?
- 20G Vitrectomy and 23G vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Oct 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years macular hole macular pucker willing to perform follow up written signed consent
Who cannot join
- other relevant eye disease: retinal detachment, provect cataract, diabetic retinopathy, AMD, relevant glaucoma, pre-surgery except for cataract surgery
Trial locations and contacts
1 site in 1 country.
Germany1 site
Center of Ophthalmology, University of Cologne
Cologne, North Rhine-Westphalia, 50937
About this study
To compare postoperative inflammation and breakdown of blood-retinal barrier as measured by a laser flare-cell meter in 20G versus 23G vitrectomy.
- Conditions
- Macular Hole, Macular Pucker
- Being tested
- 20G Vitrectomy, 23G vitrectomy
- Medical subject headings
- Retinal Perforations, Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20G VitrectomyProcedure or surgery
23G vitrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 20G | Active comparator | 20G vitrectomy with scleral and conjunctival sutures for closure Receives: Procedure: 20G Vitrectomy |
| 23G | Active comparator | 23G transconjunctival sutureless vitrectomy Receives: Procedure: 23G vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alteration of aqueous flare between preoperative and 3-week-postoperative time point
Measured: 3 weeks
Secondary outcomes (2)
Visual acuity change
Measured: 3 weeks
Closure of Macular hole
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
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 Macular HoleStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sascha Fauser, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969929
- Sponsor's protocol ID
- UKK-13-247
- Other IDs
- 13-247
- Acronym
- 20Gvs23G
- Status last verified
- May 2015
- First submitted
- 18 Oct 2013
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Scholz P, Muther PS, Schiller P, Felsch M, Fauser S. A Randomized Controlled Clinical Trial Comparing 20 Gauge and 23 Gauge Vitrectomy for Patients with Macular Hole or Macular Pucker. Adv Ther. 2018 Dec;35(12):2152-2166. doi: 10.1007/s12325-018-0826-6. Epub 2018 Nov 17.
PubMed 30448886
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Aqueous Flare After 20G Versus 23G Pars Plana Vitrectomy
- ClinicalTrials.gov ID
- NCT01969929
- Acronym / sponsor ID
- 20Gvs23G / UKK-13-247
- Conditions
- Macular Hole, Macular Pucker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 25 Oct 2013 (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 postoperative inflammation and breakdown of blood-retinal barrier as measured by a laser flare-cell meter in 20G versus 23G vitrectomy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20G | Active comparator | Procedure: 20G Vitrectomy20G vitrectomy with scleral and conjunctival sutures for closure |
| 23G | Active comparator | Procedure: 23G vitrectomy23G transconjunctival sutureless vitrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age > 18 years macular hole macular pucker willing to perform follow up written signed consent
Key exclusion criteria (1 listed)
- other relevant eye disease: retinal detachment, provect cataract, diabetic retinopathy, AMD, relevant glaucoma, pre-surgery except for cataract 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 |
|---|---|---|
| 20G Vitrectomy | Procedure or surgery | 20G |
| 23G vitrectomy | Procedure or surgery | 23G |
Primary outcome
Alteration of aqueous flare between preoperative and 3-week-postoperative time point
Time frame: 3 weeks
2 secondary outcomes
Visual acuity change
Time frame: 3 weeks
Closure of Macular hole
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Derived from this study: PubMed 30448886Scholz P, Muther PS, Schiller P, Felsch M, Fauser S. A Randomized Controlled Clinical Trial Comparing 20 Gauge and 23 Gauge Vitrectomy for Patients with Macular Hole or Macular Pucker. Adv Ther. 2018 Dec;35(12):2152-2166. doi: 10.1007/s12325-018-0826-6. Epub 2018 Nov 17.
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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?
A study testing 20G Vitrectomy and 23G vitrectomy in people with Macular Hole and Macular Pucker, run by University of Cologne at 1 site in Germany.
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: status not confirmed, as of the sponsor's last update on 1 Jun 2015. 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 Germany. 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?
Results are not available in the source record.
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?
Alteration of aqueous flare between preoperative and 3-week-postoperative time point (time frame: 3 weeks). 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 NCT01969929, 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 1 Jun 2015.