Macular HolesPhase 4NCT04527848
Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery
A Phase 4 study testing small amount of undiluted C3F8 in people with Macular Holes, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
To undertake a prospective randomized clinical trial of vitrectomy and gas tamponade to treat macular hole, utilizing a small amount of undiluted C3F8 (perfluoropropane) versus a large amount of diluted C3F8 versus a small amount of undiluted SF6 (sulfur hexafluoride) versus a large amount of diluted SF6. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Holes
- What is being tested?
- small amount of undiluted C3F8
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- 10 May 2016to 31 Jul 2020
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pseudophakia
- without previous vitreoretinal surgery
- diagnosed with a full-thickness macula hole on the optical coherence tomography exam.
- duration of symptoms less than 6 months
- inform consent
Who cannot join
- ocular trauma
- allergy to any of the products used in the study,
- need to travel by plane in the first 60 postoperative days
- myopia over 6 diopters or axial diameter over 26 mm
- retinal dystrophies
- retinal detachment
Show all 9Show fewer
- abnormal eye shape
- glaucoma
- diabetic retinopathy or other eye comorbidities.
Trial locations and contacts
1 site in 1 country.
About this study
To undertake a prospective randomized clinical trial of vitrectomy and gas tamponade to treat macular hole, utilizing a small amount of undiluted C3F8 (perfluoropropane) versus a large amount of diluted C3F8 versus a small amount of undiluted SF6 (sulfur hexafluoride) versus a large amount of diluted SF6.
- Conditions
- Macular Holes
- Being tested
- small amount of undiluted C3F8
- Keywords
- macular holes, Injections, Intra-Ocular, gases
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
small amount of undiluted C3F8Drug
vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection
| Study group | Role | What they receive |
|---|---|---|
| small amount of undiluted C3F8 | Experimental | Not described Receives: Drug: small amount of undiluted C3F8 |
| large amount of diluted C3f8 | Active comparator | Not described Receives: Drug: small amount of undiluted C3F8 |
| small amount of undiluted SF6 | Active comparator | Not described Receives: Drug: small amount of undiluted C3F8 |
| large amount of diluted SF6 | Active comparator | Not described Receives: Drug: small amount of undiluted C3F8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gas duration
duration of intraocular gas
Measured: up to 60 days
macula hole closure
closure of the macular hole after the primary surgical procedure
Measured: 26 weeks
Secondary outcomes (2)
visual acuity
corrected distance visual acuity
Measured: preoperative, 26 weeks
intraocular pressure
intraocular pressure
Measured: preoperative, 1 day, 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start10 May 2016
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HolesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Pessoa Cavalcanti Lira, Universidade Federal de Pernambuco
- Investigators
- Rodrigo PC Lira, PhD, Principal investigator, UFPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527848
- Sponsor's protocol ID
- 12347319.9.0000.8807
- Status last verified
- Dec 2020
- First submitted
- 23 Aug 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery
- ClinicalTrials.gov ID
- NCT04527848
- Acronym / sponsor ID
- 12347319.9.0000.8807
- Conditions
- Macular Holes
- Keywords
- macular holes, Injections, Intra-Ocular, gases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 10 May 2016 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 27 Aug 2020 (actual)
- 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 undertake a prospective randomized clinical trial of vitrectomy and gas tamponade to treat macular hole, utilizing a small amount of undiluted C3F8 (perfluoropropane) versus a large amount of diluted C3F8 versus a small amount of undiluted SF6 (sulfur hexafluoride) versus a large amount of diluted SF6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| small amount of undiluted C3F8 | Experimental | Drug: small amount of undiluted C3F8 |
| large amount of diluted C3f8 | Active comparator | Drug: small amount of undiluted C3F8 |
| small amount of undiluted SF6 | Active comparator | Drug: small amount of undiluted C3F8 |
| large amount of diluted SF6 | Active comparator | Drug: small amount of undiluted C3F8 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pseudophakia
- without previous vitreoretinal surgery
- diagnosed with a full-thickness macula hole on the optical coherence tomography exam.
- duration of symptoms less than 6 months
- inform consent
Key exclusion criteria (9 listed)
- ocular trauma
- allergy to any of the products used in the study,
- need to travel by plane in the first 60 postoperative days
- myopia over 6 diopters or axial diameter over 26 mm
- retinal dystrophies
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 |
|---|---|---|
| small amount of undiluted C3F8vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection | Drug | large amount of diluted C3f8, large amount of diluted SF6, small amount of undiluted C3F8, small amount of undiluted SF6 |
Primary outcome
Gas duration
Time frame: up to 60 days
duration of intraocular gas
macula hole closure
Time frame: 26 weeks
closure of the macular hole after the primary surgical procedure
2 secondary outcomes
visual acuity
Time frame: preoperative, 26 weeks
intraocular pressure
Time frame: preoperative, 1 day, 26 weeks
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 9 Dec 2020.
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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.
Rodrigo PC Lira, PhD principal investigator
UFPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing small amount of undiluted C3F8 in people with Macular Holes, run by Universidade Federal de Pernambuco 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 5 inclusion and 9 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 9 Dec 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Gas duration (time frame: up to 60 days). 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 9 Dec 2020.