Cystoid Macular EdemaNCT05069675
Cystoid Macular Edema After Vitrectomy for Rhegmatogenous Retinal Detachment
An observational study of Cystoid Macular Edema, run by University of Catania at 6 sites in Italy.
Trial summary
To investigate the incidence of cystoid macular edema in eyes with primary rhegmatogenous retinal detachment successfully treated with vitrectomy with gas tamponade, and to evaluate the clinical variables associated with its development. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystoid Macular Edema
- What is being tested?
- vitrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 6 sitesItaly
- Study dates
- 12 Jul 2021to Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patients with primary regmatogenous retinal detechment successfully treated by vitrectomy with gas tamnponade at several Eye Centers, will be included in the study. clinical data will be retrospectively retrieved.
Who may be able to join
- primary rhegmatogenous retinal detachment treated with vitrectomy with gas tamponade;
- follow-up of 3 months or more;
- age > 18 years ;
- no previous eye surgery, except cataract surgery performed at least 6 months after hospitalization for retinal detachment;
- anatomical success, i.e. retinal re-attachment, after a single gas vitrectomy;
- no other eye surgery during follow-up;
- availability of optical coherence tomography (OCT) imaging
Who cannot join
- history of other eye diseases (glaucoma, age-related macular degeneration, uveitis, diabetic retinopathy, maculopathy);
- macular hole;
- recurrent retinal detachment;
- use of silicone oil is used as a tamponading agent
Trial locations and contacts
6 sites in 1 country.
Matteo R Fallico, MD, PhD contact
6 sites in 1 country
Italy6 sites, 6 recruiting
- Recruiting
Eye Clinic, University of Bari
Bari
Francesco Boscia, MD
- Recruiting
Eye Clinic, Humanitas University
Bergamo
Mario Romano, MD, PhD
- Recruiting
Eye Clinic, Azienda Policlinico San Marco
Catania, 95123
Antonio Longo, MD PhD, antlongo@unict.it
- Recruiting
Eye Clinic, University of Palermo
Palermo
Vincenza Bonfiglio, MD, PhD, enzabonfiglio@gmail.com
- Recruiting
Eye Clinic, University of Perugia
Perugia
Marco Lupidi, MD
- Recruiting
Eye Clinic University of Turin
Turin
Michele Reibaldi, MD PhD, mreibaldi@libero.it
About this study
Official title: Incidence and Risk Factors for Cystoid Macular Edema After Primary Vitrectomy With Gas Tamponade for Rhegmatogenous Retinal Detachment: a National Study Group
To investigate the incidence of cystoid macular edema in eyes with primary rhegmatogenous retinal detachment successfully treated with vitrectomy with gas tamponade, and to evaluate the clinical variables associated with its development.
Read the detailed description
this is an observational, retrospective, multicentre study. The study is based on the retrospective collection of clinical data from patients undergoing gas tamponade vitrectomy for rhegmatogenous retinal detachment. The collection of such data by the investigators will take place at each participating center anonymously.
demographics, systemic, and preoperative, intraoperative and post-operative data will be collected The sample size was calculated to obtain approximately 200 patients with cystoid macular edema. Since cystoid macular edema has been detected in 13% of patients after retinal detachment gas vitrectomy, and assuming that this event can occur between 10% and 15% of cases, the study will include at least 2000 cases.
- Conditions
- Cystoid Macular Edema
- Being tested
- vitrectomy
- Keywords
- cystoid macular edema, rhegmatogenous retinal detachment, vitrectomy, gas tamponade
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitrectomyProcedure or surgery
vitrectomy with gas tamponade
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of cystoid macular edema
cystoid macular edema assessed by OCT (central subfield thickness >310 micron, with presence of intraretinal cystic areas of low reflectivity in OPL) visual acuity
Measured: from 1 month up to 6 months after surgery
Secondary outcomes (1)
factors related to development of macular edema
demographics, systemic and ocular parameters
Measured: from 1 month up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start12 Jul 2021
- Primary completionOct 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cystoid Macular EdemaStudies 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Longo, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069675
- Sponsor's protocol ID
- 69/2021/PO
- Status last verified
- May 2022
- First submitted
- 20 Sep 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chatziralli I, Theodossiadis G, Dimitriou E, Kazantzis D, Theodossiadis P. Macular Edema after Successful Pars Plana Vitrectomy for Rhegmatogenous Retinal Detachment: Factors Affecting Edema Development and Considerations for Treatment. Ocul Immunol Inflamm. 2021 Jan 2;29(1):187-192. doi: 10.1080/09273948.2019.1652330. Epub 2019 Oct 2.
PubMed 31577459Banker TP, Reilly GS, Jalaj S, Weichel ED. Epiretinal membrane and cystoid macular edema after retinal detachment repair with small-gauge pars plana vitrectomy. Eur J Ophthalmol. 2015 Nov-Dec;25(6):565-70. doi: 10.5301/ejo.5000609. Epub 2015 Apr 15.
PubMed 25907288Joseph DP, Ryan EH, Ryan CM, Forbes NJK, Wagley S, Yonekawa Y, Mittra RA, Parke DW, Emerson GG, Shah GK, Blinder KJ, Capone A, Williams GA, Eliott D, Gupta OP, Hsu J, Regillo CD. Primary Retinal Detachment Outcomes Study: Pseudophakic Retinal Detachment Outcomes: Primary Retinal Detachment Outcomes Study Report Number 3. Ophthalmology. 2020 Nov;127(11):1507-1514. doi: 10.1016/j.ophtha.2020.05.005. Epub 2020 May 8.
PubMed 32437865
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors for Cystoid Macular Edema After Primary Vitrectomy With Gas Tamponade for Rhegmatogenous Retinal Detachment: a National Study Group
- ClinicalTrials.gov ID
- NCT05069675
- Acronym / sponsor ID
- 69/2021/PO
- Conditions
- Cystoid Macular Edema
- Keywords
- cystoid macular edema, rhegmatogenous retinal detachment, vitrectomy, gas tamponade
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 6 Oct 2021 (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 investigate the incidence of cystoid macular edema in eyes with primary rhegmatogenous retinal detachment successfully treated with vitrectomy with gas tamponade, and to evaluate the clinical variables associated with its development.
Detailed description
this is an observational, retrospective, multicentre study. The study is based on the retrospective collection of clinical data from patients undergoing gas tamponade vitrectomy for rhegmatogenous retinal detachment. The collection of such data by the investigators will take place at each participating center anonymously.
demographics, systemic, and preoperative, intraoperative and post-operative data will be collected The sample size was calculated to obtain approximately 200 patients with cystoid macular edema. Since cystoid macular edema has been detected in 13% of patients after retinal detachment gas vitrectomy, and assuming that this event can occur between 10% and 15% of cases, the study will include at least 2000 cases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients with primary regmatogenous retinal detechment successfully treated by vitrectomy with gas tamnponade at several Eye Centers, will be included in the study. clinical data will be retrospectively retrieved.
Key inclusion criteria (7 listed)
- primary rhegmatogenous retinal detachment treated with vitrectomy with gas tamponade;
- follow-up of 3 months or more;
- age > 18 years ;
- no previous eye surgery, except cataract surgery performed at least 6 months after hospitalization for retinal detachment;
- anatomical success, i.e. retinal re-attachment, after a single gas vitrectomy;
Key exclusion criteria (4 listed)
- history of other eye diseases (glaucoma, age-related macular degeneration, uveitis, diabetic retinopathy, maculopathy);
- macular hole;
- recurrent retinal detachment;
- use of silicone oil is used as a tamponading agent
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 |
|---|---|---|
| vitrectomyvitrectomy with gas tamponade | Procedure or surgery | – |
Primary outcome
incidence of cystoid macular edema
Time frame: from 1 month up to 6 months after surgery
cystoid macular edema assessed by OCT (central subfield thickness >310 micron, with presence of intraretinal cystic areas of low reflectivity in OPL) visual acuity
1 secondary outcome
factors related to development of macular edema
Time frame: from 1 month up to 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Background: PubMed 31577459Chatziralli I, Theodossiadis G, Dimitriou E, Kazantzis D, Theodossiadis P. Macular Edema after Successful Pars Plana Vitrectomy for Rhegmatogenous Retinal Detachment: Factors Affecting Edema Development and Considerations for Treatment. Ocul Immunol Inflamm. 2021 Jan 2;29(1):187-192. doi: 10.1080/09273948.2019.1652330. Epub 2019 Oct 2.
- Background: PubMed 25907288Banker TP, Reilly GS, Jalaj S, Weichel ED. Epiretinal membrane and cystoid macular edema after retinal detachment repair with small-gauge pars plana vitrectomy. Eur J Ophthalmol. 2015 Nov-Dec;25(6):565-70. doi: 10.5301/ejo.5000609. Epub 2015 Apr 15.
- Background: PubMed 32437865Joseph DP, Ryan EH, Ryan CM, Forbes NJK, Wagley S, Yonekawa Y, Mittra RA, Parke DW, Emerson GG, Shah GK, Blinder KJ, Capone A, Williams GA, Eliott D, Gupta OP, Hsu J, Regillo CD. Primary Retinal Detachment Outcomes Study: Pseudophakic Retinal Detachment Outcomes: Primary Retinal Detachment Outcomes Study Report Number 3. Ophthalmology. 2020 Nov;127(11):1507-1514. doi: 10.1016/j.ophtha.2020.05.005. Epub 2020 May 8.
- Individual participant dataSharing planned: No
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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.
Matteo R Fallico, MD, PhD contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystoid Macular Edema, run by University of Catania at 6 sites in Italy.
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 7 inclusion and 4 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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. 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?
Contact Antonio Longo, MD, PhD (+393460131548, antlongo@unict.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of cystoid macular edema (time frame: from 1 month up to 6 months after surgery). 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 NCT05069675, which also lists 3 linked publications.
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 25 May 2022.