CataractVICARNCT05583331
Comparison of Two Surgical Sequences "Cataract Surgery Then Vitrectomy" Versus "Vitrectomy Then Cataract Surgery" Under Local-regional Anesthesia
A study testing Cataract surgery and Vitrectomy in people with Cataract and Vitreous Disorder, run by Elsan at 1 site in France.
Trial summary
Cataracts and vitreo-retinal conditions are frequently associated and can lead to a combined surgery to treat both diseases at the same time. To date, in most cases cataract surgery is usually performed first, then followed by vitrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Vitreous Disorder
- What is being tested?
- Cataract surgery and Vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2022to 29 Dec 2023
- 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
- Man or woman aged 18 years old or more
- Patient with macular disease requiring vitrectomy
- Patient with cataract requiring surgery
- Patient suitable for local-regional anesthesia
- Patient suitable for undergoing both surgical procedures consecutively and in any order
- Patient that have given informed consent before performing any study-related procedure
- Patient affiliated to a social security scheme
Who cannot join
- Pseudophakic patients
- Contra-indications to local-regional anesthesia
- Pregnant or breastfeeding patients
- Patients under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Surgical Sequences "Cataract Surgery Then Vitrectomy" Versus "Vitrectomy Then Cataract Surgery" Under Local-regional Anesthesia. a Pilot, Exploratory, Monocentric, Prospective, Randomized Study
Cataracts and vitreo-retinal conditions are frequently associated and can lead to a combined surgery to treat both diseases at the same time. To date, in most cases cataract surgery is usually performed first, then followed by vitrectomy. However, there isn't any standard guidelines indicating what would be the best chronological order, or sequence, when performing those procedures. This randomised, double-arm, open-label study aims at investigating whether the sequence "cataract surgery then vitrectomy" or "vitrectomy then cataract surgery" can have an impact on iris hernia occurence.
Read the detailed description
Cataracts and vitreo-retinal conditions are frequently associated, such as epimacular membranes, vitreomacular tractions, macular holes, or even macular edema. Cataract is also a frequent complication of posterior vitrectomy. Surgical treatment for pre- or post-vitrectomy cataract is corneal phacoemulsification with intraocular lens implantation.
Many patients undergoing vitrectomy alone consult five to ten years later, without useful vision due to a dense cataract that might be more complicated to treat at a late stage. Indeed, if the phacoemulsification on a previously vitrectomized eye is not an issue in the first years, the intervention can be complicated ten years later, due to nuclear hardness and zonular weakness.
To date, there are no recommendations regarding the surgical sequence for the combination of cataract surgery and vitrectomy. The most-used sequence is to start with cataract surgery and then to perform the vitrectomy most often in 25 gauges (retinal surgery). When we start with cataract surgery under locoregional anesthesia, we often have (in about 15% of cases) iris hernia, which causes intraoperative discomfort (need to put stitches on the cornea), intraoperative miosis, pigments release, which can interfere with visualization during vitrectomy and which require dilating agents use.
The hypothesis of this study is that reversing the order of interventions and starting with vitrectomy could in particular reduce the incidence of intraoperative and postoperative complications.
- Conditions
- Cataract, Vitreous Disorder
- Being tested
- Cataract surgery, Vitrectomy
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryProcedure or surgery
Cataract surgery will be performed as per local practice and standard guidelines.
VitrectomyProcedure or surgery
Vitrectomy will be performed as per local practice and standard guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Cataract surgery then Vitrectomy | Active comparator | Patients will undergo first the cataract surgery then the vitrectomy, as a combined surgery performed on the same day. Receives: Procedure: Cataract surgery; Procedure: Vitrectomy |
| Vitrectomy then cataract surgery | Experimental | Patients will undergo first the vitrectomy then the cataract surgery, as a combined surgery performed on the same day. Receives: Procedure: Cataract surgery; Procedure: Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative iris hernia occurence
Measured: During the combined surgery
Secondary outcomes (6)
Other intraoperative complications occurence
Measured: During the combined surgery
Post-operative complications occurence
Measured: At 6 months after the combined surgery
Combined surgery duration in minutes
Measured: At the end of the combined surgery
Ocular hypertension occurence
Measured: At 1 month, 3 months and 6 months after combined surgery
Combined Surgery-related costs assessment
Measured: At the time of the combined surgery.
Visual acuity assessment
Measured: At 6 months after combined surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start15 Dec 2022
- Primary completion29 Sep 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomised, double-arms, parallel, open-label study.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583331
- Sponsor's protocol ID
- VICAR
- Other IDs
- 2022-A00886-37
- Acronym
- VICAR
- Status last verified
- Sep 2024
- First submitted
- 13 Oct 2022
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Surgical Sequences "Cataract Surgery Then Vitrectomy" Versus "Vitrectomy Then Cataract Surgery" Under Local-regional Anesthesia. a Pilot, Exploratory, Monocentric, Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT05583331
- Acronym / sponsor ID
- VICAR / VICAR
- Conditions
- Cataract, Vitreous Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 17 Oct 2022 (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.
Cataracts and vitreo-retinal conditions are frequently associated and can lead to a combined surgery to treat both diseases at the same time. To date, in most cases cataract surgery is usually performed first, then followed by vitrectomy. However, there isn't any standard guidelines indicating what would be the best chronological order, or sequence, when performing those procedures. This randomised, double-arm, open-label study aims at investigating whether the sequence "cataract surgery then vitrectomy" or "vitrectomy then cataract surgery" can have an impact on iris hernia occurence.
Detailed description
Cataracts and vitreo-retinal conditions are frequently associated, such as epimacular membranes, vitreomacular tractions, macular holes, or even macular edema. Cataract is also a frequent complication of posterior vitrectomy. Surgical treatment for pre- or post-vitrectomy cataract is corneal phacoemulsification with intraocular lens implantation.
Many patients undergoing vitrectomy alone consult five to ten years later, without useful vision due to a dense cataract that might be more complicated to treat at a late stage. Indeed, if the phacoemulsification on a previously vitrectomized eye is not an issue in the first years, the intervention can be complicated ten years later, due to nuclear hardness and zonular weakness.
To date, there are no recommendations regarding the surgical sequence for the combination of cataract surgery and vitrectomy. The most-used sequence is to start with cataract surgery and then to perform the vitrectomy most often in 25 gauges (retinal surgery). When we start with cataract surgery under locoregional anesthesia, we often have (in about 15% of cases) iris hernia, which causes intraoperative discomfort (need to put stitches on the cornea), intraoperative miosis, pigments release, which can interfere with visualization during vitrectomy and which require dilating agents use.
The hypothesis of this study is that reversing the order of interventions and starting with vitrectomy could in particular reduce the incidence of intraoperative and postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, randomised, double-arms, parallel, open-label study.
| Arm | Type | Receives |
|---|---|---|
| Cataract surgery then Vitrectomy | Active comparator | Procedure: Cataract surgery, Procedure: VitrectomyPatients will undergo first the cataract surgery then the vitrectomy, as a combined surgery performed on the same day. |
| Vitrectomy then cataract surgery | Experimental | Procedure: Cataract surgery, Procedure: VitrectomyPatients will undergo first the vitrectomy then the cataract surgery, as a combined surgery performed on the same day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Man or woman aged 18 years old or more
- Patient with macular disease requiring vitrectomy
- Patient with cataract requiring surgery
- Patient suitable for local-regional anesthesia
- Patient suitable for undergoing both surgical procedures consecutively and in any order
Key exclusion criteria (4 listed)
- Pseudophakic patients
- Contra-indications to local-regional anesthesia
- Pregnant or breastfeeding patients
- Patients under legal protection
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 |
|---|---|---|
| Cataract surgeryCataract surgery will be performed as per local practice and standard guidelines. | Procedure or surgery | Cataract surgery then Vitrectomy, Vitrectomy then cataract surgery |
| VitrectomyVitrectomy will be performed as per local practice and standard guidelines. | Procedure or surgery | Cataract surgery then Vitrectomy, Vitrectomy then cataract surgery |
Primary outcome
Intraoperative iris hernia occurence
Time frame: During the combined surgery
6 secondary outcomes
Other intraoperative complications occurence
Time frame: During the combined surgery
Post-operative complications occurence
Time frame: At 6 months after the combined surgery
Combined surgery duration in minutes
Time frame: At the end of the combined surgery
Ocular hypertension occurence
Time frame: At 1 month, 3 months and 6 months after combined surgery
Combined Surgery-related costs assessment
Time frame: At the time of the combined surgery.
Visual acuity assessment
Time frame: At 6 months after combined surgery.
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 5 Sep 2024.
- 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.
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 Cataract surgery and Vitrectomy in people with Cataract and Vitreous Disorder, run by Elsan at 1 site in France.
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: finished, as of the sponsor's last update on 5 Sep 2024. 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 France. 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?
Intraoperative iris hernia occurence (time frame: During the combined surgery). 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 5 Sep 2024.