Small PupilADICC-IDNCT02434588
Evaluation of an Iris Dilatation Ring in Cataract Surgery (ADICC-ID)
A study testing Bhattacharjee ring in people with Small Pupil, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
During cataract surgery, it is necessary to dilate the iris in order to remove the crystalline lens and position the implant. The diameter of the optical implant being 6 mm, in case of capsulorhexis crystalline access 5.5 mm, the expansion should be at least 6 mm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Pupil
- What is being tested?
- Bhattacharjee ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2015to Jul 2018
- 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
- Patient with programmed cataract surgery under topical or local anesthesia
- Need to use a dilatation ring during operation, highlighted by iris dilatation ≤ 6 mm on slitlamp, after mydriatic solution and 10% phenylephrine eye drops instillation
Who cannot join
- Pregnant or breastfeeding woman
- Patient's refusal to participate in the study
- Patient non covered by health insurance
- Complete iridectomy
- Tearing of iris sphincter
- Important posterior synechiae (when the iris is attached to the anterior surface of the implant)
- Anterior chamber very deep (depth of the anterior chamber lower than 1mm after injection of the viscous product)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Iris Dilatation Ring in Cataract Surgery
During cataract surgery, it is necessary to dilate the iris in order to remove the crystalline lens and position the implant. The diameter of the optical implant being 6 mm, in case of capsulorhexis crystalline access 5.5 mm, the expansion should be at least 6 mm.
At pre-operative consultation, the iris is always dilated by instillation of eye drops and measured at the slitlamp. For patients with an inadequate dilation, the intervention requires the use of a mechanical dilatation device.
Read more
This study aims to assess the value of an alternative dilatation ring to Malyugin ring, which can be inserted and removed through an incision of less than 2 mm in diameter, due to its size smaller than that of the Malyugin ring.
Our hypothesis is that this Bhattacharjee ring ensures sufficient and stable iris dilation during surgery, enabling implant placement in good conditions.
- Conditions
- Small Pupil
- Being tested
- Bhattacharjee ring
- Medical subject headings
- Miosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bhattacharjee ringDevice
Insertion of a Bhattacharjee ring to stabilise the pupil during cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Bhattacharjee ring | Experimental | Not described Receives: Device: Bhattacharjee ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with dilated iris ≥ 6 mm
Measured: Immediately after ring insertion
Secondary outcomes (5)
Proportion of patients with dilated iris ≥ 6 mm after instillation of dilating eye drops
Measured: Immediately before ring insertion
Proportion of patients with ≥ 6mm iris dilation after surgery
Measured: Just before ring removal
Proportion of patients with iris retraction ≤ 4 mm immediately
Measured: Immediatly after ring removal
Surgeon feeling operational conditions on an visual analogic scale
Measured: Immediatly after ring insertion
Change for Malyugin ring during surgery
Measured: Just before ring insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study start14 Apr 2015
- Primary completionJun 2018
- Study completionJul 2018
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 Small PupilStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434588
- Sponsor's protocol ID
- JFO_2014-27
- Other IDs
- ID-RCB 2014-A01880-47
- Acronym
- ADICC-ID
- Status last verified
- Aug 2018
- First submitted
- 14 Apr 2015
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Salviat F, Febbraro JL, Zuber K, Yavchitz A, Moran S, Gatinel D. Evaluation of a uniplanar pupil expansion ring in small-pupil cataract surgery: a feasibility study. Int Ophthalmol. 2022 Feb;42(2):489-496. doi: 10.1007/s10792-021-02065-9. Epub 2021 Oct 16.
PubMed 34655377
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Iris Dilatation Ring in Cataract Surgery
- ClinicalTrials.gov ID
- NCT02434588
- Acronym / sponsor ID
- ADICC-ID / JFO_2014-27
- Conditions
- Small Pupil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 14 Apr 2015 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 5 May 2015 (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.
During cataract surgery, it is necessary to dilate the iris in order to remove the crystalline lens and position the implant. The diameter of the optical implant being 6 mm, in case of capsulorhexis crystalline access 5.5 mm, the expansion should be at least 6 mm.
At pre-operative consultation, the iris is always dilated by instillation of eye drops and measured at the slitlamp. For patients with an inadequate dilation, the intervention requires the use of a mechanical dilatation device.
This study aims to assess the value of an alternative dilatation ring to Malyugin ring, which can be inserted and removed through an incision of less than 2 mm in diameter, due to its size smaller than that of the Malyugin ring.
Our hypothesis is that this Bhattacharjee ring ensures sufficient and stable iris dilation during surgery, enabling implant placement in good conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bhattacharjee ring | Experimental | Device: Bhattacharjee ring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with programmed cataract surgery under topical or local anesthesia
- Need to use a dilatation ring during operation, highlighted by iris dilatation ≤ 6 mm on slitlamp, after mydriatic solution and 10% phenylephrine eye drops instillation
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding woman
- Patient's refusal to participate in the study
- Patient non covered by health insurance
- Complete iridectomy
- Tearing of iris sphincter
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 |
|---|---|---|
| Bhattacharjee ringInsertion of a Bhattacharjee ring to stabilise the pupil during cataract surgery | Device | Bhattacharjee ring |
Primary outcome
Proportion of patients with dilated iris ≥ 6 mm
Time frame: Immediately after ring insertion
5 secondary outcomes
Proportion of patients with dilated iris ≥ 6 mm after instillation of dilating eye drops
Time frame: Immediately before ring insertion
Proportion of patients with ≥ 6mm iris dilation after surgery
Time frame: Just before ring removal
Proportion of patients with iris retraction ≤ 4 mm immediately
Time frame: Immediatly after ring removal
Surgeon feeling operational conditions on an visual analogic scale
Time frame: Immediatly after ring insertion
Change for Malyugin ring during surgery
Time frame: Just before ring insertion
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 31 Aug 2018.
- Derived from this study: PubMed 34655377Salviat F, Febbraro JL, Zuber K, Yavchitz A, Moran S, Gatinel D. Evaluation of a uniplanar pupil expansion ring in small-pupil cataract surgery: a feasibility study. Int Ophthalmol. 2022 Feb;42(2):489-496. doi: 10.1007/s10792-021-02065-9. Epub 2021 Oct 16.
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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 Bhattacharjee ring in people with Small Pupil, run by Fondation Ophtalmologique Adolphe de Rothschild 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 2 inclusion and 7 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 31 Aug 2018. 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?
Proportion of patients with dilated iris ≥ 6 mm (time frame: Immediately after ring insertion). 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 NCT02434588, 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 31 Aug 2018.