Dissociated Vertical DeviationNCT05980962
Inferior Oblique Muscle Anteriorization Versus Anteriorization and Resection in DVD With IOOA
A study testing Inferior oblique anteriorization and Inferior oblique anteriorization together with unliateral resction in people with Dissociated Vertical Deviation and Inferior Oblique Overaction, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the results of two surgical modalities in patients with Dissociated vertical deviation with inferior oblique muscle overaction . The main questions it aims to answer are: How much does the magnitude of DVD improve after each modality? Is the IOOA eliminated? Participants… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Dissociated Vertical Deviation, Inferior Oblique Overaction
- What is being tested?
- Inferior oblique anteriorization and Inferior oblique anteriorization together with unliateral resction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 15 Jul 2022
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Manifest DVD decompensated to a tropia with free ocular motility
- Cases with or without horizontal misalignment
- Cases with or without previous horizontal muscle surgery
Who cannot join
- Incomitant, Paralytic or restrictive strabismus
- Eyes with previous inferior oblique muscle surgery
- Recurrent DVD after surgical treatment
- Eyes with previous scleral buckling for retinal deatchment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anteriorization of the Inferior Oblique Muscle Versus Anteriorization and Resection for Asymmetrical Dissociated Vertical Deviation With Inferior Oblique Muscle Overaction
The goal of this clinical trial is to compare the results of two surgical modalities in patients with Dissociated vertical deviation with inferior oblique muscle overaction . The main questions it aims to answer are:
- How much does the magnitude of DVD improve after each modality?
- Is the IOOA eliminated? Participants will be divided into two equal groups; Researchers will compare the efficacy of symmetrical anteriorization of the inferior oblique and adding an additional rescetion to one eye in the second group to see which group had more signifcant reduction in the magnitude of DVD and IOOA.
Read the detailed description
A prospective study was performed on patients with bilateral symmterical dissociated vertical deviation(DVD) and bilateral inferior oblique muscle overaction (IOOA) in Cairo University hospitals starting from February 2018 through December 2021. Patients wetre included in the study if they had a minimum follow up period of 6 months. The study included 54 patients (108 eyes) with manifest DVD and IOOA in boths eyes. Patients were divided into two equal groups. The paitents in group 1 underwent symmetrical inferior oblique muscle anteriorization, while the patients in group 2 underwent ayymmetrical surgery , where inferior oblique anteriorization was performed in one eye the same manner is in group 1, and the eye with the larger deviation had an additional 3-5 mm rescetion of the inferior oblique muscle along with anteriorization according to the measured DVD difference between both eyes, whether less than or more than 5 prism diopters respectively.
- Being tested
- Inferior oblique anteriorization, Inferior oblique anteriorization together with unliateral resction
- Keywords
- DVD, IOOA, IO Anteriorization, IO Anteriorization with rescetion
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior oblique anteriorizationProcedure or surgery
symmterical anteriorization the the inferior oblique muscle 1 mm behind and lateral to the inferior rectus insertion
Inferior oblique anteriorization together with unliateral resctionProcedure or surgery
asymmterical surgery, anteriorization the the inferior oblique muscle 1 mm behind and lateral to the inferior rectus insertion in one eye, and an additional 3-5 mm resction of the inferior oblique in the eye with the larger devation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Anteriorization group) | Active comparator | Symmetrical Anteriorization of the inferior oblique muscle Receives: Procedure: Inferior oblique anteriorization |
| Group 2 (Resction group) | Experimental | Asymmetrical Anteriorization of the inferior oblique muscle, where an additional resection of the inferior oblique was done for the eye with the larger deviation Receives: Procedure: Inferior oblique anteriorization together with unliateral resction |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of the magnitude of DVD
degree of reduction of the deviation measured in prism diopters
Measured: 1 week ,1 month, three months, six months
Secondary outcomes (1)
reduction of magnitude of IOOA
redctuon in the measured degree of IOOA
Measured: 1 week ,1 month, three months, six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Dec 2018
- Primary completion31 Dec 2021
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dissociated Vertical DeviationStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Osama Mohamed, Kasr El Aini Hospital
- Investigators
- Hala M. Elhiliali, Study chair, Cairo UniversityMagda S. Abdel-Aziz, Study director, Cairo UniversityHeba M. Fouad, Study director, Cairo UniversityGhada O. Mohamed, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980962
- Sponsor's protocol ID
- N-97-2018
- Status last verified
- Jul 2023
- First submitted
- 31 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anteriorization of the Inferior Oblique Muscle Versus Anteriorization and Resection for Asymmetrical Dissociated Vertical Deviation With Inferior Oblique Muscle Overaction
- ClinicalTrials.gov ID
- NCT05980962
- Acronym / sponsor ID
- N-97-2018
- Keywords
- DVD, IOOA, IO Anteriorization, IO Anteriorization with rescetion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 8 Aug 2023 (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.
The goal of this clinical trial is to compare the results of two surgical modalities in patients with Dissociated vertical deviation with inferior oblique muscle overaction . The main questions it aims to answer are:
- How much does the magnitude of DVD improve after each modality?
- Is the IOOA eliminated? Participants will be divided into two equal groups; Researchers will compare the efficacy of symmetrical anteriorization of the inferior oblique and adding an additional rescetion to one eye in the second group to see which group had more signifcant reduction in the magnitude of DVD and IOOA.
Detailed description
A prospective study was performed on patients with bilateral symmterical dissociated vertical deviation(DVD) and bilateral inferior oblique muscle overaction (IOOA) in Cairo University hospitals starting from February 2018 through December 2021. Patients wetre included in the study if they had a minimum follow up period of 6 months. The study included 54 patients (108 eyes) with manifest DVD and IOOA in boths eyes. Patients were divided into two equal groups. The paitents in group 1 underwent symmetrical inferior oblique muscle anteriorization, while the patients in group 2 underwent ayymmetrical surgery , where inferior oblique anteriorization was performed in one eye the same manner is in group 1, and the eye with the larger deviation had an additional 3-5 mm rescetion of the inferior oblique muscle along with anteriorization according to the measured DVD difference between both eyes, whether less than or more than 5 prism diopters respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Anteriorization group) | Active comparator | Procedure: Inferior oblique anteriorizationSymmetrical Anteriorization of the inferior oblique muscle |
| Group 2 (Resction group) | Experimental | Procedure: Inferior oblique anteriorization together with unliateral resctionAsymmetrical Anteriorization of the inferior oblique muscle, where an additional resection of the inferior oblique was done for the eye with the larger deviation |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Manifest DVD decompensated to a tropia with free ocular motility
- Cases with or without horizontal misalignment
- Cases with or without previous horizontal muscle surgery
Key exclusion criteria (4 listed)
- Incomitant, Paralytic or restrictive strabismus
- Eyes with previous inferior oblique muscle surgery
- Recurrent DVD after surgical treatment
- Eyes with previous scleral buckling for retinal deatchment
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 |
|---|---|---|
| Inferior oblique anteriorizationsymmterical anteriorization the the inferior oblique muscle 1 mm behind and lateral to the inferior rectus insertion | Procedure or surgery | Group 1 (Anteriorization group) |
| Inferior oblique anteriorization together with unliateral resctionasymmterical surgery, anteriorization the the inferior oblique muscle 1 mm behind and lateral to the inferior rectus insertion in one eye, and an additional 3-5 mm resction of the inferior oblique in the eye with the larger devation | Procedure or surgery | Group 2 (Resction group) |
Primary outcome
reduction of the magnitude of DVD
Time frame: 1 week ,1 month, three months, six months
degree of reduction of the deviation measured in prism diopters
1 secondary outcome
reduction of magnitude of IOOA
Time frame: 1 week ,1 month, three months, six months
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 8 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Dissociated Vertical Deviation
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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.
Hala M. Elhiliali study chair
Cairo University
Magda S. Abdel-Aziz study director
Cairo University
Heba M. Fouad study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inferior oblique anteriorization and Inferior oblique anteriorization together with unliateral resction in people with Dissociated Vertical Deviation and Inferior Oblique Overaction, run by Kasr El Aini Hospital at 1 site in Egypt.
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 3 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 8 Aug 2023. 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 Egypt. 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?
reduction of the magnitude of DVD (time frame: 1 week ,1 month, three months, six months). 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 8 Aug 2023.