Dissociated Vertical DeviationNCT07883681
Comparative Study Of Combined Recession-Resection And Fenestration of Superior Rectus Muscle for Treatment of Dissociated Vertical Deviation
A study testing resection of superior rectus muscle in people with Dissociated Vertical Deviation, run by Assiut University.
Trial summary
Dissociated vertical deviation (DVD) is a slow, disconjugate upward drift of the non-fixating eye, usually with abduction and excyclotorsion, that does not obey Hering's law . It is uncommon in the general population but develops in about half to 90% of children with infantile esotropia . Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Dissociated Vertical Deviation
- What is being tested?
- resection of superior rectus muscle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 day to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Clinically manifest DVD of at least 15 prism diopters (PD) in the more affected eye, by prism and alternate cover test.
- No previous surgery involving the vertical rectus or oblique muscles.
- Parents or legal guardians willing to give written informed consent and to comply with scheduled follow-up.
Who cannot join
- • Significant inferior oblique overaction or oblique dysfunction requiring simultaneous oblique muscle surgery.
- Restrictive or paralytic strabismus, thyroid eye disease, or other orbital pathology affecting motility.
- Craniofacial syndromes with abnormal extraocular muscle anatomy.
- Systemic neuromuscular disease affecting extraocular muscle function.
- Inability to obtain reliable preoperative or postoperative motility measurements due to poor cooperation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Dissociated vertical deviation (DVD) is a slow, disconjugate upward drift of the non-fixating eye, usually with abduction and excyclotorsion, that does not obey Hering's law . It is uncommon in the general population but develops in about half to 90% of children with infantile esotropia . Its cause is uncertain, probably a supranuclear vertical vergence disturbance after early disruption of binocular fusion, which explains its association with infantile esotropia . Non-surgical treatment suits small or well-controlled deviations: refractive correction, amblyopia therapy . Surgery is indicated when the deviation is frequently manifest or cosmetically unacceptable . When inferior oblique overaction coexists, anterior transposition of the inferior oblique is the procedure of choice . In isolated DVD, surgery aims mainly to weaken the superior rectus (SR). Conventional graded SR recession is the most widely used , but large deviations may need 10 mm or more and undercorrection is common . Recession-resection resects part of the muscle then recesses it by a greater amount, raising the weakening effect , while fenestration removes a central block of muscle and tendon near the insertion without sutures and is simpler and faster . Other options are a posterior fixation (Faden) suture and Y-splitting . The evidence is weak: a Cochrane review found the published studies small and retrospective and asked for randomized trials , and the only comparison of three SR techniques allocated patients by deviation size rather than at random . No trial has compared fenestration with recession-resection in children with DVD.
Read the detailed description
Dissociated vertical deviation (DVD) is a slow, disconjugate upward drift of the non-fixating eye, usually with abduction and excyclotorsion, that does not obey Hering's law . It is uncommon in the general population but develops in about half to 90% of children with infantile esotropia . Its cause is uncertain, probably a supranuclear vertical vergence disturbance after early disruption of binocular fusion, which explains its association with infantile esotropia . Non-surgical treatment suits small or well-controlled deviations: refractive correction, amblyopia therapy . Surgery is indicated when the deviation is frequently manifest or cosmetically unacceptable . When inferior oblique overaction coexists, anterior transposition of the inferior oblique is the procedure of choice . In isolated DVD, surgery aims mainly to weaken the superior rectus (SR). Conventional graded SR recession is the most widely used, but large deviations may need 10 mm or more and undercorrection is common . Recession-resection resects part of the muscle then recesses it by a greater amount, raising the weakening effect , while fenestration removes a central block of muscle and tendon near the insertion without sutures and is simpler and faster . Other options are a posterior fixation (Faden) suture and Y-splitting . The evidence is weak: a Cochrane review found the published studies small and retrospective and asked for randomized trials , and the only comparison of three SR techniques allocated patients by deviation size rather than at random . No trial has compared fenestration with recession-resection in children with DVD.
- Conditions
- Dissociated Vertical Deviation
- Being tested
- resection of superior rectus muscle
- Keywords
- DVD
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resection of superior rectus muscleOther
resection of superior oplique muscle
| Study group | Role | What they receive |
|---|---|---|
| conventional SR recession | Active comparator | graded recession of the superior rectus muscle alone, the amount graded to the preoperative DVD by the Tibrewal nomogram Receives: Other: resection of superior rectus muscle |
| SR recession-resection | Active comparator | a 2.5 mm segment of the SR resected, followed by recession of the muscle exceeding the resected length, graded to the preoperative DVD by the Tibrewal nomogram Receives: Other: resection of superior rectus muscle |
| SR fenestration | Active comparator | a central block of the SR muscle and its tendon removed close to the insertion, without disinsertion or scleral sutures, graded to the preoperative DVD Receives: Other: resection of superior rectus muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare success rates in the 3 groups.
Compare success rates in the 3 groups. Success is defined as absence of manifest DVD at final follow up
Measured: 6 months
Secondary outcomes (2)
recurrence at 6 months and reoperation rate.
recurrence at 6 months and reoperation rate.
Measured: 6 months
Torsional outcome
fundus torsion (disc-fovea angle) before and after surgery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
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.
- More trials run by Assiut UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Ahmed Shawki Roshdi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883681
- Sponsor's protocol ID
- Pediatric ophthalmology
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Of Combined Recession-Resection And Fenestration of Superior Rectus Muscle for Treatment of Dissociated Vertical Deviation
- ClinicalTrials.gov ID
- NCT07883681
- Acronym / sponsor ID
- Pediatric ophthalmology
- Conditions
- Dissociated Vertical Deviation
- Keywords
- DVD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 20 Oct 2026 (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.
Dissociated vertical deviation (DVD) is a slow, disconjugate upward drift of the non-fixating eye, usually with abduction and excyclotorsion, that does not obey Hering's law . It is uncommon in the general population but develops in about half to 90% of children with infantile esotropia . Its cause is uncertain, probably a supranuclear vertical vergence disturbance after early disruption of binocular fusion, which explains its association with infantile esotropia . Non-surgical treatment suits small or well-controlled deviations: refractive correction, amblyopia therapy . Surgery is indicated when the deviation is frequently manifest or cosmetically unacceptable . When inferior oblique overaction coexists, anterior transposition of the inferior oblique is the procedure of choice . In isolated DVD, surgery aims mainly to weaken the superior rectus (SR). Conventional graded SR recession is the most widely used , but large deviations may need 10 mm or more and undercorrection is common . Recession-resection resects part of the muscle then recesses it by a greater amount, raising the weakening effect , while fenestration removes a central block of muscle and tendon near the insertion without sutures and is simpler and faster . Other options are a posterior fixation (Faden) suture and Y-splitting . The evidence is weak: a Cochrane review found the published studies small and retrospective and asked for randomized trials , and the only comparison of three SR techniques allocated patients by deviation size rather than at random . No trial has compared fenestration with recession-resection in children with DVD.
Detailed description
Dissociated vertical deviation (DVD) is a slow, disconjugate upward drift of the non-fixating eye, usually with abduction and excyclotorsion, that does not obey Hering's law . It is uncommon in the general population but develops in about half to 90% of children with infantile esotropia . Its cause is uncertain, probably a supranuclear vertical vergence disturbance after early disruption of binocular fusion, which explains its association with infantile esotropia . Non-surgical treatment suits small or well-controlled deviations: refractive correction, amblyopia therapy . Surgery is indicated when the deviation is frequently manifest or cosmetically unacceptable . When inferior oblique overaction coexists, anterior transposition of the inferior oblique is the procedure of choice . In isolated DVD, surgery aims mainly to weaken the superior rectus (SR). Conventional graded SR recession is the most widely used, but large deviations may need 10 mm or more and undercorrection is common . Recession-resection resects part of the muscle then recesses it by a greater amount, raising the weakening effect , while fenestration removes a central block of muscle and tendon near the insertion without sutures and is simpler and faster . Other options are a posterior fixation (Faden) suture and Y-splitting . The evidence is weak: a Cochrane review found the published studies small and retrospective and asked for randomized trials , and the only comparison of three SR techniques allocated patients by deviation size rather than at random . No trial has compared fenestration with recession-resection in children with DVD.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional SR recession | Active comparator | Other: resection of superior rectus musclegraded recession of the superior rectus muscle alone, the amount graded to the preoperative DVD by the Tibrewal nomogram |
| SR recession-resection | Active comparator | Other: resection of superior rectus musclea 2.5 mm segment of the SR resected, followed by recession of the muscle exceeding the resected length, graded to the preoperative DVD by the Tibrewal nomogram |
| SR fenestration | Active comparator | Other: resection of superior rectus musclea central block of the SR muscle and its tendon removed close to the insertion, without disinsertion or scleral sutures, graded to the preoperative DVD |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- • Clinically manifest DVD of at least 15 prism diopters (PD) in the more affected eye, by prism and alternate cover test.
Key exclusion criteria (5 listed)
- • Significant inferior oblique overaction or oblique dysfunction requiring simultaneous oblique muscle surgery.
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 |
|---|---|---|
| resection of superior rectus muscleresection of superior oplique muscle | Other | SR fenestration, SR recession-resection, conventional SR recession |
Primary outcome
Compare success rates in the 3 groups.
Time frame: 6 months
Compare success rates in the 3 groups. Success is defined as absence of manifest DVD at final follow up
2 secondary outcomes
recurrence at 6 months and reoperation rate.
Time frame: 6 months
Torsional outcome
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A study testing resection of superior rectus muscle in people with Dissociated Vertical Deviation, run by Assiut University.
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 5 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: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duaa Mohammed Ali Sayed zidan, Master degree (01061541924, duaazidan75@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare success rates in the 3 groups. (time frame: 6 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 20 Oct 2026.