StrabismusNCT05425589
Adjustable Strabismus Surgery
A study testing Adjustable strabismus surgery in people with Strabismus, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Strabismus, whether congenital or acquired, is a common visual and cosmetic problem, especially for the young. Adjustable suture strabismus surgery is not in vogue in our country. This technique gives the surgeon a second attempt to provide a better outcome for the patients. Read more about this study
- Who is it for?
- Ages 5 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Strabismus
- What is being tested?
- Adjustable strabismus surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2017to 1 Oct 2024
- 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 5 to 69 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Horizontal, vertical and complex strabismus cases (sensory, paralytic, nystagmus, monocular elevation deficit and dissociated vertical/horizontal deviation) were included, along with patients with a previous history of strabismus surgery.
Myasthenia gravis was excluded along with noncooperative children; less than 7 years of age. Those who did not return for a one year follow up also had to be excluded.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Fauji Foundation Hospital
Rawalpindi, Punjab Province, 46000
Sana Nadeem, MBBS, FCPS,, +92515788162 ext. 1455, sana.nadeem@fui.edu.pk
About this study
Strabismus, whether congenital or acquired, is a common visual and cosmetic problem, especially for the young. Adjustable suture strabismus surgery is not in vogue in our country. This technique gives the surgeon a second attempt to provide a better outcome for the patients.
- Conditions
- Strabismus
- Being tested
- Adjustable strabismus surgery
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustable strabismus surgeryProcedure or surgery
Our objective was to assess the long-term success of adjustable suture strabismus surgery in terms of postoperative alignment and complications.
| Study group | Role | What they receive |
|---|---|---|
| Adjustable strabismus surgery | Other | Our objective was to assess the long-term success of adjustable suture strabismus surgery in terms of postoperative alignment and complications. Receives: Procedure: Adjustable strabismus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative alignment
The post-operative alignment at 1 year will be measured and compared with the pre-operative alignment (deviation) to assess success rate.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Oct 2017
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrabismusStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, interventional study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425589
- Sponsor's protocol ID
- FUI/CTR/2022/2
- Status last verified
- Jun 2022
- First submitted
- 29 Mar 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjustable Strabismus Surgery
- ClinicalTrials.gov ID
- NCT05425589
- Acronym / sponsor ID
- FUI/CTR/2022/2
- Conditions
- Strabismus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 21 Jun 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.
Strabismus, whether congenital or acquired, is a common visual and cosmetic problem, especially for the young. Adjustable suture strabismus surgery is not in vogue in our country. This technique gives the surgeon a second attempt to provide a better outcome for the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, interventional study
| Arm | Type | Receives |
|---|---|---|
| Adjustable strabismus surgery | Other | Procedure: Adjustable strabismus surgeryOur objective was to assess the long-term success of adjustable suture strabismus surgery in terms of postoperative alignment and complications. |
Who may qualify
- Ages
- 5 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Adjustable strabismus surgeryOur objective was to assess the long-term success of adjustable suture strabismus surgery in terms of postoperative alignment and complications. | Procedure or surgery | Adjustable strabismus surgery |
Primary outcome
Post-operative alignment
Time frame: 1 year
The post-operative alignment at 1 year will be measured and compared with the pre-operative alignment (deviation) to assess success rate.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjustable strabismus surgery in people with Strabismus, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 21 Jun 2022. 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 Pakistan. 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 Sana Nadeem, MBBS, FCPS, ACMEd (+92515788162 ext. 1455, sana.nadeem@fui.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative alignment (time frame: 1 year). 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 21 Jun 2022.