ComplicationsNCT01435876
Surgery and Convergence Insufficiency Intermittent Exotropia
A study testing Post exercise Surgery, Orthoptics and Postop orthoptics in people with Complications, run by Sudhalkar Eye Hospital at 3 sites in India.
Trial summary
This trial aims to determine which treatment modality is better for treatment of the convergence insufficiency subtype of intermittent exotropia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complications
- What is being tested?
- Post exercise Surgery, Orthoptics and Postop orthoptics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 3 sitesIndia
- Study dates
- May 2006to May 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Amblyopia
- Anisometropia > 2.5D
- Vertical deviations
Trial locations and contacts
3 sites in 1 country.
India3 sites
Aditya Sudhalkar
Ahmedabad, Gujarat, 380016
M & J Institute Of Ophthalmology
Ahmedabad, Gujarat, 380016
M & J Institute
Ahmedabad, Gujarat, 380016
About this study
Official title: Treatment for Convergence Insufficiency Intermittent Exotropia; A Randomized Trial
This trial aims to determine which treatment modality is better for treatment of the convergence insufficiency subtype of intermittent exotropia.
Read the detailed description
Surgery can give better results,
- Conditions
- Complications
- Being tested
- Post exercise Surgery, Orthoptics, Postop orthoptics, Post exercises surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post exercise SurgeryProcedure or surgery
Also called Accomodative therapy
ORTHOPTICS/MINUS LENS THERAPY
OrthopticsProcedure or surgery
Also called MINUS LENS THERAPY/ORTHOPTICS
MINUS LENS THERAPY/ ORTHOPTICS
Postop orthopticsProcedure or surgery
Also called Minus Lens Therapy
ORTHOPTICS/MINUS LENS THERAPY
Post exercises surgeryProcedure or surgery
Also called Minus Lens Therapy
UNIOCULAR/BINOCULAR RECESSION/RESECTION
| Study group | Role | What they receive |
|---|---|---|
| Surgical arm | Active comparator | UNIOCULAR/BINOCULAR RECESSION/RESECTION PROCEDURES Receives: Procedure: Post exercise Surgery |
| Exercises | Active comparator | ORTHOPTICS/MINUS LENS THERAPY Receives: Procedure: Orthoptics |
| Postoperative Exercises | Active comparator | POST SURGICAL ORTHOPTICS/MINUS LENS Receives: Procedure: Postop orthoptics |
| Surgical | Active comparator | Not described Receives: Procedure: Post exercises surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative gain of stereopsis
Measured: 1month-1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startMay 2006
- Primary completionMay 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplicationsStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sudhalkar Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aditya Sudhalkar, Sudhalkar Eye Hospital
- Investigators
- Aditya A Sudhalkar, M.S., Principal investigator, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435876
- Sponsor's protocol ID
- 12132EH
- Status last verified
- Sep 2011
- First submitted
- 13 Sep 2011
- Last updated
- 19 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Convergence Insufficiency Intermittent Exotropia; A Randomized Trial
- ClinicalTrials.gov ID
- NCT01435876
- Acronym / sponsor ID
- 12132EH
- Conditions
- Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Sudhalkar Eye HospitalUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 19 Sep 2011 (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.
This trial aims to determine which treatment modality is better for treatment of the convergence insufficiency subtype of intermittent exotropia.
Detailed description
Surgery can give better results,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Surgical arm | Active comparator | Procedure: Post exercise SurgeryUNIOCULAR/BINOCULAR RECESSION/RESECTION PROCEDURES |
| Exercises | Active comparator | Procedure: OrthopticsORTHOPTICS/MINUS LENS THERAPY |
| Postoperative Exercises | Active comparator | Procedure: Postop orthopticsPOST SURGICAL ORTHOPTICS/MINUS LENS |
| Surgical | Active comparator | Procedure: Post exercises surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Amblyopia
- Anisometropia > 2.5D
- Vertical deviations
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 |
|---|---|---|
| Post exercise SurgeryAlso: Accomodative therapyORTHOPTICS/MINUS LENS THERAPY | Procedure or surgery | Surgical arm |
| OrthopticsAlso: MINUS LENS THERAPY/ORTHOPTICSMINUS LENS THERAPY/ ORTHOPTICS | Procedure or surgery | Exercises |
| Postop orthopticsAlso: Minus Lens TherapyORTHOPTICS/MINUS LENS THERAPY | Procedure or surgery | Postoperative Exercises |
| Post exercises surgeryAlso: Minus Lens TherapyUNIOCULAR/BINOCULAR RECESSION/RESECTION | Procedure or surgery | Surgical |
Primary outcome
Postoperative gain of stereopsis
Time frame: 1month-1 year
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 19 Sep 2011.
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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.
Aditya A Sudhalkar, M.S. principal investigator
Consultant
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post exercise Surgery, Orthoptics and Postop orthoptics in people with Complications, run by Sudhalkar Eye Hospital at 3 sites in India.
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 0 inclusion and 3 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 19 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. 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?
Postoperative gain of stereopsis (time frame: 1month-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 19 Sep 2011.