Intraocular Pressure LowNCT03266406
Effect of Hyaluronidase on Intraocular Pressure
A study testing Hyaluronidase in people with Intraocular Pressure Low, run by Assiut University.
Trial summary
The aim of this study is to evaluate effect of retrobulbar local anaesthesia after addition of hyaluronidase on IOP during cataract surgery Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Intraocular Pressure Low
- What is being tested?
- Hyaluronidase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Oct 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1-Patients above the age of 50 years. 2-Patients with age related cataract. 3-Normal IOP.
Who cannot join
- 1History of trauma. 2-Patients with glaucoma. 3-Previous ocular surgery. 4-Patients with other ocular pathology. 5-Uncontrolled diabetes or hypertension. 6-hypersensitivity to lignocaine. 7-Uncooperative or epileptic patients.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Hyaluronidase on Intraocular Pressure After Retrobulbar Anaesthesia During Cataract Surgery
The aim of this study is to evaluate effect of retrobulbar local anaesthesia after addition of hyaluronidase on IOP during cataract surgery
- Conditions
- Intraocular Pressure Low
- Being tested
- Hyaluronidase
- Medical subject headings
- Ocular Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyaluronidaseDrug
4ml of retrobulbar LA with addition of 15IU/ml hyaluronidase to 2% lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Effect of hyaluronidase on IOP | Experimental | Not described Receives: Drug: Hyaluronidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in IOP
reduction of complications of high IOP during surgery
Measured: within 10minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study startSep 2017 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular Pressure LowStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Yassin Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266406
- Sponsor's protocol ID
- effect of hyaluronidase on IOP
- Status last verified
- Aug 2017
- First submitted
- 28 Aug 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyaluronidase on Intraocular Pressure After Retrobulbar Anaesthesia During Cataract Surgery
- ClinicalTrials.gov ID
- NCT03266406
- Acronym / sponsor ID
- effect of hyaluronidase on IOP
- Conditions
- Intraocular Pressure Low
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 30 Aug 2017 (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 aim of this study is to evaluate effect of retrobulbar local anaesthesia after addition of hyaluronidase on IOP during cataract surgery
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effect of hyaluronidase on IOP | Experimental | Drug: Hyaluronidase |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1-Patients above the age of 50 years. 2-Patients with age related cataract. 3-Normal IOP.
Key exclusion criteria (1 listed)
- 1History of trauma. 2-Patients with glaucoma. 3-Previous ocular surgery. 4-Patients with other ocular pathology. 5-Uncontrolled diabetes or hypertension. 6-hypersensitivity to lignocaine. 7-Uncooperative or epileptic patients.
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 |
|---|---|---|
| Hyaluronidase4ml of retrobulbar LA with addition of 15IU/ml hyaluronidase to 2% lidocaine | Drug | Effect of hyaluronidase on IOP |
Primary outcome
reduction in IOP
Time frame: within 10minutes
reduction of complications of high IOP during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronidase in people with Intraocular Pressure Low, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Yassin (00201004686028, emanyassin08@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in IOP (time frame: within 10minutes). 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 30 Aug 2017.