OCTA Changes With Local AnesthesiaNCT07298746
Oct Angiography Changes After Local Anesthesia in Cataract Surgery
A study testing Local Anesthesia (peribular injection of both lidocaine 2 % and hyaluronidase 150IU\ML), Local Anesthesia (peribulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML) and Local Anesthesia (retrobulbar anesthesia injection of lidocaine 2 % and hyaluronidase 150IU\ML) in people with OCTA Changes With Local Anesthesia, run by Sohag University.
Trial summary
Assessement of retinal microvasculature detected by OCT-angio after peribulbar \&retrobulbar anesthesia in cases undergoing cataract surgery . Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- OCTA Changes With Local Anesthesia
- What is being tested?
- Local Anesthesia (peribular injection of both lidocaine 2 % and hyaluronidase 150IU\ML), Local Anesthesia (peribulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML) and Local Anesthesia (retrobulbar anesthesia injection of lidocaine 2 % and hyaluronidase 150IU\ML)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Mar 2027
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 40-80 years.
- patients with elective cataract surgery requiring regional block.
Who cannot join
- 1.Allergy to study drugs. 2. Media opacities affecting OCT imaging (corneal pathologies, dense cataracts, vitreous.
- opacities, etc). 3. Patients with any other retinal vascular diseases (retinal vein occlusion, central serous chorioretinopathy, age-related macular degeneration, etc).
- 4. Patients who have had previous intravitreal injections or Laser treatment. 5. Patients who underwent previous vitreoretinal surgeries. 6. Patients with uncontrolled glaucoma or ocular inflammations (eg: vitritis). 7.Patients with diabetes mellitus or hypertension.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mohamed Anber Abdellatif, professor contact
About this study
Official title: OCT Angiography Changes of Retinal Microvasculature After Local Anesthesia in Cases Undergoing Cataract Surgery
Assessement of retinal microvasculature detected by OCT-angio after peribulbar \&retrobulbar anesthesia in cases undergoing cataract surgery .
Read the detailed description
prospective , interventional,comparative , clinical study utilizing a pre-post, within-subject design ,which will be conducted in the Department of Ophthalmology ,Sohag University Hospital ,Egypt.
Optical coherence tomography angiography (OCTA) will be performed before and after the administration of retrobulbar and peribulbar local anesthesia in the same cohort of patients, in order to evaluate the immediate effects of the anesthetic intervention on retinal microvascular parameters.the study will be conducted on patients aged 40-80 years with elective cataract surgery requiring regional block.the study will be divided into two main groups :
- Group with peribulbar anesthesia injection.
- Group with retrobulbar anesthesia injection.
- Conditions
- OCTA Changes With Local Anesthesia
- Being tested
- Local Anesthesia (peribular injection of both lidocaine 2 % and hyaluronidase 150IU\ML), Local Anesthesia (peribulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML), Local Anesthesia (retrobulbar anesthesia injection of lidocaine 2 % and hyaluronidase 150IU\ML), local Anesthesia (retrobulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML)
- Keywords
- OCTA , local anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Anesthesia (peribular injection of both lidocaine 2 % and hyaluronidase 150IU\ML)Drug
peribular injection of both lidocaine 2 % and hyaluronidase 150IU\ML
Local Anesthesia (peribulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML)Drug
peribulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML
Local Anesthesia (retrobulbar anesthesia injection of lidocaine 2 % and hyaluronidase 150IU\ML)Drug
retrobulbar anesthesia injection of lidocaine 2 % and hyaluronidase 150IU\ML
local Anesthesia (retrobulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML)Drug
retrobulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | peribulbar anesthesia injection of two anesthetic agents ( lidocaine 2 %+ hyaluronidase 150IU\ML ) Receives: Drug: Local Anesthesia (peribular injection of both lidocaine 2 % and hyaluronidase 150IU\ML) |
| group A1 | Active comparator | peribulbar anesthesia injection ( mepivacaine 2% + hyaluronidase 150IU\ML ) Receives: Drug: Local Anesthesia (peribulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML) |
| group B | Active comparator | retrobulbar anesthesia injection ( lidocaine 2 %+ hyaluronidase 150IU\ML ) Receives: Drug: Local Anesthesia (retrobulbar anesthesia injection of lidocaine 2 % and hyaluronidase 150IU\ML) |
| group B1 | Active comparator | retrobulbar anesthesia injection ( mepivacaine 2% + hyaluronidase 150IU\ML ) Receives: Drug: local Anesthesia (retrobulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular superficial capillary plexus (SCP) and deep capillary plexus (DCP
to detect degree of changes in vessel density at superficial and deep macular plexuses before and after injection of each group of anesthesia
Measured: ntervention & data collection :4-6 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OCTA Changes With Local AnesthesiaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Aldesoky Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298746
- Sponsor's protocol ID
- Soh-Med-25-9-22MS
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali H, Eissa S, Magdy H, Khashba M. Dexmedetomidine as an Additive to Local Anesthesia for Decreasing Intraocular Pressure in Glaucoma Surgery: A Randomized Trial. Anesth Pain Med. 2020 Jun 27;10(3):e100673. doi: 10.5812/aapm.100673. eCollection 2020 Jun.
PubMed 32944557Rao HL, Pradhan ZS, Suh MH, Moghimi S, Mansouri K, Weinreb RN. Optical Coherence Tomography Angiography in Glaucoma. J Glaucoma. 2020 Apr;29(4):312-321. doi: 10.1097/IJG.0000000000001463.
PubMed 32053551Kalra G, Zarranz-Ventura J, Chahal R, Bernal-Morales C, Lupidi M, Chhablani J. Optical coherence tomography (OCT) angiolytics: a review of OCT angiography quantitative biomarkers. Surv Ophthalmol. 2022 Jul-Aug;67(4):1118-1134. doi: 10.1016/j.survophthal.2021.11.002. Epub 2021 Nov 5.
PubMed 34748794
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT Angiography Changes of Retinal Microvasculature After Local Anesthesia in Cases Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT07298746
- Acronym / sponsor ID
- Soh-Med-25-9-22MS
- Conditions
- OCTA Changes With Local Anesthesia
- Keywords
- OCTA , local anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Dec 2025 (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.
Assessement of retinal microvasculature detected by OCT-angio after peribulbar \&retrobulbar anesthesia in cases undergoing cataract surgery .
Detailed description
prospective , interventional,comparative , clinical study utilizing a pre-post, within-subject design ,which will be conducted in the Department of Ophthalmology ,Sohag University Hospital ,Egypt.
Optical coherence tomography angiography (OCTA) will be performed before and after the administration of retrobulbar and peribulbar local anesthesia in the same cohort of patients, in order to evaluate the immediate effects of the anesthetic intervention on retinal microvascular parameters.the study will be conducted on patients aged 40-80 years with elective cataract surgery requiring regional block.the study will be divided into two main groups :
- Group with peribulbar anesthesia injection.
- Group with retrobulbar anesthesia injection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: Local Anesthesia (peribular injection of both lidocaine 2 % and hyaluronidase 150IU\ML)peribulbar anesthesia injection of two anesthetic agents ( lidocaine 2 %+ hyaluronidase 150IU\ML ) |
| group A1 | Active comparator | Drug: Local Anesthesia (peribulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML)peribulbar anesthesia injection ( mepivacaine 2% + hyaluronidase 150IU\ML ) |
| group B | Active comparator | Drug: Local Anesthesia (retrobulbar anesthesia injection of lidocaine 2 % and hyaluronidase 150IU\ML)retrobulbar anesthesia injection ( lidocaine 2 %+ hyaluronidase 150IU\ML ) |
| group B1 | Active comparator | Drug: local Anesthesia (retrobulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML)retrobulbar anesthesia injection ( mepivacaine 2% + hyaluronidase 150IU\ML ) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 40-80 years.
- patients with elective cataract surgery requiring regional block.
Key exclusion criteria (3 listed)
- 1.Allergy to study drugs. 2. Media opacities affecting OCT imaging (corneal pathologies, dense cataracts, vitreous.
- opacities, etc). 3. Patients with any other retinal vascular diseases (retinal vein occlusion, central serous chorioretinopathy, age-related macular degeneration, etc).
- 4. Patients who have had previous intravitreal injections or Laser treatment. 5. Patients who underwent previous vitreoretinal surgeries. 6. Patients with uncontrolled glaucoma or ocular inflammations (eg: vitritis). 7.Patients with diabetes mellitus or hypertension.
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 |
|---|---|---|
| Local Anesthesia (peribular injection of both lidocaine 2 % and hyaluronidase 150IU\ML)peribular injection of both lidocaine 2 % and hyaluronidase 150IU\ML | Drug | group A |
| Local Anesthesia (peribulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML)peribulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML | Drug | group A1 |
| Local Anesthesia (retrobulbar anesthesia injection of lidocaine 2 % and hyaluronidase 150IU\ML)retrobulbar anesthesia injection of lidocaine 2 % and hyaluronidase 150IU\ML | Drug | group B |
| local Anesthesia (retrobulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML)retrobulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML | Drug | group B1 |
Primary outcome
Macular superficial capillary plexus (SCP) and deep capillary plexus (DCP
Time frame: ntervention & data collection :4-6 monthes
to detect degree of changes in vessel density at superficial and deep macular plexuses before and after injection of each group of anesthesia
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 23 Dec 2025.
- Results publication: PubMed 32944557Ali H, Eissa S, Magdy H, Khashba M. Dexmedetomidine as an Additive to Local Anesthesia for Decreasing Intraocular Pressure in Glaucoma Surgery: A Randomized Trial. Anesth Pain Med. 2020 Jun 27;10(3):e100673. doi: 10.5812/aapm.100673. eCollection 2020 Jun.
- Results publication: PubMed 32053551Rao HL, Pradhan ZS, Suh MH, Moghimi S, Mansouri K, Weinreb RN. Optical Coherence Tomography Angiography in Glaucoma. J Glaucoma. 2020 Apr;29(4):312-321. doi: 10.1097/IJG.0000000000001463.
- Results publication: PubMed 34748794Kalra G, Zarranz-Ventura J, Chahal R, Bernal-Morales C, Lupidi M, Chhablani J. Optical coherence tomography (OCT) angiolytics: a review of OCT angiography quantitative biomarkers. Surv Ophthalmol. 2022 Jul-Aug;67(4):1118-1134. doi: 10.1016/j.survophthal.2021.11.002. Epub 2021 Nov 5.
- Individual participant dataSharing planned: No
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.
Mohamed Anber Abdellatif, professor contact
Questions about this trial
What is this clinical trial studying?
A study testing Local Anesthesia (peribular injection of both lidocaine 2 % and hyaluronidase 150IU\ML), Local Anesthesia (peribulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML) and Local Anesthesia (retrobulbar anesthesia injection of lidocaine 2 % and hyaluronidase 150IU\ML) in people with OCTA Changes With Local Anesthesia, run by Sohag 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 2 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: opening soon, as of the sponsor's last update on 23 Dec 2025. 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 Amira aldesoky abdelazeem ahmed, resident (01055330581, amera.desouky@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular superficial capillary plexus (SCP) and deep capillary plexus (DCP (time frame: ntervention & data collection :4-6 monthes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07298746, which also lists 3 linked publications.
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 23 Dec 2025.