Oct Angiography Changes After Local Anesthesia in Cataract Surgery

Sohag University

Status: Not yet enrolling

Conditions: OCTA Changes With Local Anesthesia

Treatments: Drug: Local Anesthesia (peribulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML); Drug: local Anesthesia (retrobulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML); Drug: Local Anesthesia (peribular injection of both lidocaine 2 % and hyaluronidase 150IU\ML); Drug: Local Anesthesia (retrobulbar anesthesia injection of lidocaine 2 % and hyaluronidase 150IU\ML)

Study type: Interventional

Funder types: Other

Identifiers

NCT07298746

Soh-Med-25-9-22MS

Details and patient eligibility

About

Assessement of retinal microvasculature detected by OCT-angio after peribulbar &retrobulbar anesthesia in cases undergoing cataract surgery .

Full 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 :

1. Group with peribulbar anesthesia injection.
2. Group with retrobulbar anesthesia injection.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patients aged 40-80 years.
2. patients with elective cataract surgery requiring regional block.

Exclusion criteria

• 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 design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 4 patient groups

group A

Active Comparator group

Description:

peribulbar anesthesia injection of two anesthetic agents ( lidocaine 2 %+ hyaluronidase 150IU\\ML )

Treatment:

Drug: Local Anesthesia (peribular injection of both lidocaine 2 % and hyaluronidase 150IU\ML)

group A1

Active Comparator group

Description:

peribulbar anesthesia injection ( mepivacaine 2% + hyaluronidase 150IU\\ML )

Treatment:

Drug: Local Anesthesia (peribulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML)

group B

Active Comparator group

Description:

retrobulbar anesthesia injection ( lidocaine 2 %+ hyaluronidase 150IU\\ML )

Treatment:

Drug: Local Anesthesia (retrobulbar anesthesia injection of lidocaine 2 % and hyaluronidase 150IU\ML)

group B1

Active Comparator group

Description:

retrobulbar anesthesia injection ( mepivacaine 2% + hyaluronidase 150IU\\ML )

Treatment:

Drug: local Anesthesia (retrobulbar anesthesia injection of mepivacaine 2% and hyaluronidase 150IU\ML)