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Not yet recruiting NCT07298746

Oct Angiography Changes After Local Anesthesia in Cataract Surgery

No phase Interventional OCTA Changes With Local Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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).
Who it may be relevant to
Registry conditions: OCTA Changes With Local Anesthesia. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

OCT Angiography Changes of Retinal Microvasculature After Local Anesthesia in Cases Undergoing Cataract Surgery

Overview

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 :

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

Interventions

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

Primary outcome measures

  • Macular superficial capillary plexus (SCP) and deep capillary plexus (DCP [Time frame: ntervention & data collection :4-6 monthes]

Eligibility criteria

Inclusion criteria

  • patients aged 40-80 years.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 32944557
  • Rao 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. PMID 32053551
  • Kalra 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. PMID 34748794

Identifiers

NCT: NCT07298746 · Soh-Med-25-9-22MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗