ClinicalTrials.Veeva

Menu

Topical Jelly and Intracameral Anesthesia Versus Subtenon Anesthesia, in Cataract Surgery

H

Hospital Italiano de Buenos Aires

Status and phase

Withdrawn
Phase 4

Conditions

Cataract Surgery Anesthesia

Treatments

Drug: Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The options for anesthesia in cataract surgery described are: general, regional or local. The local strategy, it may be by periocular blocking(subtenon, peribulbar or retrobulbar), subconjunctival or topical. The risks faced by subconjunctival, peribulbar or retrobulbar, have made subtenon and topical strategies the most used. Likewise, to improve the effectiveness of the topical strategy was added gel topical lidocaine and intracameral dose of lidocaine.

Subtenon and topical anesthesia are two safe strategies and there were performed multiple studies showing that both are effective in controlling pain, but showing a slight superiority of subtenon. This difference does not appear to be clinically significant. In turn, the addition of gel and intracameral anesthesia, improved pain control. However, lack evidence to compare patient preference when using topical gel and intracameral anesthesia versus sub-Tenon anesthesia.

Multiple advantages has the topical anesthesia. Besides being a safe strategy for the patient, offers a rapid visual recovery, no generates blepharoptosis or diplopia postoperatively, subconjunctival hemorrhage and chemosis.

Because of this the investigators plan to conduct a study comparing the efficacy of gel topical and intracameral anesthesia versus subtenon anesthesia in cataract surgery with scleral incision, assessing the patient's preference Hypothesis: Topical administration of lidocaine in gel and intracameral anesthesia is a better strategy that subtenon anesthesia in cataract surgery

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • bilateral cataract

Exclusion criteria

  • refuse to participate, high surgical risk (ASA 4 or 5), allergy to lidocaine or other amide local anesthesics, inability to understand the informed consent, coagulation abnormalities, prior ophthalmologic surgery, small pupil, Fuchs dystrophy, lens luxation, uveitis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

0 participants in 2 patient groups

Topical
Experimental group
Treatment:
Drug: Lidocaine
subtenon
Active Comparator group
Treatment:
Drug: Lidocaine

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems