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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01344252
First Posted: April 29, 2011
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Italiano de Buenos Aires
  Purpose

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


Condition Intervention Phase
Cataract Surgery Anesthesia Drug: Lidocaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topical Jelly and Intracameral Anesthesia Versus Subtenon Anesthesia, in Cataract Surgery: Preference and Surgical Conditions

Resource links provided by NLM:


Further study details as provided by Hospital Italiano de Buenos Aires:

Primary Outcome Measures:
  • number of subjects who prefer topical anesthesia. [ Time Frame: 1 month ]
    The number of subjects who prefer topical anesthesia will measure at the end of the second surgery (1 month)


Secondary Outcome Measures:
  • intraoperative pain [ Time Frame: 1 hour ]
    Amount of pain as verbal analog scale. Be evaluated at the end of surgery


Enrollment: 0
Study Start Date: April 2011
Arms Assigned Interventions
Experimental: Topical Drug: Lidocaine
We will made anesthesia with topical lidocaine and compared with subtenon anesthesia
Active Comparator: subtenon Drug: Lidocaine
We will made anesthesia with topical lidocaine and compared with subtenon anesthesia

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344252


Locations
Argentina
Hospitalitaliano de buenos aires
Caba, Argentina, C1181ACH
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Argentina, C1181ACH
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
  More Information

Responsible Party: Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT01344252     History of Changes
Other Study ID Numbers: 1686
First Submitted: April 26, 2011
First Posted: April 29, 2011
Last Update Posted: March 24, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action