Impact of Non-fasting on Anxiety in Cataract Surgery (StarvAnx)

September 5, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Impact of Non-fasting Strategy on Pre-operative Patients' Anxiety in Cataract Surgery Performed Under Topical Anesthesia

The aim of this prospective study was to investigate whether non-fasting recommendation could reduce preoperative anxiety level, incidence of anesthetist interventions, and number of surgical complications in elective cataract surgery patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fear of aspiration makes anesthetists reluctant to challenge standard pre-operative fasting guidelines recommending stopping eating solids and drinking clear fluid 6 hours and 2 hours, respectively before anesthesia. However, hunger and thirst exacerbates patients' anxiety, adversely impacts the patient's comfort and satisfaction, and enhances pain response leading to additional need for analgesia.

Patients undergoing non-invasive procedures requiring no or light sedation may benefit from non-fasting recommendations. The need for preoperative fasting in patients undergoing cataract surgery under topical anesthesia remains controversial. Patients are not fasted before standard cataract surgery under local anesthesia in many cataract centers, in accordance with the UK national guideline published in 2012. However, this practice is not supported by a high level of evidence from prospective clinical trials. So far, the lack of international professional consensus on the matter, local practices are based on institutional recommendations obviating the need for starvation in routine cataract surgery under topical anesthesia.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • IDF
      • Paris, IDF, France, 75014
        • Service Anesthésie Réanimation chirurgicale, Hôpital Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Information and collection of patient consent
  • Age greater than or equal to 18 years
  • Affiliation to a social insurance
  • Undergoing cataract surgery under topical anesthesia
  • Intervention on the 1st eye

Exclusion Criteria:

  • Refusal to participate
  • Language barrier incompatible with the performance of a reliable assessment
  • Behavior disorders
  • Anesthesia other than topical
  • Voluntary control disorder
  • Intervention on the 2nd eye
  • Taking psychotropic drugs.
  • Legal protection regime

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-fasting group
Other: State-Trait Anxiety Inventory (STAI) scale
State-Trait Anxiety Inventory (STAI) scale
Other: Satisfaction scale
Satisfaction scale
Experimental: Fasting group
Other: State-Trait Anxiety Inventory (STAI) scale
State-Trait Anxiety Inventory (STAI) scale
Other: Satisfaction scale
Satisfaction scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State-Trait Anxiety Inventory (STAI) scale score
Time Frame: Baseline (Before surgery)
preoperative anxiety level
Baseline (Before surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of vitreous outbreaks perceived by the operator
Time Frame: During surgery
Incidence of vitreous outbreaks perceived by the operator
During surgery
Incidence of capsular ruptures
Time Frame: During surgery
Incidence of capsular ruptures
During surgery
Satisfaction scale score
Time Frame: Immediately after surgery
Satisfaction scale score (scale from 0 to 10)
Immediately after surgery
Incidence of oxygen desaturations
Time Frame: During surgery
Incidence of oxygen desaturations (SpO2 <93%)
During surgery
Proportion of patients who took their usual antihypertensive therapy
Time Frame: Baseline (Before surgery)
Proportion of patients who took their usual antihypertensive therapy
Baseline (Before surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC Necker Cochin, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2021

Primary Completion (Actual)

November 2, 2021

Study Completion (Actual)

November 2, 2021

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP201410

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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