NCT04769856

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 2, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2021

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

January 29, 2021

Last Update Submit

September 5, 2025

Conditions

Cataract Surgery

Keywords

Cataract surgeryAnxietyFasting

Outcome Measures

Primary Outcomes (1)

  • State-Trait Anxiety Inventory (STAI) scale score

    preoperative anxiety level

    Baseline (Before surgery)

Secondary Outcomes (5)

  • Incidence of vitreous outbreaks perceived by the operator

    During surgery

  • Incidence of capsular ruptures

    During surgery

  • Satisfaction scale score

    Immediately after surgery

  • Incidence of oxygen desaturations

    During surgery

  • Proportion of patients who took their usual antihypertensive therapy

    Baseline (Before surgery)

Study Arms (2)

Non-fasting group

EXPERIMENTAL
Other: State-Trait Anxiety Inventory (STAI) scaleOther: Satisfaction scale

Fasting group

EXPERIMENTAL
Other: State-Trait Anxiety Inventory (STAI) scaleOther: Satisfaction scale

Interventions

State-Trait Anxiety Inventory (STAI) scaleOTHER

State-Trait Anxiety Inventory (STAI) scale

Fasting groupNon-fasting group
Satisfaction scaleOTHER

Satisfaction scale

Fasting groupNon-fasting group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Anesthésie Réanimation chirurgicale, Hôpital Cochin

Paris, IDF, 75014, France

Location

Related Publications (6)

  • Guerrier G, Bernabei F, Giannaccare G, Vagge A, Bonnet C, Baillard C, Monnet D, Rothschild PR. The StarvAnx Study-Comparison Between the Effects of Non-fasting Vs. Fasting Strategy on Surgical Outcomes, Anxiety and Pain in Patients Undergoing Cataract Surgery Under Topical Anesthesia: A Randomized, Crossover, Controlled Trial. Front Med (Lausanne). 2022 Jul 13;9:916225. doi: 10.3389/fmed.2022.916225. eCollection 2022.

    PMID: 35911419BACKGROUND

  • Chon T, Ma A, Mun-Price C. Perioperative Fasting and the Patient Experience. Cureus. 2017 May 24;9(5):e1272. doi: 10.7759/cureus.1272.

    PMID: 28652955BACKGROUND

  • Ogino Y, Kakeda T, Nakamura K, Saito S. Dehydration enhances pain-evoked activation in the human brain compared with rehydration. Anesth Analg. 2014 Jun;118(6):1317-25. doi: 10.1213/ANE.0b013e3182a9b028.

    PMID: 24384865BACKGROUND

  • Maltby JR, Hamilton RC. Preoperative fasting guidelines for cataract surgery under regional anaesthesia. Br J Anaesth. 1993 Jul;71(1):167. doi: 10.1093/bja/71.1.167-a. No abstract available.

    PMID: 8343333BACKGROUND

  • Steeds C, Mather SJ. Fasting regimens for regional ophthalmic anaesthesia. A survey of members of the British Ophthalmic Anaesthesia Society. Anaesthesia. 2001 Jul;56(7):638-42. doi: 10.1046/j.1365-2044.2001.02116.x.

    PMID: 11437763BACKGROUND

  • Seet E, Kumar CM, Eke T, Joshi GP. Starving Patients Before Cataract Surgery Under Regional Anesthesia: Needed or Not? Anesth Analg. 2018 Dec;127(6):1448-1451. doi: 10.1213/ANE.0000000000003504. No abstract available.

    PMID: 29863606BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersFasting

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Mental DisordersFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 25, 2021

Study Start

May 2, 2021

Primary Completion

November 2, 2021

Study Completion

November 2, 2021

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations

FR(1)