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CompletedNCT04769856StarvAnxUpdated Sep 12, 2025

Impact of Non-fasting on Anxiety in Cataract Surgery

An interventional study of State-Trait Anxiety Inventory (STAI) scale and Satisfaction scale in Cataract Surgery, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cataract Surgery

Keywords

  • Cataract surgery
  • Anxiety
  • Fasting
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In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 126 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
126 participants (actual)

Study arms

  • Experimental
    Non-fasting group

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

  • Experimental
    Fasting group

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

Interventions

  • OtherState-Trait Anxiety Inventory (STAI) scale

    State-Trait Anxiety Inventory (STAI) scale

  • OtherSatisfaction scale

    Satisfaction scale

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What researchers measure

Primary outcomes

  1. State-Trait Anxiety Inventory (STAI) scale score

    preoperative anxiety level

    Time frame: Baseline (Before surgery)

Secondary outcomes

  1. Incidence of vitreous outbreaks perceived by the operator

    Incidence of vitreous outbreaks perceived by the operator

    Time frame: During surgery

  2. Incidence of capsular ruptures

    Incidence of capsular ruptures

    Time frame: During surgery

  3. Satisfaction scale score

    Satisfaction scale score (scale from 0 to 10)

    Time frame: Immediately after surgery

  4. Incidence of oxygen desaturations

    Incidence of oxygen desaturations (SpO2 \<93%)

    Time frame: During surgery

  5. Proportion of patients who took their usual antihypertensive therapy

    Proportion of patients who took their usual antihypertensive therapy

    Time frame: Baseline (Before surgery)

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Study locations

1 site
  • Service Anesthésie Réanimation chirurgicale, Hôpital Cochin
    Paris, IDF 75014, France
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References and documents

Publications

  • 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. PubMed 28652955 ↗
  • 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. PubMed 24384865 ↗
  • 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. PubMed 8343333 ↗
  • 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. PubMed 11437763 ↗
  • 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. PubMed 29863606 ↗
  • 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. PubMed 35911419 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04769856
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Feb 25, 2021
Start date
May 2, 2021
Primary completion
Nov 2, 2021
Completion
Nov 2, 2021
Last update
Sep 12, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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