NCT06102265

Brief Summary

Although postoperative infectious endophthalmitis and toxic anterior segment syndrome (TASS) rarely happen, they can threaten sight and are considered complications of intraocular and cataract surgery1. Reusing surgical supplies during cataract surgery, especially in developing countries, will have a treble impact in lowering the financial costs of surgery, the emissions of greenhouse gas, and environmental waste. Nearly half the waste of cataract surgery is recyclable, as reported by a prospective Malaysian study 8. Despite the increasing evidence of reusing the operative supplies, numerous healthcare professionals may be reluctant to consider it due to worries about cross-contamination among patients2. According to the Aravind Eye Care System (AECS) in Tamil Nadu, India, endophthalmitis rated 0.02% in over a million consecutive cataract cases despite the observation that cannulas, irrigation/ aspiration tubing, gowns, surgical gloves, irrigating bottles, as well as topical and intraocular drugs are normally recycled to cut cost and waste3,4. On the other hand, health care plays a key role in climate change, as well as financial and environmental waste2. Cataracts are the leading cause of blindness and visual impairment worldwide, making cataract surgery one of the most performed surgical procedures5. The carbon footprint of cataract surgery, especially phacoemulsification, is a significant research field6-8. In the United Kingdom, cataract surgery releases 180 kg of CO2- equivalents per eye, causing over half of the emissions due to obtaining large disposable medical equipment9. In ACES, phacoemulsification generated 5.9 kg of carbon emissions4. In comparison to the United Kingdom and the United States of America, the cataract surgery's low rates of infection in AECS were accomplished with 1/10 supply costs and 1/20 global warming emissions6. Being the most performed operation, cataract surgery and ophthalmology, in general, can meaningfully influence lowering environmental and economic waste in their surgical services1. The aim of this work is to show if reusing the operative supplies to reduce financial costs, especially in developing countries, and to lower global warming and climate change will affect the rate of postoperative endophthalmitis after cataract surgery

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

October 22, 2023

Last Update Submit

October 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • postoperative complications

    rate of occurence of infection

    6 months

Study Arms (2)

group 1

In one arm of the study group, the surgeon changed the gown and the glove between each case with hand sterilization with alcohol before and after wearing the next glove. Each keratome and MVR were used for multiple patients until they became blunt. We used the same IOL cartridge for every three cases and the same OVD in multiple patients. We immersed keratome, MVR, IOL cartridge, and cannulas of OVD in alcohol between cases. As regard the phaco machine, we used Alcon Infiniti and Alcon Centurion and the same tip for all cases. The tip was immersed in a test chamber filled with alcohol between cases and not changed until we noticed a morphological change or they became blunt. Also, the same cassette was used in multiple surgeries and changed after collecting the plastic bag full of fluid.

Procedure: sterilization

group 2

In another arm, we used the same steps except that the surgeon changed the glove only and used alcohol for hand sterilization before and after wearing the next glove. One gown was used for all the cases. As regard the intracameral antibiotic prophylaxis, a bottle of Vigamox, 5ml, was withdrawn, and each 1 ml was diluted with 5 ml saline. Using this dilution, 0.1 ml was injected intracamerally at the end of the operation. Finally, we did corneal hydration of the main wound and the side ports.

Procedure: sterilization

Interventions

sterilizationPROCEDURE

the use of sterilization methods and the reuse of gowns

group 1group 2

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with cataract subjected to phcoemulsification

You may qualify if:

  • adults with cataract not diabetics not hypertensive

You may not qualify if:

  • youngs diabetics hypertensive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sohag University

Sohag, 82524, Egypt

RECRUITING

Hany Mahmoud

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Eye Diseases

Interventions

Sterilization

Intervention Hierarchy (Ancestors)

Infection ControlCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ophthalmology lecturer

Study Record Dates

First Submitted

October 22, 2023

First Posted

October 26, 2023

Study Start

August 1, 2023

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

October 26, 2023

Record last verified: 2023-10

Locations