OphthalmopathyNCT06102265
Effect Of Reusing the Operative Supplies On Cataract Surgery and Climate Change
An observational study of Ophthalmopathy, run by Sohag University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ophthalmopathy
- What is being tested?
- sterilization
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Aug 2023to 1 Nov 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with cataract subjected to phcoemulsification
Who may be able to join
- adults with cataract not diabetics not hypertensive
Who cannot join
- youngs diabetics hypertensive
- -
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Sohag University
Sohag, 82524
Hany Mahmoud, 01024368111, drhanymahmoud@gmail.com
- Recruiting
Hany Mahmoud
Sohag
Hany Mahmoud, MD, 00201024368111, drhanymahmoud@gmail.com
About this study
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.
Read more
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
Read the detailed description
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 Preoperatively, all patients underwent routine systemic examinations, such as blood pressure and blood glucose level measurements, ECG, and hepatitis markers.
No preoperative topical antibiotics prophylaxis was described for all patients. Retrobulbar and peribulbar anesthesia were used for all patients. While performing the anesthesia, a drop of topical anesthesia, a drop of povidone-iodine 5%, and a drop of Moxifloxacin (Vigamox) were installed in the conjunctival cul-de-sac immediately prior to the surgery. Topical povidone-iodine was utilized immediately prior to the surgery in order to prepare the periorbital area (10%). After opening the face drape, a drop of povidone-iodine 5% was also installed in the conjunctival sac and washed thoroughly before starting the operation.
Topical Gatifloxacin (Tymer) and Prednisolone (Optipred)drops were instilled four times daily in the first 10 days following the surgery. Additionally, a topical combination solution of Ofloxacin, dexamethasone (Dexaflox), and a lubricant(Systane) was used three times daily for the next four weeks.
Hand sterilization of the surgeon and the assistant was done once before starting the first case with povidone-iodine and alcohol.
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.
We routinely used intracameral Moxifloxacin (Vigamox) as antibiotic prophylaxis. The bottle of 5ml was withdrawn, put in the irrigating bottle of phacoemulsification, used throughout the operation, and used for multiple patients until the bottle became empty.
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.
- Conditions
- Ophthalmopathy
- Being tested
- sterilization
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sterilizationProcedure or surgery
the use of sterilization methods and the reuse of gowns
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: sterilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
rate of occurence of infection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Aug 2023
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OphthalmopathyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Mahmoud,MD, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102265
- Sponsor's protocol ID
- soh-med-23-10-06PD
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Reusing the Operative Supplies On Cataract Surgery and Climate Change
- ClinicalTrials.gov ID
- NCT06102265
- Acronym / sponsor ID
- soh-med-23-10-06PD
- Conditions
- Ophthalmopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 Preoperatively, all patients underwent routine systemic examinations, such as blood pressure and blood glucose level measurements, ECG, and hepatitis markers.
No preoperative topical antibiotics prophylaxis was described for all patients. Retrobulbar and peribulbar anesthesia were used for all patients. While performing the anesthesia, a drop of topical anesthesia, a drop of povidone-iodine 5%, and a drop of Moxifloxacin (Vigamox) were installed in the conjunctival cul-de-sac immediately prior to the surgery. Topical povidone-iodine was utilized immediately prior to the surgery in order to prepare the periorbital area (10%). After opening the face drape, a drop of povidone-iodine 5% was also installed in the conjunctival sac and washed thoroughly before starting the operation.
Topical Gatifloxacin (Tymer) and Prednisolone (Optipred)drops were instilled four times daily in the first 10 days following the surgery. Additionally, a topical combination solution of Ofloxacin, dexamethasone (Dexaflox), and a lubricant(Systane) was used three times daily for the next four weeks.
Hand sterilization of the surgeon and the assistant was done once before starting the first case with povidone-iodine and alcohol.
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.
We routinely used intracameral Moxifloxacin (Vigamox) as antibiotic prophylaxis. The bottle of 5ml was withdrawn, put in the irrigating bottle of phacoemulsification, used throughout the operation, and used for multiple patients until the bottle became empty.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Procedure: sterilizationIn 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. |
| group 2 | – | Procedure: sterilizationIn 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with cataract subjected to phcoemulsification
Key inclusion criteria (1 listed)
- adults with cataract not diabetics not hypertensive
Key exclusion criteria (2 listed)
- youngs diabetics hypertensive
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sterilizationthe use of sterilization methods and the reuse of gowns | Procedure or surgery | group 1, group 2 |
Primary outcome
postoperative complications
Time frame: 6 months
rate of occurence of infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ophthalmopathy, run by Sohag University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hany Mahmoud (01024368111, drhanymahmoud@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.