Topical AnaesthesiaPhase 1/2NCT07287683
Evaluation of Postoperative Pain in Cases Undergoing Cataract Surgery Under Topical Versus General Anesthesia
A Phase 1/2 study testing Topical Anaesthesia group and General Anaesthesia group in people with Topical Anaesthesia and General Anesthetic Drug Adverse Reaction, run by Alexandria University at 1 site in Egypt.
Trial summary
Comparison between cataract surgery under local versus general anesthesia regarding postoperative pain, complications and patient satisfaction and need for rescue analgesic intake after surgery The results will be followed up at 24 hrs, 1 week and after one and half month following the surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Topical Anaesthesia, General Anesthetic Drug Adverse Reaction, Cataract
- What is being tested?
- Topical Anaesthesia group and General Anaesthesia group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Apr 2025to 15 Mar 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unilateral cataract planned for surgery under topical or general anesthesia
Who cannot join
- patients under 20 or over 70 years old Eye infection Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Postoperative Pain in Cases Undergoing Cataract Surgery Under Topical Anaesthetic Versus General Anaesthesia
Comparison between cataract surgery under local versus general anesthesia regarding postoperative pain, complications and patient satisfaction and need for rescue analgesic intake after surgery The results will be followed up at 24 hrs, 1 week and after one and half month following the surgery.
Read the detailed description
This prospective randomized controlled study will be carried out on 50 adult patients. Written informed consent will be taken from all prospective cases.
The cases will be selected having (ASA1), (ASA II) or (ASA III) physical status in the age range between 20 and 70 years old with cataract eye disease.
This study will be performed in Alexandria Main University Hospital, Egypt. Patients will be followed up at 24 hours, 1 week, and 6 weeks after surgery.
The following measurements will be recorded
- Pain will be assessed prior to surgery and after surgery using VAS score at 24 hours, 1 week, and 6 weeks after surgery.
- Need for analgesic intake after surgery will be assessed for the first 48 hours
- Complications after surgery as irritation, infection ,and foreign body sensation were assessed
- Patient satisfaction will be assessed.
- Being tested
- Topical Anaesthesia group, General Anaesthesia group
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Anaesthesia groupDrug
Also called Topical group
This group of patients will only receive topical anaesthesia for Cataract surgery
General Anaesthesia groupDrug
General Anaesthesia will be given to this group undergoing cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Group under general anesthesia for cataract surgery | Active comparator | Patients undergoing cataract surgery will receive general Anaesthesia using intravenous injection and inhalational anaesthetics Receives: Drug: General Anaesthesia group |
| Group under topical anaesthesia | Active comparator | Patients will receive topical anaesthesia for cataract surgery Receives: Drug: Topical Anaesthesia group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Postoperative pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: At 24 hours, one week and 6 weeks following surgery
Secondary outcomes (1)
1-complications after surgery 2-Patient satisfaction will be measured using the IOWA Satisfaction with Anaesthesia Scale (ISAS), which ranges from 6 (very satisfied) to 3 or less (dissatisfied).
Complications including hypotension, nausea and allergic reaction will be assessed after surgery and 24 hours later. satisfaction assessment will evaluate patient safety, pain control, comfort, nausea, interaction with the surgical team, willingness to repeat the anaesthetic, and relaxation during and after surgery. Patient satisfaction will be recorded at one week and six weeks postoperatively.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start2 Apr 2025
- Primary completion20 Feb 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Topical AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, radwa saber, Alexandria University
- Investigators
- Radwa S Raslan, PHD, Principal investigator, AMUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287683
- Sponsor's protocol ID
- 0307211
- Status last verified
- Dec 2025
- First submitted
- 21 Sep 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Pain in Cases Undergoing Cataract Surgery Under Topical Anaesthetic Versus General Anaesthesia
- ClinicalTrials.gov ID
- NCT07287683
- Acronym / sponsor ID
- 0307211
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 17 Dec 2025 (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.
Comparison between cataract surgery under local versus general anesthesia regarding postoperative pain, complications and patient satisfaction and need for rescue analgesic intake after surgery The results will be followed up at 24 hrs, 1 week and after one and half month following the surgery.
Detailed description
This prospective randomized controlled study will be carried out on 50 adult patients. Written informed consent will be taken from all prospective cases.
The cases will be selected having (ASA1), (ASA II) or (ASA III) physical status in the age range between 20 and 70 years old with cataract eye disease.
This study will be performed in Alexandria Main University Hospital, Egypt. Patients will be followed up at 24 hours, 1 week, and 6 weeks after surgery.
The following measurements will be recorded
- Pain will be assessed prior to surgery and after surgery using VAS score at 24 hours, 1 week, and 6 weeks after surgery.
- Need for analgesic intake after surgery will be assessed for the first 48 hours
- Complications after surgery as irritation, infection ,and foreign body sensation were assessed
- Patient satisfaction will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group under general anesthesia for cataract surgery | Active comparator | Drug: General Anaesthesia groupPatients undergoing cataract surgery will receive general Anaesthesia using intravenous injection and inhalational anaesthetics |
| Group under topical anaesthesia | Active comparator | Drug: Topical Anaesthesia groupPatients will receive topical anaesthesia for cataract surgery |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with unilateral cataract planned for surgery under topical or general anesthesia
Key exclusion criteria (1 listed)
- patients under 20 or over 70 years old Eye infection Patient refusal
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 |
|---|---|---|
| Topical Anaesthesia groupAlso: Topical groupThis group of patients will only receive topical anaesthesia for Cataract surgery | Drug | Group under topical anaesthesia |
| General Anaesthesia groupGeneral Anaesthesia will be given to this group undergoing cataract surgery | Drug | Group under general anesthesia for cataract surgery |
Primary outcome
Post operative pain
Time frame: At 24 hours, one week and 6 weeks following surgery
Postoperative pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable).
1 secondary outcome
1-complications after surgery 2-Patient satisfaction will be measured using the IOWA Satisfaction with Anaesthesia Scale (ISAS), which ranges from 6 (very satisfied) to 3 or less (dissatisfied).
Time frame: Up to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Discomfort
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.
Radwa S Raslan, PHD principal investigator
AMUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Topical Anaesthesia group and General Anaesthesia group in people with Topical Anaesthesia and General Anesthetic Drug Adverse Reaction, run by Alexandria University at 1 site 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 1 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: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain (time frame: At 24 hours, one week and 6 weeks following surgery). 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 17 Dec 2025.