CataractNCT07567118
A Study Comparing Sub-Tenon Steroid Injection Versus Eye Drops for Reducing Postoperative Inflammation After Cataract Surgery
A study testing Triamcinolone acetonide injection and prednisolone acetate 1% in people with Cataract and Inflamation, run by Damascus University at 1 site in Syria.
Trial summary
After cataract surgery, postoperative inflammation is commonly treated with corticosteroid eye drops such as prednisolone acetate 1%. However, frequent dosing may reduce patient compliance. Read more about this study
- Who is it for?
- Ages 52 to 76 years
- Conditions the study is for
- Cataract, Inflamation, Phacoemulsification
- What is being tested?
- Triamcinolone acetonide injection and prednisolone acetate 1%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSyria
- Study dates
- 1 May 2023to 2 Feb 2025
- Phase
- Interventional
- 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 52 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for senile cataract surgery meeting the following conditions:
- Best-corrected visual acuity less than or equal to 0.5. Nuclear sclerosis grades NC1, NC2, NC3, or NC4 according to LOCS III, regardless of the grade of cortical or posterior subcapsular cataract.
- Age 50 years and older.
Who cannot join
- Patients with non-age-related cataracts (congenital, infantile, or drug-induced).
- Patients with a history of previous intraocular surgery. Patients with any form of glaucoma. Patients with pseudoexfoliation syndrome. Patients with diabetes mellitus. Patients with uveitis. Patients scheduled for concurrent intraocular surgery at the time of cataract extraction (e.g., trabeculectomy or vitrectomy).
- Patients using long-term topical ocular medications. Patients with only one functional eye. Patients with poor pupil dilation, defined as a pupil diameter of 5.5 mm or less, those requiring iris dilators, or those who experienced iris trauma during surgery.
- Effective phacoemulsification time (EPT) exceeding 2 minutes. Patients who were non-compliant with follow-up visits. Patients who developed postoperative complications unrelated to the study treatment (such as endophthalmitis or intraocular lens dislocation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Of The Safety And Efficacy Of Intraoperative Subtenon Triamcinolone Acetonide Injection Versus Topical Prednisolone Acetate 1% In Reducing Postoprerative Inflammation After Phacoemulsification
After cataract surgery, postoperative inflammation is commonly treated with corticosteroid eye drops such as prednisolone acetate 1%. However, frequent dosing may reduce patient compliance. This study compares topical corticosteroid drops with a single sub-Tenon's injection of triamcinolone acetonide in controlling postoperative inflammation after uncomplicated cataract surgery.
Read the detailed description
Background: Postoperative ocular inflammation is a common physiological response following cataract surgery; however, excessive inflammation may compromise visual outcomes. Topical corticosteroids, particularly prednisolone acetate 1%, remain the standard treatment, but their use is limited by poor patient compliance and the need for frequent dosing. Sub-Tenon's corticosteroid injection offers a potential alternative with a prolonged anti-inflammatory effect.
Objective: To compare the safety and efficacy of a single sub-Tenon's injection of triamcinolone acetonide versus topical prednisolone acetate 1% in controlling postoperative inflammation after uncomplicated cataract surgery.
Methods: This prospective, randomized, interventional comparative study included 72 patients undergoing phacoemulsification surgery. Participants were randomly assigned into two groups: Group 1 received topical prednisolone acetate 1% according to a tapering regimen, while Group 2 received a single sub-Tenon's injection of triamcinolone acetonide (40 mg/mL).
- Conditions
- Cataract, Inflamation, Phacoemulsification
- Being tested
- Triamcinolone acetonide injection, prednisolone acetate 1%
- Keywords
- Cataract surgery, sub-Tenon's injection, triamcinolone acetonide
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone acetonide injectionDrug
Patients in this group received an intraoperative subtenon injection of triamcinolone acetonide at the end of phacoemulsification surgery. The injection was administered to reduce postoperative inflammation.
prednisolone acetate 1%Drug
Patients in this group received topical prednisolone acetate 1% eye drops postoperatively according to the standard regimen to control inflammation after phacoemulsification surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Subtenon Triamcinolone Acetonide | Experimental | Not described Receives: Drug: Triamcinolone acetonide injection |
| Topical Prednisolone Acetate 1% | Active comparator | Not described Receives: Drug: prednisolone acetate 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of postoperative ocular inflammation assessed by slit-lamp examination (cells and flare grading) after phacoemulsification surgery.
Measured: 1day, 1week, 2week, 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start1 May 2023
- Primary completion6 Jan 2025
- Study completion2 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Issa, Damascus University
- Investigators
- sameh Kh issa, professor, Principal investigator, University of Damascus, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567118
- Sponsor's protocol ID
- Damascus-Ophth.
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Of The Safety And Efficacy Of Intraoperative Subtenon Triamcinolone Acetonide Injection Versus Topical Prednisolone Acetate 1% In Reducing Postoprerative Inflammation After Phacoemulsification
- ClinicalTrials.gov ID
- NCT07567118
- Acronym / sponsor ID
- Damascus-Ophth.
- Conditions
- Cataract, Inflamation, Phacoemulsification
- Keywords
- Cataract surgery, sub-Tenon's injection, triamcinolone acetonide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 5 May 2026 (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.
After cataract surgery, postoperative inflammation is commonly treated with corticosteroid eye drops such as prednisolone acetate 1%. However, frequent dosing may reduce patient compliance. This study compares topical corticosteroid drops with a single sub-Tenon's injection of triamcinolone acetonide in controlling postoperative inflammation after uncomplicated cataract surgery.
Detailed description
Background: Postoperative ocular inflammation is a common physiological response following cataract surgery; however, excessive inflammation may compromise visual outcomes. Topical corticosteroids, particularly prednisolone acetate 1%, remain the standard treatment, but their use is limited by poor patient compliance and the need for frequent dosing. Sub-Tenon's corticosteroid injection offers a potential alternative with a prolonged anti-inflammatory effect.
Objective: To compare the safety and efficacy of a single sub-Tenon's injection of triamcinolone acetonide versus topical prednisolone acetate 1% in controlling postoperative inflammation after uncomplicated cataract surgery.
Methods: This prospective, randomized, interventional comparative study included 72 patients undergoing phacoemulsification surgery. Participants were randomly assigned into two groups: Group 1 received topical prednisolone acetate 1% according to a tapering regimen, while Group 2 received a single sub-Tenon's injection of triamcinolone acetonide (40 mg/mL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Subtenon Triamcinolone Acetonide | Experimental | Drug: Triamcinolone acetonide injection |
| Topical Prednisolone Acetate 1% | Active comparator | Drug: prednisolone acetate 1% |
Who may qualify
- Ages
- 52 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Best-corrected visual acuity less than or equal to 0.5. Nuclear sclerosis grades NC1, NC2, NC3, or NC4 according to LOCS III, regardless of the grade of cortical or posterior subcapsular cataract.
- Age 50 years and older.
Key exclusion criteria (4 listed)
- Patients with non-age-related cataracts (congenital, infantile, or drug-induced).
- Patients with a history of previous intraocular surgery. Patients with any form of glaucoma. Patients with pseudoexfoliation syndrome. Patients with diabetes mellitus. Patients with uveitis. Patients scheduled for concurrent intraocular surgery at the time of cataract extraction (e.g., trabeculectomy or vitrectomy).
- Patients using long-term topical ocular medications. Patients with only one functional eye. Patients with poor pupil dilation, defined as a pupil diameter of 5.5 mm or less, those requiring iris dilators, or those who experienced iris trauma during surgery.
- Effective phacoemulsification time (EPT) exceeding 2 minutes. Patients who were non-compliant with follow-up visits. Patients who developed postoperative complications unrelated to the study treatment (such as endophthalmitis or intraocular lens dislocation).
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 |
|---|---|---|
| Triamcinolone acetonide injectionPatients in this group received an intraoperative subtenon injection of triamcinolone acetonide at the end of phacoemulsification surgery. The injection was administered to reduce postoperative inflammation. | Drug | Intraoperative Subtenon Triamcinolone Acetonide |
| prednisolone acetate 1%Patients in this group received topical prednisolone acetate 1% eye drops postoperatively according to the standard regimen to control inflammation after phacoemulsification surgery. | Drug | Topical Prednisolone Acetate 1% |
Primary outcome
Degree of postoperative ocular inflammation assessed by slit-lamp examination (cells and flare grading) after phacoemulsification surgery.
Time frame: 1day, 1week, 2week, 1month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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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.
sameh Kh issa, professor principal investigator
University of Damascus, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone acetonide injection and prednisolone acetate 1% in people with Cataract and Inflamation, run by Damascus University at 1 site in Syria.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 5 May 2026. 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 Syria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Degree of postoperative ocular inflammation assessed by slit-lamp examination (cells and flare grading) after phacoemulsification surgery. (time frame: 1day, 1week, 2week, 1month). 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 5 May 2026.