CataractNCT05248139
Safety and Effectiveness of Drop-free Small Incision Cataract Surgery
A study testing Intraoperative delivery of medication, Kenalog (Triamcinolone) and Topical post-operative eyedrops, Prednisolone acetate in people with Cataract and Ocular Inflammation, run by Visualiza.
Trial summary
This is a randomized control trial comparing the effects of subconjunctival triamcinolone administration during surgery to topical prednisolone drops on the development of post-operative inflammation and macular edema in manual small incision cataract surgery. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Cataract, Ocular Inflammation, Ocular Hypertension
- What is being tested?
- Intraoperative delivery of medication, Kenalog (Triamcinolone) and Topical post-operative eyedrops, Prednisolone acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Feb 2023
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of a visually significant cataract: nuclear sclerotic, posterior subcapsular and/or cortical
- Best corrected visual acuity or 20/40 or worse
Who cannot join
- Axial length < 20 or > 26 mm
- Cataract which is traumatic, subluxated, or Morgagnian
- Presence of ocular comorbidity: including corneal or retinal abnormalities (corneal opacities, macular degeneration, macular scars, epiretinal membrane, retinal detachment, retinal vascular occlusion), glaucoma, ocular hypertension, glaucoma suspect (cup-to-disc ratio of 0.7 or more, history of steroid response, history of uveitis, pseudoexfoliation
- History of endophthalmitis or macular edema in the fellow eye
- Personal history of diabetes mellitus or uncontrolled hypertension
- Currently pregnant or lactating women
- Current use of systemic steroids for asthma, rheumatoid arthritis or other illness or history of steroid use by any route in the prior 3 months.
- Intraoperative complications including posterior capsular rupture, iris prolapse, zonular dialysis, retained nucleus, vitreous loss, iris trauma resulting in hemorrhage, Descemet dehiscence of more than 1 mm x 1 mm
Trial locations and contacts
No sites are listed yet.
Gena M Damento, MD contact
About this study
Official title: Safety and Effectiveness of Single-dose Subconjunctival Triamcinolone Compared to Topical Prednisolone Eye Drops in Manual Small Incision Cataract Surgery
This is a randomized control trial comparing the effects of subconjunctival triamcinolone administration during surgery to topical prednisolone drops on the development of post-operative inflammation and macular edema in manual small incision cataract surgery.
Read the detailed description
Eye drops given following cataract surgery for prevention of post-operative inflammation carry many disadvantages, such as cost and poor medication adherence. To eliminate these barriers, the emerging technique of single dose of subconjunctival triamcinolone delivered during surgery has been shown an effective and safe alternative. The goal of this study is to build on this evidence, utilizing subconjunctival triamcinolone in conjunction with a different surgical technique and population as what was previously studied. This is a randomized control trial comparing the effects of single-dose subconjunctival triamcinolone administration at the time of surgery to the standard 4-week taper of topical prednisolone drops following manual small incision cataract surgery in Guatemala. Patients will be evaluated at post-operative weeks 6 and 12 with the primary outcome variables of intraocular pressure and best corrected visual acuity. Data on presence and amount of corneal edema, anterior chamber inflammation, and development of macular edema will also be obtained.
- Being tested
- Intraoperative delivery of medication, Kenalog (Triamcinolone), Topical post-operative eyedrops, Prednisolone acetate
- Medical subject headings
- Cataract, Ocular Hypertension, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative delivery of medication, Kenalog (Triamcinolone)Drug
Subconjunctival triamcinolone acetonide 4 mg (0.4 mL of 10 mg/mL solution), single-dose injected 6-8 mm inferior to the inferior limbus with a bent 27-gauge needle at completion of cataract surgery.
Topical post-operative eyedrops, Prednisolone acetateDrug
Standard of care Presnisolone acetate 1% ophthalmic drop taper: 4 times per day for first week, then tapering one drop per week for 3 additional weeks. Discontinued after 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Single-dose steroid medication delivered during surgery | Experimental | Subconjunctival injection of Triamcinolone acetonide. Receives: Drug: Intraoperative delivery of medication, Kenalog (Triamcinolone) |
| Standard of care post-operative steroid drops | Active comparator | Prednisolone acetate ophthalmic solution, 4-week taper. Receives: Drug: Topical post-operative eyedrops, Prednisolone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean post-operative intraocular pressure (IOP) in mmHg in each group
Comparison of mean IOP in mmHg obtained by applanation between control and intervention groups at all time points
Measured: Pre-operative exam through post-operative month week 12
Corrected distance visual acuity (CDVA)
Comparison of visual acuity following refraction quantified on a the logarithm of the minimum angle of resolution (LogMAR) scale with a range from -0.30 (Snellen equivalent 6/3) with exceptional vision to +3.00 which corresponds to poor vision or only able to discriminate hand motions.
Measured: Pre-operative exam through post-operative week 12
Secondary outcomes (2)
Degree of inflammation using anterior chamber (AC) inflammation score
Comparison between groups; score obtained by slit lamp examination by a single, non-operating investigational surgeon at all clinic time points. Patients will receive a number for anterior chamber cell ranging from 0 which equals no inflammatory cells visible to 4, or >50 visible cells in the anterior chamber according to the Standardization of Uveitis Nomenclature (SUN) scoring system. This will then be added to the patient's flare score ranging from 0, or no flare, to 4+, which signifies high levels of inflammation, such as fixed or plastic anterior chamber fluid. The summation of these values will determine the patient's overall anterior inflammation score for that examination date.
Measured: Pre-operative exam through post-operative week 12
Incidence of treatment-emergent macular edema
Incidence of macular edema compared between treatment groups. Macular edema defined as BCVA of 20/40 or worse and ocular coherence tomography with identifiable cystoid spaces within the macula (central 1 mm) or central subfield thickening of 320 µm or greater.
Measured: Post-operative month one through post-operative week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study startOct 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Visualiza
- Sponsor type
- University, hospital or other
- Collaborators
- Seva Foundation
- Responsible party
- Sponsor
- Investigators
- Neal Shorstein, MD, Study chair, Seva Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248139
- Sponsor's protocol ID
- Dropfree MSICS
- Status last verified
- Aug 2022
- First submitted
- 8 Dec 2021
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papa-Vettorazzi R, Shorstein NH, Peterson B, Yee Melgar M, Silva Linares L, O'Brien KS. Comparison of Subconjunctival Triamcinolone with Topical Prednisolone for Routine Anti-Inflammatory Prophylaxis in Manual Small Incision Cataract Surgery: A Single-Center, Randomized Controlled Trial Pilot Protocol. Clin Ophthalmol. 2025 Jul 4;19:2091-2105. doi: 10.2147/OPTH.S527039. eCollection 2025.
PubMed 40630265
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Single-dose Subconjunctival Triamcinolone Compared to Topical Prednisolone Eye Drops in Manual Small Incision Cataract Surgery
- ClinicalTrials.gov ID
- NCT05248139
- Acronym / sponsor ID
- Dropfree MSICS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- VisualizaUniversity, hospital or other
- Collaborators
- Seva Foundation
- Study start
- Oct 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 21 Feb 2022 (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.
This is a randomized control trial comparing the effects of subconjunctival triamcinolone administration during surgery to topical prednisolone drops on the development of post-operative inflammation and macular edema in manual small incision cataract surgery.
Detailed description
Eye drops given following cataract surgery for prevention of post-operative inflammation carry many disadvantages, such as cost and poor medication adherence. To eliminate these barriers, the emerging technique of single dose of subconjunctival triamcinolone delivered during surgery has been shown an effective and safe alternative. The goal of this study is to build on this evidence, utilizing subconjunctival triamcinolone in conjunction with a different surgical technique and population as what was previously studied. This is a randomized control trial comparing the effects of single-dose subconjunctival triamcinolone administration at the time of surgery to the standard 4-week taper of topical prednisolone drops following manual small incision cataract surgery in Guatemala. Patients will be evaluated at post-operative weeks 6 and 12 with the primary outcome variables of intraocular pressure and best corrected visual acuity. Data on presence and amount of corneal edema, anterior chamber inflammation, and development of macular edema will also be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-dose steroid medication delivered during surgery | Experimental | Drug: Intraoperative delivery of medication, Kenalog (Triamcinolone)Subconjunctival injection of Triamcinolone acetonide. |
| Standard of care post-operative steroid drops | Active comparator | Drug: Topical post-operative eyedrops, Prednisolone acetatePrednisolone acetate ophthalmic solution, 4-week taper. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of a visually significant cataract: nuclear sclerotic, posterior subcapsular and/or cortical
- Best corrected visual acuity or 20/40 or worse
Key exclusion criteria (8 listed)
- Axial length < 20 or > 26 mm
- Cataract which is traumatic, subluxated, or Morgagnian
- Presence of ocular comorbidity: including corneal or retinal abnormalities (corneal opacities, macular degeneration, macular scars, epiretinal membrane, retinal detachment, retinal vascular occlusion), glaucoma, ocular hypertension, glaucoma suspect (cup-to-disc ratio of 0.7 or more, history of steroid response, history of uveitis, pseudoexfoliation
- History of endophthalmitis or macular edema in the fellow eye
- Personal history of diabetes mellitus or uncontrolled hypertension
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 |
|---|---|---|
| Intraoperative delivery of medication, Kenalog (Triamcinolone)Subconjunctival triamcinolone acetonide 4 mg (0.4 mL of 10 mg/mL solution), single-dose injected 6-8 mm inferior to the inferior limbus with a bent 27-gauge needle at completion of cataract surgery. | Drug | Single-dose steroid medication delivered during surgery |
| Topical post-operative eyedrops, Prednisolone acetateStandard of care Presnisolone acetate 1% ophthalmic drop taper: 4 times per day for first week, then tapering one drop per week for 3 additional weeks. Discontinued after 4 weeks. | Drug | Standard of care post-operative steroid drops |
Primary outcome
Mean post-operative intraocular pressure (IOP) in mmHg in each group
Time frame: Pre-operative exam through post-operative month week 12
Comparison of mean IOP in mmHg obtained by applanation between control and intervention groups at all time points
Corrected distance visual acuity (CDVA)
Time frame: Pre-operative exam through post-operative week 12
Comparison of visual acuity following refraction quantified on a the logarithm of the minimum angle of resolution (LogMAR) scale with a range from -0.30 (Snellen equivalent 6/3) with exceptional vision to +3.00 which corresponds to poor vision or only able to discriminate hand motions.
2 secondary outcomes
Degree of inflammation using anterior chamber (AC) inflammation score
Time frame: Pre-operative exam through post-operative week 12
Incidence of treatment-emergent macular edema
Time frame: Post-operative month one through post-operative week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Derived from this study: PubMed 40630265Papa-Vettorazzi R, Shorstein NH, Peterson B, Yee Melgar M, Silva Linares L, O'Brien KS. Comparison of Subconjunctival Triamcinolone with Topical Prednisolone for Routine Anti-Inflammatory Prophylaxis in Manual Small Incision Cataract Surgery: A Single-Center, Randomized Controlled Trial Pilot Protocol. Clin Ophthalmol. 2025 Jul 4;19:2091-2105. doi: 10.2147/OPTH.S527039. eCollection 2025.
- 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.
Gena M Damento, MD contact
Neal Shorstein, MD study chair
Seva Foundation
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative delivery of medication, Kenalog (Triamcinolone) and Topical post-operative eyedrops, Prednisolone acetate in people with Cataract and Ocular Inflammation, run by Visualiza.
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 2 inclusion and 8 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 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Lucia Silva, MD (50224140880, Lucia.Silva@visualiza.org.gt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean post-operative intraocular pressure (IOP) in mmHg in each group (time frame: Pre-operative exam through post-operative month week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05248139, which also lists 1 linked publication.
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 9 Aug 2022.