CataractEarly Phase 1NCT06539637
Ketorolac Levels in Vitreous and Aqueous Samples From Patients Undergoing Combined Cataract and Pars Plana Vitrectomy Surgeries With and Without Intracameral Phenylephrine 1.0% / Ketorolac 0.3%
A Early Phase 1 study testing OMIDRIA (*Registered Product) {10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac} and Ketorolac Tromethamine {TORADOL} (0.5%) - Topical Eyedrop in people with Cataract, run by DHS Consulting at 1 site in United States.
Trial summary
This is a clinical trial evaluating Ketorolac levels in vitreous and aqueous humor samples from patients undergoing combined cataract and pars plana vitrectomy surgeries with and without intracameral phenylephrine 1.0% / ketorolac 0.3% (OMIDRIA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- OMIDRIA (*Registered Product) {10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac} and Ketorolac Tromethamine {TORADOL} (0.5%) - Topical Eyedrop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to Feb 2026
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent
- Undergoing cataract surgery immediately followed by pars plana vitrectomy
- Diagnosed preoperatively with a structural pathology requiring vitrectomy (e.g., epiretinal membrane, macular hole, and symptomatic vitreous floaters)
- Willing and able to comply with all study procedures
- Male or female, aged ≥ 18 years
Who cannot join
- Age < 18
- Participating in another clinical trial
- Patients undergoing cataract surgery or pars plana vitrectomy alone (not a combined procedure)
- Previous vitrectomy
- Complications at the time of cataract surgery
- A tear in the posterior capsule
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ophthalmic Consultants of Long Island
Westbury, New York, 11590
Eric Donnenfeld, MD, 516-804-5200
Eric Sigler, MD, 516 804 5200
About this study
This is a clinical trial evaluating Ketorolac levels in vitreous and aqueous humor samples from patients undergoing combined cataract and pars plana vitrectomy surgeries with and without intracameral phenylephrine 1.0% / ketorolac 0.3% (OMIDRIA). Patients not receiving intracameral OMIDRIA will receive topical ketorolac prior to cataract surgery/pars plana vitrectomy.
Read the detailed description
Cataract surgery can result in intra- and postoperative inflammation. Various strategies are employed to prevent and combat this inflammatory reaction, including preoperative topical NSAIDs, intraoperative NSAIDs or steroids, and postoperative topical NSAIDs and/or steroids. The only FDA-approved NSAID for intraoperative use is the ketorolac component of OMIDRIA® (Rayner Surgical, Bellevue, WA, USA).
Animal studies have assessed the concentration of ketorolac in the vitreous and demonstrated therapeutic levels out to 10 hours postoperatively. There is no human data for ketorolac levels in the vitreous following intracameral administration of OMIDRIA at the time of cataract surgery.
This study will enroll approximately 10-20 patients undergoing combined cataract surgery immediately followed by pars plana vitrectomy. Aqueous and vitreous samples will be taken intraoperatively and sent to an independent lab for analysis of ketorolac concentrations.
- Conditions
- Cataract
- Being tested
- OMIDRIA (*Registered Product) {10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac}, Ketorolac Tromethamine {TORADOL} (0.5%) - Topical Eyedrop
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMIDRIA (*Registered Product) {10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac}Combination product
10.16 mg/mL (1% w/v) of phenylephrine {Generic Name: Biorphen} (Adrenergic Receptor Agonist) and 2.88 mg/mL (0.3% w/v) of ketorolac {Generic Name: TORADOL} (Nonsteroidal Anti-inflammatory) - via intracameral delivery
Ketorolac Tromethamine {TORADOL} (0.5%) - Topical EyedropOther
Topical ketorolac tromethamine {TORADOL, Nonsteroidal Anti-inflammatory} (0.5%) administered 4 times daily for the 3 days leading up to surgery. The last drop is to be given at least 2 hours prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| OMIDRIA | Active comparator | OMIDRIA is a combination product containing 10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac in a single-patient-use vial. Once the 4mL of OMIDRIA is diluted in 500 mL of ophthalmic irrigation solution, the resulting solution is intended to be used as needed during cataract surgery or intraocular lens replacement. Receives: Combination Product: OMIDRIA (*Registered Product) {10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac} |
| Topical Ketorolac | Active comparator | Topical ketorolac tromethamine 0.5% is a nonsteroidal anti-inflammatory drug. It is FDA-approved for the treatment of inflammation following cataract surgery and relief of ocular itching due to seasonal allergic conjunctivitis. Receives: Other: Ketorolac Tromethamine {TORADOL} (0.5%) - Topical Eyedrop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of ketorolac in the vitreous humor
Vitreous samples taken from vitrectomy at the beginning of the procedure for all patients.
Measured: The day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Sep 2023
- Primary completionNov 2025 (estimated)
- Study completionFeb 2026 (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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DHS Consulting
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Donnenfeld, MD, Principal investigator, Ophthalmic Consultants of Long Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539637
- Sponsor's protocol ID
- 00068701
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Donnenfeld ED, Narain S, Shoshany T, Perry HD, Connell SB. Aqueous and Vitreous Ketorolac Levels in Combined Cataract and Pars Plana Vitrectomy with Intracameral Ketorolac 0.3% Versus Topical Ketorolac 0.4. Ophthalmol Ther. 2026 Oct 22. doi: 10.1007/s40123-026-01525-8. Online ahead of print.
PubMed 42911532
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketorolac Levels in Vitreous and Aqueous Samples From Patients Undergoing Combined Cataract and Pars Plana Vitrectomy Surgeries With and Without Intracameral Phenylephrine 1.0% / Ketorolac 0.3%
- ClinicalTrials.gov ID
- NCT06539637
- Acronym / sponsor ID
- 00068701
- Conditions
- Cataract
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- DHS ConsultingUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 6 Aug 2024 (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 clinical trial evaluating Ketorolac levels in vitreous and aqueous humor samples from patients undergoing combined cataract and pars plana vitrectomy surgeries with and without intracameral phenylephrine 1.0% / ketorolac 0.3% (OMIDRIA). Patients not receiving intracameral OMIDRIA will receive topical ketorolac prior to cataract surgery/pars plana vitrectomy.
Detailed description
Cataract surgery can result in intra- and postoperative inflammation. Various strategies are employed to prevent and combat this inflammatory reaction, including preoperative topical NSAIDs, intraoperative NSAIDs or steroids, and postoperative topical NSAIDs and/or steroids. The only FDA-approved NSAID for intraoperative use is the ketorolac component of OMIDRIA® (Rayner Surgical, Bellevue, WA, USA).
Animal studies have assessed the concentration of ketorolac in the vitreous and demonstrated therapeutic levels out to 10 hours postoperatively. There is no human data for ketorolac levels in the vitreous following intracameral administration of OMIDRIA at the time of cataract surgery.
This study will enroll approximately 10-20 patients undergoing combined cataract surgery immediately followed by pars plana vitrectomy. Aqueous and vitreous samples will be taken intraoperatively and sent to an independent lab for analysis of ketorolac concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMIDRIA | Active comparator | Combination Product: OMIDRIA (*Registered Product) {10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac}OMIDRIA is a combination product containing 10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac in a single-patient-use vial. Once the 4mL of OMIDRIA is diluted in 500 mL of ophthalmic irrigation solution, the resulting solution is intended to be used as needed during cataract surgery or intraocular lens replacement. |
| Topical Ketorolac | Active comparator | Other: Ketorolac Tromethamine {TORADOL} (0.5%) - Topical EyedropTopical ketorolac tromethamine 0.5% is a nonsteroidal anti-inflammatory drug. It is FDA-approved for the treatment of inflammation following cataract surgery and relief of ocular itching due to seasonal allergic conjunctivitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to provide informed consent
- Undergoing cataract surgery immediately followed by pars plana vitrectomy
- Diagnosed preoperatively with a structural pathology requiring vitrectomy (e.g., epiretinal membrane, macular hole, and symptomatic vitreous floaters)
- Willing and able to comply with all study procedures
- Male or female, aged ≥ 18 years
Key exclusion criteria (6 listed)
- Age < 18
- Participating in another clinical trial
- Patients undergoing cataract surgery or pars plana vitrectomy alone (not a combined procedure)
- Previous vitrectomy
- Complications at the time of cataract surgery
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 |
|---|---|---|
| OMIDRIA (*Registered Product) {10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac}10.16 mg/mL (1% w/v) of phenylephrine {Generic Name: Biorphen} (Adrenergic Receptor Agonist) and 2.88 mg/mL (0.3% w/v) of ketorolac {Generic Name: TORADOL} (Nonsteroidal Anti-inflammatory) - via intracameral delivery | Combination product | OMIDRIA |
| Ketorolac Tromethamine {TORADOL} (0.5%) - Topical EyedropTopical ketorolac tromethamine {TORADOL, Nonsteroidal Anti-inflammatory} (0.5%) administered 4 times daily for the 3 days leading up to surgery. The last drop is to be given at least 2 hours prior to surgery. | Other | Topical Ketorolac |
Primary outcome
Concentration of ketorolac in the vitreous humor
Time frame: The day of surgery
Vitreous samples taken from vitrectomy at the beginning of the procedure for all patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 42911532Donnenfeld ED, Narain S, Shoshany T, Perry HD, Connell SB. Aqueous and Vitreous Ketorolac Levels in Combined Cataract and Pars Plana Vitrectomy with Intracameral Ketorolac 0.3% Versus Topical Ketorolac 0.4. Ophthalmol Ther. 2026 Oct 22. doi: 10.1007/s40123-026-01525-8. Online ahead of print.
- 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.
Eric Donnenfeld, MD principal investigator
Ophthalmic Consultants of Long Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing OMIDRIA (*Registered Product) {10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac} and Ketorolac Tromethamine {TORADOL} (0.5%) - Topical Eyedrop in people with Cataract, run by DHS Consulting at 1 site in United States.
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 5 inclusion and 6 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 6 Aug 2024. 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 United States. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Eric Donnenfeld, MD (516 804 5200, ericdonnenfeld@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of ketorolac in the vitreous humor (time frame: The day of surgery). 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 NCT06539637, 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 6 Aug 2024.