Combined Pre-operative Treatment for Cataracts
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Inder Paul Singh, M.D.
No Placebo Group
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This is a multicenter, 2-arm, randomized, prospective study of patients slated for bilateral cataract extraction. One eye will be randomized to the Study Arm, and the fellow eye will be randomized to the Control Arm.
Is triamcinolone acetonide generally safe for humans?
Triamcinolone acetonide has been used in many patients for conditions like asthma and nasal issues, with most experiencing no serious side effects. However, some people have reported side effects like weight gain, menstrual changes, high blood pressure, and swelling.
12345Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those taking oral anti-inflammatory medications for systemic diseases, except for low-dose aspirin and ibuprofen for headaches.
Eligibility Criteria
This trial is for patients scheduled for cataract surgery in both eyes. It's not clear what the specific inclusion or exclusion criteria are, but typically participants would need to be adults with a diagnosis of cataracts and no other major eye diseases.Inclusion Criteria
I am over 18 and scheduled for cataract surgery in both eyes.
Exclusion Criteria
I have glaucoma or react strongly to steroids.
I have had cataract surgery with another procedure.
I have not had an eye injection in the last 6 months.
Participant Groups
The study compares complication rates between two treatments during cataract surgery. One eye gets NSAID, OMIDRIA, and triamcinolone (Study Arm), while the other eye receives standard care (Control Arm). The assignment of each treatment to an eye is random.
2Treatment groups
Experimental Treatment
Active Control
Group I: Study Arm (OMIDRIA)Experimental Treatment1 Intervention
* Pre-op, 1 drop ketorolac (0.5%) {Toradol}, 1 drop moxifloxacin (0.5%) {Avelox}
* Prior to surgery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%)
* Concl. of surgery while still in the OR: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) {Pred Forte}
* Post-op recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%).
Intraoperative interventions: intracameral phenylephrine {Sudafed} 1.0%/ketorolac 0.3%, {OMIDRIA} intracameral moxifloxacin (0.5%), and subconjunctival triamcinolone acetonide (0.4 mL, 10 mg/mL) {Kenalog}.
In-office drops administered by study staff at the end of the 1-day visit: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%).
Rescue therapy will be allowed, if necessary, at the discretion of the evaluating physician and will consist of prednisolone acetate (1%) QID (taper also at the discretion of the evaluating physician).
Group II: Control Arm (Standard of Care)Active Control1 Intervention
Self-administration of:
Ketorolac (0.5%) {Toradol} four times daily (QID) x 1 day and moxifloxacin (0.5%) {Avelox} drops three times daily (TID) x 1 day before SX.
On the Day of SX, eyes will receive in-office drops administered by study staff according to the following:
* In pre-operative holding: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%)
* Immediately prior to SX: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%)
* At the conclusion of SX while still in the operating room: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) Pred Forte}
* Any time in post-op recovery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%).
Eyes will then self-administer the following postoperative interventions: ketorolac drops QID x 1 month. Prednisolone acetate tapering QID x1 week, TID x 1 week, twice daily (BID) x 1 week, and once daily (QD) x 1 week; and moxifloxacin drops TID x 1 week.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
The Eye Associates - VeniceVenice, FL
The Eye Centers of Racine & KenoshaRacine, WI
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Who is running the clinical trial?
Inder Paul Singh, M.D.Lead Sponsor
The Eye AssociatesCollaborator
References
Corticosteroid injections of the nasal turbinates: past experience and precautions. [2019]Clinical experience with triamcinolone acetonide (Kenalog) injections into the nasal turbinates for allergic and vasomotor rhinitis is reported by two authors. Gratifying results have occurred in most of the over 60,000 patients treated, with no serious side effects. Two cases of intravascular injections of another corticosteroid reaching the retinal circulation are reported, and methods for preventing this complication are proposed.
The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. [2013]A group of 145 patients with severe intrinsic bronchial asthma symptoms was treated with repeated intramuscular injections of triamcinolone acetonide (Kenalog) during an average period of two years. Kenalog was administered mainly to persons with persistent attacks of asthmatic dyspnea and frequent recurrent infections of the respiratory tract in which other drugs, including orally administered steroids, did not lead to any improvement in the asthmatic symptoms. The results of therapy were excellent (total disappearance of asthmatic manifestations) or good (considerable improvement of asthma symptoms) in 88.3% of treated cases, while in 11.7% of patients, Kenalog had no effect. In 13.8% of cases, side effects, especially weight gain, disturbances in menstruation, increase in blood pressure, edema and spontaneous echymoses were observed. The triamcinolone acetonide depot-preparation is, in the authors' opinion, highly effective in the management of severe intrinsic asthma cases, unsucessfully treated by other methods. The prolonged use of Kenalog can, however, like other steroids provoke, several side effects.
Isolating triamcinolone acetonide particles for intravitreal use with a porous membrane filter. [2019]To report a new, simple, rapid method to isolate triamcinolone acetonide particles and to remove additives from its commercially available suspension (Kenacort-A) for intravitreal use.
Toxicity of triamcinolone acetonide on retinal neurosensory and pigment epithelial cells. [2013]To study the toxicity of triamcinolone acetonide (Kenalog; Bristol-Meyers Squibb, Princeton, NJ) on retinal pigment epithelial (ARPE-19) and retinal neurosensory (R28) cells.
[Safety and efficacy of subconjunctival triamcinolone injections in the management of uveitic macular edema: retrospective study of thirty-one cases]. [2014]Triamcinolone acetonide (Kenacort) is a corticosteroid that can be administrated by subconjunctival injection, with an extended release for up to three months. Our retrospective study aims to analyze safety and efficacy of subconjunctival triamcinolone injections in the treatment of uveitic macular edema. We included 31 eyes of 30 patients, who had one or several injections. We studied the progression of visual acuity, central macular thickness by optical coherence tomography (OCT), intraocular pressure, and presence or absence of cataract, on the day of injection (T0), and at 1, 3, 6 and 12 months after injection. Twenty-one patients had only one injection; 10 patients had 2. The 12-month follow-up showed an improvement in visual acuity with an initial mean of 0.36 ± 0.27 logMAR to 0.23 ± 0.33 logMAR at 3 months of follow-up (P