Trial reportThe British journal of ophthalmology2016
Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery.
Trial report in The British journal of ophthalmology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02101359 (Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery Versus Reference Group), which is not on this map. Cited by 23 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery Versus Reference Group (Topical Mydriatics and Anaesthetic)
Who cites it
23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 61 citations in OpenAlex.
- Pharmacologic interventions for mydriasis in cataract surgery.The Cochrane database of systematic reviews · 2021Pooled it
- Topical anaesthesia plus intracameral lidocaine versus topical anaesthesia alone for phacoemulsification cataract surgery in adults.The Cochrane database of systematic reviews · 2020Pooled it
- Safety of an Intracameral Fixed Combination for Mydriasis and Intraocular Anaesthesia During Cataract Surgery.Clinical ophthalmology (Auckland, N.Z.) · 2024Trial
- Safety and efficacy of a standardized intracameral combination of mydriatics and anesthetic for cataract surgery in type-2 diabetic patients.BMC ophthalmology · 2020Trial
- Tropicamide/Phenylephrine/Lidocaine Intracameral Injection: A Review in Cataract Surgery.Clinical drug investigation · 2019Trial
- Trial
- Intracameral medications in cataract surgery.International ophthalmology · 2025Review
- Mydriasis Stability During Cataract Surgery in Patients with Systemic Comorbidities Using a Standardised Combination of Intracameral Mydriatics and Anaesthetic.Life (Basel, Switzerland) · 2025Article
- Effectiveness of a Standardized Combination of Intracameral Mydriatics and Anaesthetic on Mydriasis during Cataract Surgery with Coexisting Diseases.Life (Basel, Switzerland) · 2023Article
- Nanotechnology-based ocular drug delivery systems: recent advances and future prospects.Journal of nanobiotechnology · 2023Review
- Efficacy and safety of intraoperative use of tropicamide 0.02%/phenylephrine0.31%/lidocaine1% intracameral combination during pediatric cataract surgery.International ophthalmology · 2023Observational
- Pupil diameter during cataract surgery after intracameral injection of the first ready-to-use combination of mydriatics and anaesthetic at the beginning of surgery in patients with a preoperative pupil diameter <6 mm.Acta ophthalmologica · 2023Article
- Commentary: Intracameral mydriatics in cataract surgery.Indian journal of ophthalmology · 2022Article
- Iatrogenic Dry Eye Disease: Dealing with the Conundrum of Post-Cataract Discomfort. A P.I.C.A.S.S.O. Board Narrative Review.Ophthalmology and therapy · 2021Review
- Article
- Protecting the Ocular Surface at the Time of Cataract Surgery: Intracameral Mydriatic and Anaesthetic Combination Versus A Standard Topical Protocol.Ophthalmology and therapy · 2020Article
- Stable Mydriasis After Intracameral Injection of a Combination of Mydriatics and Anesthetic During Cataract Surgery: A Real-Life, Multicenter Study.Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics · 2020Observational
- In Situ Gelling Ophthalmic Drug Delivery System for the Optimization of Diagnostic and Preoperative Mydriasis: In Vitro Drug Release, Cytotoxicity and Mydriasis Pharmacodynamics.Pharmaceutics · 2020Article
- Pain Following the Use of Anesthesia Formulation Among Individuals Undergoing Cataract Surgery: A Randomized Controlled Trial.Frontiers in pharmacology · 2020Article
- Systemic exposure to intracameral vs topical mydriatic agents: in cataract surgery.Clinical ophthalmology (Auckland, N.Z.) · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 11 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
aimsTo compare the efficacy and safety of intracameral (IC) administration at the beginning of cataract surgery, of Mydrane, a standardised ophthalmic combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%, to a standard topical regimen.
methodsIn this international phase III, prospective, randomised study, the selected eye of 555 patients undergoing phacoemulsification with intraocular lens (IOL) implantation received 200 μL of Mydrane (Mydrane group) just after the first incision or a topical regimen of one drop each of tropicamide 0.5% and phenylephrine 10% repeated three times (reference group). The primary efficacy variable was achievement of capsulorhexis without additional mydriatics. The non-inferiority of Mydrane to the topical regimen was tested. The main outcome measures were pupil size, patient perception of ocular discomfort and safety.
resultsCapsulorhexis without additional mydriatics was performed in 98.9% of patients and 94.7% in the Mydrane and reference groups, respectively. Both groups achieved adequate mydriasis (>7 mm) during capsulorhexis, phacoemulsification and IOL insertion. IOL insertion was classified as 'routine' in a statistically greater number of eyes in the Mydrane group compared with the reference group (p=0.047). Patients in the Mydrane group reported statistically greater comfort than the reference group before IOL insertion (p=0.034). Safety data were similar between groups.
conclusionsMydrane is an effective and safe alternative to standard eye drops for initiating and maintaining intraoperative mydriasis and analgesia. Patients who received IC Mydrane were significantly more comfortable before IOL insertion than the reference group. Surgeons found IOL insertion less technically challenging with IC Mydrane. TRIAL REGISTRATION NUMBER: NCT02101359; Results.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.