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Mydriasis clinical trials

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NCT ID: NCT01778959 Recruiting - Clinical trials for Management of Intraoperative Floppy-iris Syndrome and Small Pupils With Different Mechanical Devices

Methods to Manage Intra-operative Floppy-iris Syndrome and Poor Pupil Dilation in Cataract Surgery

IFIS
Start date: February 2012
Phase: N/A
Study type: Interventional

Cataract surgery is one of the most frequently performed surgeries worldwide and complications are rare. However, there are factors that increase the risk of complications, such as poor pupil dilation and intra-operative floppy iris syndrome (IFIS). Reasons for a small pupil size are pseudoexfoliation syndrome (PXF) syndrome, uveitis or synechia and the use of pilocarpin drops. IFIS is a syndrome usually caused by systemic alpha1-blockers (foremost tamsulosin) used to treat benign prostatic hyperplasia.1,2 As described by Chang and Campbell3 IFIS is characterized by billowing of a flaccid iris stroma, a propensity for iris prolapse towards the phacoemulsification tip as well as towards the incisions and progressive intra-operative pupil constriction. Stopping tamsulosin pre-operatively did not show to effectively prevent IFIS.4,5 However, it is of high importance to identify patients prior to surgery, who are treated with alpha1-blockers, or patients with a small pupil size and poor pharmacological pupil dilation. Some methods, such as intracameral injection of phenylephrine is only sufficient in a few cases 6, and a disadvantage is the risk of a hypertensive episode.7 Another pharmacological method is the use of atropine drops pre-operatively, but this method did not show to sufficiently reduce IFIS.4 Different methods were shown to reduce intra-operative problems due to IFIS/small pupil size: The use of highly cohesive ophthalmic viscosurgical devices (OVD), also called viscoadaptives, such as sodium hyaluronate (e.g. AMO Healon5 or Croma Eyefill H.D.) help to viscodilate the pupil and by resting on the iris during the entire phacoemulsification procedure reduce the risk of iris prolapsing towards the incisions. This method is more dependent on a central phacoemulsification technique and low fluidic parameters to allow the OVD to stay on the iris during the entire procedure.8 In case of a small pupil, pupil stretching with 2 instruments can be used additively. Another option to stabilize the pupil size is the use of mechanical pupil expansion devices, such as 1. Iris retractors - these devices are routinely used to dilate the pupil intra-operatively. Typically, 4 or 5 iris retractors, also called iris hooks, are inserted through 4-5 incisions. Usually, the IFIS pupil is very elastic and the risk of overstretching is small.8 2. Pupil expansion rings, such as the Malyugin ring. This ring is placed on the pupil margin with an injector through the main incision. It eliminates the need of additional incisions and saves time.9 Rationale To compare different methods to manage IFIS and poor pupil dilation in cataract surgery: a pupil expansion ring (Malyugin Ring), iris retractors (iris hooks) and a viscoadaptive OVD.

NCT ID: NCT01264653 Completed - Cataract Clinical Trials

Study of Intracameral Adrenaline for Pupil Dilation Without Topical Mydriatics in Refractive Cataract Surgery

Start date: December 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to study the safety and efficacy of intracameral adrenaline for pupil dilation without topical mydriatics in refractive cataract surgery.

NCT ID: NCT01170130 Completed - Cataract Clinical Trials

Lidocaine Usage for Pupil Dilatation (Mydriasis)

Start date: December 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if the mydriatic effect of intracameral lidocaine 1% is as effective as topical cyclopentolate 1% and phenylephrine 10% for achieving effective mydriasis during phacoemulsification surgery.

NCT ID: NCT01169688 Completed - Clinical trials for Pupil Dilation Prior to Cataract Surgery Out-patient

Preoperative Cataract Pupillary Dilation: Inpatient At The Ambulatory Surgery Center vs Outpatient Dilation Prior To Arrival At The Ambulatory Surgery Center

Start date: December 2007
Phase: N/A
Study type: Interventional

This study was done to compare efficacy, safety and efficiencies of various methods of pupil dilation prior to cataract surgery.

NCT ID: NCT00877175 Completed - Preterm Infants Clinical Trials

Comparison of Instillation and Packing in Mydriasis for Premature Infants

Start date: March 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the mydriatic effect of 2.5% phenylephrine and 1% tropicamide by conventional instillation and lower conjunctival fornix packing in premature infants.

NCT ID: NCT00690222 Terminated - Cataract Clinical Trials

Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

Start date: March 2008
Phase: N/A
Study type: Interventional

The purpose is to determine if an intracameral solution of 0.2% tropicamide and 2% phenylephrine can dilate the pupil for cataract surgery as well as pre-operative topical 1% tropicamide and 5% phenylephrine. We will be looking at two separate groups of patients, those with and those without pseudoexfoliation syndrome. We will be looking at how each method affects the size of the pupil at the beginning and at the end of cataract surgery. In addittion, we will look at what effect the two different methods have on blood pressure and heart rate in the pre-operative, peri-operative and post-operative periods.

NCT ID: NCT00501878 Completed - Diabetes Mellitus Clinical Trials

2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides

Start date: May 2007
Phase: Phase 4
Study type: Interventional

To compare the clinical efficacy and systemic side effects between 2.5% and 10% phenylephrine for mydriasis in diabetic patient with darkly pigmented irides.

NCT ID: NCT00120432 Completed - Eye Diseases Clinical Trials

Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation

Start date: December 2004
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy on pupillary dilation between the single dose versus the three doses of 1% tropicamide with 10% phenylephrine for complete ocular examination.