Pain Expression in the Perioperative Period of Cataract Surgery

NCT01824927 — Not applicable, Unknown, 150 participants, Evidence Based Cataract Study Group

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT01824927
Status	Unknown
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: single, supportive care
Enrollment	150 (Estimated)
Sponsor	Evidence Based Cataract Study Group (Other)
Conditions	Cataract, Surgery, Eye Pain
Interventions	First eye (FE), Second eye (SE), Steroids eye drops (Procedure, drug)
Dates	start 2013-01-01, primary completion 2013-05-01 (estimated), first posted 2013-04-05, last updated 2013-04-05
Locations	1 site in China

-Summary

Patients having cataract extraction in the second eye under topical anesthesia with monitored anesthesia care often report increased pain and awareness relative to the first surgery in the fellow eye, despite similar operative and anesthetic conditions. The purpose of this study is to investigate the pathogenesis of this phenomenon.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
First eye (FE)	Active comparator	Procedure: First eye (FE); Drug: Steroids eye drops	Phacoemulsification cataract extraction surgery of first eye
Second eye (SE)	Active comparator	Procedure: Second eye (SE); Drug: Steroids eye drops	Phacoemulsification cataract extraction surgery of second eye
Steroids eye drops	Experimental	Procedure: First eye (FE); Procedure: Second eye (SE)	Dexamethasone eye drop, 1 drop, qid, for 3 days before surgery

First eye (FE) (Procedure): Phacoemulsification cataract extraction surgery
Second eye (SE) (Procedure): Phacoemulsification cataract extraction surgery
Steroids eye drops (Drug): Use steroids eye drops to decrease the pain.

+Outcome measures

Primary outcomes

Post operative pain level [3 days]: Post operative pain level recorded on a VAS (0-10) at rest for the first three days after cataract surgery.

+Eligibility

Sex: All, ages: 50 Years to 85 Years

Inclusion Criteria:

* Age-related cataract patients aged 50 years or older able to give informed consent undergoing cataract surgery;
* Pupil dilation ≧7 mm after mydrisis;
* VA prognosis ≧6/12

Exclusion Criteria:

* Unable to give informed consent;
* Patients with history of ocular pathology or diabetic retinopathy;
* Patients with traumatic, subluxated and posterior polar cataract;
* Patients had other ocular surgery (not cataract surgery) in the past 6 months;
* Patients with significant intra-operative complications

+Locations (1)

Facility	City	Country	Status
Eye and ENT Hospital of Fudan University	Shanghai, Shanghai Municipality	China	Recruiting

+Publications

Results publication: Zhu XJ, Wolff D, Zhang KK, He WW, Sun XH, Lu Y, Zhou P. Molecular Inflammation in the Contralateral Eye After Cataract Surgery in the First Eye. Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5566-73. doi: 10.1167/iovs.15-16531. PMID 26305528