Early Vs Late Post Traumatic Cataract Surgery
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|ClinicalTrials.gov Identifier: NCT02900365|
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : September 14, 2016
Farabi Eye Hospital
Information provided by (Responsible Party):
mohammad soleimani, Farabi Eye Hospital
In a randomized clinical trial, 30 eyes with traumatic cataract after open globe injury with IOL implantation underwent early and 30 eyes underwent late cataract surgery. We excluded patients who were under 12-year-old. All patients were visited at 1week, 4 weeks , 12 weeks and six months after surgery. In each visit, patients were examined regarding visual acuity, intraocular pressure (IOP), anterior chamber inflammation, IOL position and posterior synechiae. In addition, posterior segment evaluation and funduscopy were performed. Intraoperative complication including posterior capsular rupture, anterior vitrectomy and zonulysis as well as the site of IOL implantation were documented and postoperative complications including raised IOP, anterior chamber inflammation, visual axis opacity, posterior synechiae, subluxation of IOL, IOL pigment deposition were listed.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Cataract||Procedure: early cataract surgery & IOL implantation Procedure: late cataract surgery & IOL implantation||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Early Vs Late Post Traumatic Cataract Surgery and Intraocular Lens Implantation|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Experimental: Early cataract surgery group
Eyes which presented with cataract and underwent surgery within 1 week were included in the early procedure group. They underwent "early cataract surgery & IOL implantation"
Procedure: early cataract surgery & IOL implantation
first week cataract extraction and IOL implantation.
Experimental: Late cataract surgery group
Eyes which presented with cataract and underwent surgery at least 1 month after trauma were included in the secondary procedure group.They underwent "Late cataract surgery & IOL implantation".
Procedure: late cataract surgery & IOL implantation
first month cataract extraction and IOL implantation.
Primary Outcome Measures :
- BCVA [ Time Frame: 6 months ]best corrected visual acuity
Secondary Outcome Measures :
- Posterior capsular rupture [ Time Frame: during operation ]Posterior capsular rupture during operation
- inflammation [ Time Frame: 6 month ]Anterior chamber inflammation assessed by Standardization of Uveitis Nomenclature (SUN) Working Group grading scheme for anterior chamber cells and flare and grade ≥2+ was considered significant
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