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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
Sponsor:
Information provided by (Responsible Party):
mohammad soleimani, Farabi Eye Hospital

Brief Summary:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
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 :
  1. BCVA [ Time Frame: 6 months ]
    best corrected visual acuity


Secondary Outcome Measures :
  1. Posterior capsular rupture [ Time Frame: during operation ]
    Posterior capsular rupture during operation

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eyes which presented with cataract and underwent surgery within 1 week were included in the early procedure group.
  • Eyes which presented with cataract and underwent surgery at least 1 month after trauma were included in the secondary procedure group.

Exclusion Criteria:

  • Eyes that primary repair and cataract extraction were done at the same time excluded from the study (because these eyes had anterior capsular rupture and disseminated lens material in the anterior chamber necessitating early surgery).
  • Also cases that IOL implantation was not possible at the time of cataract extraction were excluded.

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Responsible Party: mohammad soleimani, Assistant Professor, Farabi Eye Hospital
ClinicalTrials.gov Identifier: NCT02900365     History of Changes
Other Study ID Numbers: 17865
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by mohammad soleimani, Farabi Eye Hospital:
trauma
cataract
lensectomy
time
early
late
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases