Early Vs Late Post Traumatic Cataract Surgery

NCT02900365 | Completed DMC

• 1 other identifier: 17865
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Traumatic Cataract

Keywords

trauma; cataract; lensectomy; time; early; late

Outcome Measures

Primary Outcomes (1)

• BCVA

  best corrected visual acuity

  6 months

Secondary Outcomes (2)

• Posterior capsular rupture

  during operation

• inflammation

  6 month

Study Arms (2)

Early cataract surgery group

EXPERIMENTAL

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

Late cataract surgery group

EXPERIMENTAL

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

Interventions

early cataract surgery & IOL implantation PROCEDURE

first week cataract extraction and IOL implantation.

Early cataract surgery group

late cataract surgery & IOL implantation PROCEDURE

first month cataract extraction and IOL implantation.

Late cataract surgery group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Farabi Eye Hospital: lead

MeSH Terms

Conditions

Wounds and Injuries; Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2016
• First Posted: September 14, 2016
• Study Start: March 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share