Clinical Trials Logo
  1. Home
  2. Trauma
  3. NCT01509092
  4. Details
NCT01509092 Clinical Trial

Comparative Study Between Early Vitrectomy and Observation for Spontaneous Closure of Traumatic Macular Hole

Trauma Clinical Trial

Official title:
Traumatic Macular Hole: Six-months Observation Versus Early Surgical Intervention, A Multicenter Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01509092
Other study ID # PekingUTH-TMH-2011
Secondary ID
Status Completed
Phase N/A
First received December 28, 2011
Last updated October 6, 2014
Start date January 2012
Est. completion date June 2014

Study information
Verified date January 2012
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics CommitteeChina: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the anatomical and visual recovery of eyes with traumatic macular hole (TMH) following either early vitrectomy or 6-month observation.

Description:

Patients who received vitrectomy immediately after the injury were compared with patients who were observed for six months for spontaneously closure.The closure rate, foveal microstructure, and final visual acuity were analyzed.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date June 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- closed globe injury

- identification of full-thickness macular hole by optical coherence tomography within one month after trauma

Exclusion Criteria:

- open globe injury

- coexistence of idiopathic macular hole

- severe opaque in the visual axis caused by the injury(eg. severe cataract, severe vitreous hemorrhage)

- combined injuries requiring immediate surgical intervention (eg. lens dislocation, retinal detachment, cyclodialysis)

- coexistence of high myopia

- coexistence of choroidal rupture or subretinal hemorrhage within the diameter of 400µm from the center of the foveola

- coexistence of severe optic nerve injury (no light perception, positive afferent pupillary defect)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• vitrectomy surgery
"pars plana vitrectomy +internal limiting membrane peeling" done immediately after the identification of the macular hole

Locations
Country Name City State
China China - Japan Friendship Hospital Beijing
China Peking University Third Hospital Beijing
China Southwest Eye hospital of Third Military Medical University Chongqing
China The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang
China Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University school of Medicine Shanghai
China Weifang Eye Hospital Weifang Shandong
China Wenzhou Medical College Wenzhou Zhejiang
China Eye Hospital of Hebei Province Xingtai Hebei

Sponsors (1)
Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary macular hole closure rate 6 month after injury No
Secondary central foveal thickness 6 month after hole closure No
Secondary length of inner-segment outer-segment junction defect 6 month after hole closure No
Secondary final visual acuity 6 month after hole closure No
See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Terminated NCT03781817 - Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures Phase 4
Completed NCT04342416 - Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women N/A
Recruiting NCT04856449 - DBT Skills Plus EMDR for BPD and Trauma N/A
Completed NCT04356963 - Adjunct VR Pain Management in Acute Brain Injury N/A
Completed NCT05669313 - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Recruiting NCT04725721 - Testing FIRST in Youth Outpatient Psychotherapy N/A
Active, not recruiting NCT05530642 - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Not yet recruiting NCT03696563 - FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS N/A
Withdrawn NCT03249129 - Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
Completed NCT02240732 - Surgical Tourniquets and Cerebral Emboli N/A
Completed NCT02227979 - Effects of PURPLE Cry Intervention N/A
Withdrawn NCT01169025 - Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients N/A
Recruiting NCT01812941 - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients N/A
Completed NCT03112304 - Child STEPS for Youth Mental Health in Maine Sustainability N/A
Completed NCT01475344 - Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC) Phase 1/Phase 2
Completed NCT01201863 - Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy Phase 4
Completed NCT01210417 - Trauma Heart to Arm Time N/A