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Internal Limiting Membrane Flap in the Management of Retinal Detachment Due to Paracentral Retinal Breaks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03707015
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
San Ni Chen, Changhua Christian Hospital

Brief Summary:
To describe the technique and outcomes of using either inverted or free internal limiting membrane flap in the management of retinal detachment due to paracentral retinal breaks.

Condition or disease
Retinal Detachment Surgery

Detailed Description:
This retrospective observational case series includes nine patients received surgery for retinal detachment due to paracentral retinal breaks developed either from primary rhegmatogenous orgin, or secondary iatrogenic retinal breaks after prior membrane peeling or during surgery for tractional retinal detachment. Either inverted or free internal limiting membrane flaps were inserted in the identified breaks, followed by air fluid exchange and gas tamponade. Visual acuity and structural changes were evaluated.

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Internal Limiting Membrane Flap in the Management of Retinal Detachment Due to Paracentral Retinal Breaks
Actual Study Start Date : January 2017
Actual Primary Completion Date : June 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. re-attachment rate of retinal detachment [ Time Frame: within 3 months postoperatively ]
    re-attachment of retina through examination including fundoscopic exam and optical coherent tomography exam


Secondary Outcome Measures :
  1. visual acuity [ Time Frame: within 3 months postoperatively ]
    visual acuity in logMAR



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
We included patients with retinal detachment and posterior paracentral retinal breaks located within the equator from January 2017 to January 2018. Eyes with macular hole were excluded. All of the cases underwent standard pars plana vitrectomy using the ILM flap technique, accompanied by extended gas tamponade without laser retinopexy
Criteria

Inclusion Criteria:

  • Patients with retinal detachment and posterior paracentral retinal breaks located within the equator from January 2017 to January 2018

Exclusion Criteria:

  • Patient with macular hole
  • Patient with other ocular diseases including ocular hypertension, optic nerve atrophy, glaucoma or chronic uveitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707015


Sponsors and Collaborators
San Ni Chen
Investigators
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Principal Investigator: San-Ni Chen, M.D Changhua Christian Hospital
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: San Ni Chen, Department of Ophthalmology, Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT03707015    
Other Study ID Numbers: 180315
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by San Ni Chen, Changhua Christian Hospital:
Retinal Detachment; internal limiting membrane flap; retinal paracentral breaks
Additional relevant MeSH terms:
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Retinal Detachment
Retinal Perforations
Dissociative Disorders
Mental Disorders
Retinal Diseases
Eye Diseases