Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Outcomes of Vitrectomy in Pediatric Retinal Detachment With Proliferative Vitreoretinopathy

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: NCT03208205
Recruitment Status : Completed
First Posted : July 5, 2017
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Medical University of Lublin

Brief Summary:

The aim of this study is to report outcomes of pars plana vitrectomy (PPV) in pediatric retinal detachment (RD) accompanied with proliferative vitreoretinopathy (PVR) as well as complications and factors influencing the final anatomical and functional results.

This is retrospective consecutive case series of 14 eyes treated with primary PPV for RD repair. Average postoperative follow-up period is 34 months.


Condition or disease Intervention/treatment
Pediatric Rhegmatogenous Retinal Detachment Procedure: vitrectomy

Detailed Description:

This is the retrospective study of 14 consecutive patients younger than 18 years age who underwent primary PPV at the Department of General Ophthalmology of Medical University of Lublin in a time period from 1st January 2006 to 1st January 2017. This study followed the tenets of the Declaration of Helsinki. The treatment chosen in the study was a part of a standard care. Written informed consent was taken from all subjects. All patients underwent vitreoretinal surgery due to RD (rhegmatogenous, tractional or combined rhegmatogenous and tractional). Exclusion criteria from the study was the time of follow-up less than 6 months.

Average age at the time of the presence of RD was 10±4.7 years (range 4-17 years). Pre- and postoperative data were collected. Descriptive statistical analysis included gender, age at the presentation, laterality, etiology, duration of presenting symptoms, presences of ocular comorbidities, macular status (attached or non-attached), presence of PVR grade C, initial and final best-corrected visual acuity (BCVA), number of procedures, type of endotamponade during PPV, final lens status, duration of the follow-up, anatomical success and complications. Indications for PPV were as follows: presence of advanced PVR and/or total RD and/or multiple breaks, giant retinal tears. PVR was graded according to the Retina Society Terminology Classification [9]. Visual acuity was measured by Snellen charts. The anatomical success was defined as persistent retinal reattachment at the last follow-up visit (regardless of presence or absence of silicone oil tamponade).

Statistical computations were performed using STATISTICA 13PL (Stasoft, USA) programme.


Layout table for study information
Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Outcomes of Vitrectomy in Pediatric Retinal Detachment With Proliferative Vitreoretinopathy
Actual Study Start Date : January 1, 2006
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: vitrectomy
    Complete 23G PPV with scleral indentation was performed using Constellation system. Posterior vitreous detachment was induced very carefully by the cutter probe using aspiration. The peripheral vitreous was removed in all eyes with 360° of the vitreous base shaved under scleral indentation. After complete retinal attachment was achieved, endolaser photocoagulation was applied around the retinal break(s) as three to four rows of burns or/and cryopexy under HPFCL. Then a HPFCL/air/5000cst silicone oil exchange was performed. In one eye only HPFCL/air exchange was performed. Sclerotomies were sutured when needed with Vicryl 8.0 sutures.


Primary Outcome Measures :
  1. Persistent retinal reattachment [ Time Frame: 30 months ]

    Pre- and postoperative data were collected. Descriptive statistical analysis included gender, age at the presentation, laterality, etiology, duration of presenting symptoms, presences of ocular comorbidities, macular status (attached or non-attached), presence of PVR grade C, initial and final best-corrected visual acuity (BCVA), number of procedures, type of endotamponade during PPV, final lens status, duration of the follow-up, anatomical success and complications. Indications for PPV were as follows: presence of advanced PVR and/or total RD and/or multiple breaks, giant retinal tears. PVR was graded according to the Retina Society Terminology Classification [9]. Visual acuity was measured by Snellen charts. The anatomical success was defined as persistent retinal reattachment at the last follow-up visit (regardless of presence or absence of silicone oil tamponade).

    Statistical computations were performed using STATISTICA 13PL (Stasoft, USA) programme




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

Inclusion Criteria:

  • patients younger than 18 years age who underwent primary PPV at the Department of General Ophthalmology of Medical University of Lublin in a time period from 1st January 2006 to 1st January 2017

Exclusion Criteria:

  • age up to 18 years old

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): NCT03208205


Locations
Layout table for location information
Poland
General Department of Ophthalmology in Lublin
Lublin, Poland, 20-001
Sponsors and Collaborators
Medical University of Lublin

Layout table for additonal information
Responsible Party: Medical University of Lublin
ClinicalTrials.gov Identifier: NCT03208205     History of Changes
Other Study ID Numbers: 0001
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Dissociative Disorders
Retinal Detachment
Vitreoretinopathy, Proliferative
Mental Disorders
Retinal Diseases
Eye Diseases