Outcomes of Vitrectomy in Pediatric Retinal Detachment With Proliferative Vitreoretinopathy

Pediatric Rhegmatogenous Retinal Detachment Clinical Trial

Official title:

Outcomes of Vitrectomy in Pediatric Retinal Detachment With Proliferative Vitreoretinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03208205
• Other study ID #: 0001
• Status: Completed
• Phase: N/A
• First received: June 1, 2017
• Last updated: July 2, 2017
• Start date: January 1, 2006
• Est. completion date: January 1, 2017

Study information

• Verified date: July 2017
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Dissociative Disorders
• Pediatric Rhegmatogenous Retinal Detachment
• Retinal Detachment

Intervention

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.

Locations

Country	Name	City	State
Poland	General Department of Ophthalmology in Lublin	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistent retinal reattachment	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	30 months