Scleral Self-indentation Chandelier-assisted Peripheral Vitrectomy Under Air Rhegmatogenous Retinal Detachment.

NCT03218371 | Completed

• 1 other identifier: DEO00001258
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators compared the incidence of trimming-induced retinal breaks, retinal redetachment rate, and final LogMAR BCVA; between scleral self-indentation and non-indentation during chandelier-assisted peripheral vitrectomy under air for eyes with primary retinal detachment. Self-indentation enables complete trimming of the vitreous base without causing iatrogenic retinal breaks, with a higher retinal reattachment rate, and with less need for chandelier shift than with non-indentation approach.

Conditions

Retinal Detachment

Keywords

scleral indentation; chandelier light; air vitrectomy; rhegmatogenous retinal detachment

Outcome Measures

Primary Outcomes (1)

• Trimming-induced retinal breaks (TIRB) (yes/ No)

  number of eyes with iatrogenic retinal breaks along vitreous base during vitreous base trimming

  intraoperative

Secondary Outcomes (6)

• number of Trimming-induced retinal breaks (TIRB)

  intraoperative

• retinal redetachment rate (yes/no)

  within 3 months

• final LogMAR BCVA

  final follow-up visit ( at least 3 months)

• snellen BCVA > 20/100 (yes/ no)

  3 months

• Chandelier shift (yes/no)

  intraoperative

Study Arms (2)

study group (Indentation)

Eyes (participants) for whom chandelier-assisted peripheral vitrectomy under air had been performed with scleral indentation. (Exposure)

Procedure: chandelier-assisted peripheral vitrectomy under air

control group (Non-indentation)

eyes (participants) for whom chandelier-assisted peripheral vitrectomy under air had been performed without scleral indentation.

Procedure: chandelier-assisted peripheral vitrectomy under air

Interventions

chandelier-assisted peripheral vitrectomy under air PROCEDURE

chandelier-assisted peripheral vitrectomy under air for management of peripheral vitreous during RD vitrectomy; whether using indentation or non-indentation

control group (Non-indentation); study group (Indentation)

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective cohort study that was done on eyes (participants) with rhegmatogenous retinal detachment (RRD) for whom chandelier-assisted peripheral vitrectomy under air (CPVA) had been performed; whether using scleral self-indentation (Exposure), or without scleral self-indentation (control)

You may qualify if:

• \- RRD with postoperative follow up \> 3 months, without PVR, or with PVR A-B

You may not qualify if:

• RRD with less than 3 months of postoperative follow-up,
• RRD with proliferative vitreoretinopathy grade C (PVR C),
• RRD with uveitis,
• RRD with choroidal detachment,
• Giant retinal tears,
• Retinal dialysis,
• Myopic macular hole RRD,
• Traumatic RD,
• Children \< 16 years old,
• The later vitrectomy (if vitrectomy had been performed for RRD in both eyes)

Sponsors & Collaborators

• Dar El Oyoun Hospital: lead

Study Sites (1)

Dareloyoun hospital

Cairo, 12611, Egypt

Location

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Wael A Ewais, MD

  consultant vitreoretinal surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Lecturer in Department of Ophthalmology, Faculty of Medicine, Cairo University; and consultant vitreoretinal surgeon in Dar El Oyoun Hospital

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 14, 2017
• Study Start: October 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: April 1, 2017
• Last Updated: July 14, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)