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

Scleral Self-indentation During Chandelier-assisted Peripheral Vitrectomy Under Air for Rhegmatogenous Retinal Detachment: A Retrospective Cohort Study.

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.

Study Overview

• Status: Completed
• Conditions: Retinal Detachment
• Intervention / Treatment: Procedure: chandelier-assisted peripheral vitrectomy under air

Detailed Description

Retrospective cohort study. One hundred and thirty eyes of 130 participants with primary rhegmatogenous retinal detachment were identified. All the participants had undergone a chandelier-assisted peripheral vitrectomy under air. Scleral self-indentation had been used in 68 eyes (study group) (Indentation group), while non-indentation had been used in 62 eyes (comparison group) (Non-indentation group). Outcome variables included: Trimming-induced retinal breaks (TIRB), retinal redetachment rate, final LogMAR BCVA, and intraoperative complications.

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12611
    • Dareloyoun hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; chandelier-assisted peripheral vitrectomy under air for management of peripheral vitreous during RD vitrectomy; whether using indentation or non-indentation
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; chandelier-assisted peripheral vitrectomy under air for management of peripheral vitreous during RD vitrectomy; whether using indentation or non-indentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trimming-induced retinal breaks (TIRB) (yes/ No)	number of eyes with iatrogenic retinal breaks along vitreous base during vitreous base trimming	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of Trimming-induced retinal breaks (TIRB)	number of iatrogenic retinal breaks along vitreous base during vitreous base trimming	intraoperative
retinal redetachment rate (yes/no)	number of eyes in which recurrent retinal detachment occurred	within 3 months
final LogMAR BCVA	best spectacle corrected visual acuity measured by decimal charts then converted to LogMAR	final follow-up visit ( at least 3 months)
snellen BCVA > 20/100 (yes/ no)	number of eyes with best corrected visual acuity better than snellen's 20/100 measured by snellen's chart	3 months
Chandelier shift (yes/no)	the need to shift position of chandelier light	intraoperative
Local anaesthesia augmentation (yes/no)	the need for augmenting local anesthesia for the participant to tolerate indentation	intraoperative

Collaborators and Investigators

• Sponsor: Dar El Oyoun Hospital
• Investigators: Principal Investigator: Wael A Ewais, MD, consultant vitreoretinal surgeon

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: scleral indentation; chandelier light; air vitrectomy; rhegmatogenous retinal detachment
• Additional Relevant MeSH Terms: Mental Disorders; Eye Diseases; Retinal Diseases; Retinal Detachment; Dissociative Disorders
• Other Study ID Numbers: DEO00001258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No