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

Completed

• Conditions: Retinal Detachment
• Interventions: Procedure: chandelier-assisted peripheral vitrectomy under air

• Registration Number: NCT03218371
• Lead Sponsor: Dar El Oyoun Hospital

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.

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 Timeline

• Study Start: 2013-10
• Primary Completion: 2016-01
• Study Completion: 2017-04
• Status Verified: 2017-07
• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-12
• Last Update Submitted: 2017-07-12
• Study First Posted: 2017-07-14
• Last Update Posted: 2017-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group (Indentation)	chandelier-assisted peripheral vitrectomy under air	Eyes (participants) for whom chandelier-assisted peripheral vitrectomy under air had been performed with scleral indentation. (Exposure)
control group (Non-indentation)	chandelier-assisted peripheral vitrectomy under air	eyes (participants) for whom chandelier-assisted peripheral vitrectomy under air had been performed without scleral indentation.

Primary Outcome Measures

Name	Time	Method
Trimming-induced retinal breaks (TIRB) (yes/ No)	intraoperative	number of eyes with iatrogenic retinal breaks along vitreous base during vitreous base trimming

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dareloyoun hospital; 🇪🇬 Cairo, Egypt