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.

Sponsors

Lead Sponsor: Dar El Oyoun Hospital

Source 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.

Overall Status Completed
Start Date October 2013
Completion Date April 2017
Primary Completion Date January 2016
Study Type Observational
Primary Outcome
Measure Time Frame
Trimming-induced retinal breaks (TIRB) (yes/ No) intraoperative
Secondary Outcome
Measure Time Frame
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
Local anaesthesia augmentation (yes/no) intraoperative
Enrollment 130
Condition
Intervention

Intervention Type: Procedure

Intervention Name: chandelier-assisted peripheral vitrectomy under air

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

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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)

Gender: All

Minimum Age: 16 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Wael A Ewais, MD Principal Investigator consultant vitreoretinal surgeon
Location
Facility: Dareloyoun hospital
Location Countries

Egypt

Verification Date

July 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Dar El Oyoun Hospital

Investigator Full Name: Wael Ahmed Ewais

Investigator Title: MD, Lecturer in Department of Ophthalmology, Faculty of Medicine, Cairo University; and consultant vitreoretinal surgeon in Dar El Oyoun Hospital

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: study group (Indentation)

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

Label: control group (Non-indentation)

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

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov