Clinical trial NCT03218371: Scleral Self-indentation Chandelier-assisted Peripheral Vitrectomy Under Air Rhegmatogenous Retinal Detachment.
Official title: Scleral Self-indentation During Chandelier-assisted Peripheral Vitrectomy Under Air for Rhegmatogenous Retinal Detachment: A Retrospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Detachment
Keywords: scleral indentation
chandelier light
air vitrectomy
rhegmatogenous retinal detachment
Lead sponsor: Dar El Oyoun Hospital
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 130
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

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.

Eligibility 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)

Primary outcomes:
measure: Trimming-induced retinal breaks (TIRB) (yes/ No)
timeFrame: intraoperative
Secondary outcomes:
measure: number of Trimming-induced retinal breaks (TIRB)
timeFrame: intraoperative
measure: retinal redetachment rate (yes/no)
timeFrame: within 3 months
measure: final LogMAR BCVA
timeFrame: final follow-up visit ( at least 3 months)
measure: snellen BCVA > 20/100 (yes/ no)
timeFrame: 3 months
measure: Chandelier shift (yes/no)
timeFrame: intraoperative
measure: Local anaesthesia augmentation (yes/no)
timeFrame: intraoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dareloyoun hospital
Study officials:
affiliation: consultant vitreoretinal surgeon
name: Wael A Ewais, MD
role: PRINCIPAL_INVESTIGATOR
References: