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

Retinal Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03218371
• Other study ID #: DEO00001258
• Status: Completed
• Phase: N/A
• First received: July 7, 2017
• Last updated: July 12, 2017
• Start date: October 2013
• Est. completion date: April 2017

Study information

• Verified date: July 2017
• Source: Dar El Oyoun Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment

Intervention

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

Locations

Country	Name	City	State
Egypt	Dareloyoun hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Dar El Oyoun Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

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