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

NCT ID: NCT03218371

Last Updated: 2017-07-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-04-30

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.

Conditions

Retinal Detachment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

study group (Indentation)

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

chandelier-assisted peripheral vitrectomy under air

Intervention Type: PROCEDURE

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.

chandelier-assisted peripheral vitrectomy under air

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dar El Oyoun Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wael Ahmed Ewais

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wael A Ewais, MD

Role: PRINCIPAL_INVESTIGATOR

consultant vitreoretinal surgeon

Locations

Dareloyoun hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

DEO00001258

Identifier Type: -

Identifier Source: org_study_id