23-gauge Pars Plana Vitrectomy With Silicone Oil Injectionsilicone Oil Injection With Surgical

NCT04280770 | Completed DMC

• 1 other identifier: FWA000017585 FMASU 25/2017
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: to evaluate anatomical and visual outcomes of 23-gauge vitrectomy for retinal detachment with silicone oil injection in fifty cases. The rate of recurrence, the incidence of proliferative vitreoretinopathy (PVR) and the value of risk factors. Participants and Methods: fifty cases with RD with mixture of epiretinal and subretinal membranes were collected. Pars plan vitrectomy, 23gauge vitrectomy were done to these cases, then silicone oil removed 6 weeks after primary surgery. Main Outcome Measures: The anatomical success rate,the failure rate ,the rate of retinal breaks in both groups, and reproliferation rate.

Conditions

Retinal Detachment

Keywords

retina; silicone; laser; break; vitrectomy

Outcome Measures

Primary Outcomes (3)

• success rate

  success rate after first RD surgery and silicone oil removal

  42 days

• The failure rate

  The failure rate after silicone oil removal

  42 days

• number of surgical interference

  numbers of vitrectomies done after silicone oil removal

  4 years

Secondary Outcomes (1)

• lower retinal breaks

  4 years

Study Arms (2)

Non retinal detachment group

SHAM COMPARATOR

35 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks.

Procedure: 23 PARS PLANA VITRECTOMY

retinal detachment group

ACTIVE COMPARATOR

15 participants did 23 vitrectomy followed for 3-6 months. After that, we removed the oil and followed them for 6 weeks.

Procedure: 23 PARS PLANA VITRECTOMY

Interventions

23 PARS PLANA VITRECTOMY PROCEDURE

We performed a three-port vitrectomy: one infusion trocar and two instruments trocars. Non-contact wide-angle viewing systems (Resight- Biom) have a viewing field of 60-130° was used. Put 23 needle attached to the automated pump for silicone oil extraction. Strict examination of the retina to detect new breaks or untreated breaks. Closure of the sclerotomies.

Also known as: SILICONE OIL REMOVAL

Non retinal detachment group; retinal detachment group

Eligibility Criteria

• Age: 23 Years - 58 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• they had retinal detachment,
• moderate degrees of PVR
• PVR ≥ Grade C
• previous buckle surgery
• pseudophakia.

You may not qualify if:

• the retinal tear was greater than 90 degrees
• presence of intravitreal foreign body
• previous vitrectomy done before
• if follow-up data were unavailable for a minimum follow-up of 6 months following the final retinal procedure.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Each of the recruited patients were assigned a study number and randomized in accordance with a simple block randomization scheme.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Fifty participants were assigned and divided into two groups. Participants without RD after SO removal was recruited into group A-NRD, and participants with RD after SO removal was recruited into group B-RD.

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: January 30, 2009
• Primary Completion: March 11, 2013
• Study Completion: March 30, 2013
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share