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Completed

NCT Number: NCT03218371

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

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.

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Key information

Conditions

Retinal Detachment Eye Diseases Retinal Diseases

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dareloyoun hospital

Cairo, 12611, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

chandelier-assisted peripheral vitrectomy under air

Procedure

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

Primary outcomes

  1. Trimming-induced retinal breaks (TIRB) (yes/ No)

    Time frame: intraoperative

    number of eyes with iatrogenic retinal breaks along vitreous base during vitreous base trimming

Secondary outcomes

  1. number of Trimming-induced retinal breaks (TIRB)

    Time frame: intraoperative

    number of iatrogenic retinal breaks along vitreous base during vitreous base trimming

  2. retinal redetachment rate (yes/no)

    Time frame: within 3 months

    number of eyes in which recurrent retinal detachment occurred

  3. final LogMAR BCVA

    Time frame: final follow-up visit ( at least 3 months)

    best spectacle corrected visual acuity measured by decimal charts then converted to LogMAR

  4. snellen BCVA > 20/100 (yes/ no)

    Time frame: 3 months

    number of eyes with best corrected visual acuity better than snellen's 20/100 measured by snellen's chart

  5. Chandelier shift (yes/no)

    Time frame: intraoperative

    the need to shift position of chandelier light

  6. Local anaesthesia augmentation (yes/no)

    Time frame: intraoperative

    the need for augmenting local anesthesia for the participant to tolerate indentation

Sponsors and collaborators

Lead sponsor

Dar El Oyoun Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jul 14, 2017
Registry last updated
Jul 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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