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Retinal Displacement After Pneumatic Versus Vitrectomy for Retinal Detachment (ALIGN)

NCT04089033 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 204

Last updated 2022-12-13

No results posted yet for this study

Summary

This is a prospective cohort study, comparing the functional outcomes and the retinal displacement rates between two techniques for primary rhegmatogenous retinal detachment repair: Pars Plana Vitrectomy (PPV) and Pneumatic Retinopexy (PnR).

Conditions

  • Retinal Detachment
  • Metamorphopsia
  • Aniseikonia

Interventions

PROCEDURE

Pneumatic Retinopexy

The PnR technique is performed as per the PIVOT trial under local anaesthetic. First, patients will undergo a thorough scleral-depressed peripheral retinal examination to identify all pathologic features. Second, laser retinopexy will be applied to all breaks, lattice degeneration, or both in the attached retina before gas injection. Third, breaks in the detached retina will be treated with cryotherapy before gas injection or (preferably) laser retinopexy 24 to 48 hours after gas injection, with additional laser retinopexy applied at any point per surgeon discretion. Finally, anterior chamber paracentesis will be used to express as much fluid as safely possible (generally 0.3ml), followed by intravitreal injection of 100% SF6 (ideally 0.6 ml). Patients will be positioned face down for 6 hours and then raise their head 30 degrees every hour (steam roll) and then positioned to the responsible break.

PROCEDURE

Pars Plana Vitrectomy

For PPV, a standard 3-port PPV (23 or 25-gauge) will be performed, including posterior hyaloid detachment, core vitrectomy and 360 peripheral vitreous shave. Subretinal fluid will be drained either through the peripheral break or through a posterior retinotomy with use of heavy liquid to assist with appropriate drainage at the discretion of the responsible surgeon. A complete air-fluid exchange will be performed. Endolaser Retinopexy or transconjunctival cryopexy will be performed to treat any retinal pathology, including lattice degeneration and breaks in the attached and detached retina. A iso-expansible concentration of SF6 or C3F8 gas will be injected at the completion of the surgery. Choice of gas will be at the discretion of the responsible surgeon. Patients will be positioned immediately face down for the first 24 hours and then according to the position of the responsible break.

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-27
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04089033 on ClinicalTrials.gov