NCT04089033

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 13, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

2.8 years

First QC Date

August 26, 2019

Last Update Submit

December 9, 2022

Conditions

Retinal DetachmentMetamorphopsiaAniseikonia

Keywords

Retinal detachmentMetamorphopsiaAniseikoniaRetinal displacement

Outcome Measures

Primary Outcomes (1)

  • Retinal Displacement

    The retinal displacement is assessed by the presence of retinal vessels printing (RVP) on Autofluorescence Imaging. FAF imaging will be assessed by 2 independent masked graders, who will indicate in retinal displacement is present or not. On those images that retinal displacement is noted, the distance between RVP and retinal vessels will be measured on the Optos system.

    3 (60 up to 120 days) months

Secondary Outcomes (7)

  • Visual Distortion and Metamorphopsia (M-Chart)

    3 (60 up to 120 days) and 12 (10 up to 14 months) months

  • Aniseikonia test

    3 (60 up to 120 days) and 12 (10 up to 14 months) months

  • Optical Coherence Tomography (OCT) changes

    3 (60 up to 120 days) and 12 (10 cup to 14 months) months

  • Visual Acuity (ETDRS)

    12 (10 up to 14 months) months

  • Metamorphopsia questionnaire

    3 (60 up to 120 days) and 12 (10 up to14 months) months

  • +2 more secondary outcomes

Study Arms (2)

Primary Retinal Detachment 1

Patients presenting with primary macula-off rhegmatogenous retinal detachment being treated with Pneumatic Retinopexy

Procedure: Pneumatic Retinopexy

Primary Retinal Detachment 2

Patients presenting with primary macula-off rhegmatogenous retinal detachment being treated with Pars Plana Vitrectomy

Procedure: Pars Plana Vitrectomy

Interventions

Pneumatic RetinopexyPROCEDURE

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.

Also known as: PnR
Primary Retinal Detachment 1
Pars Plana VitrectomyPROCEDURE

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.

Also known as: PPV
Primary Retinal Detachment 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presenting to St. Michaels Hospital retinal service with rhegmatogenous retinal detachment. Eligibility for study participation will be ascertained by the examining physician at the time of presentation

You may qualify if:

  • Age ≥ 18
  • Diagnosis of macula off primary rhegmatogenous retinal detachment

You may not qualify if:

  • Previous retinal detachment and/or retinal detachment repair surgery in the study eye
  • Retinal detachment with macula on.
  • Patients with other retinal pathologies causing structural changes to the retina in the study eye, such as diabetic retinopathy, previous vascular occlusion (artery or vein occlusion), macular dystrophy, among others.
  • Previous vitreoretinal surgery in the study eye
  • Inability to come for follow ups up to 12 months.
  • Inability to take FAF imaging due to neck stiffness or other medical issue.
  • Inability to maintain post operation head positioning
  • Mental incapacity
  • Inability to sign on informed consent.
  • Patient is unwilling or unable to follow or comply with all study related procedures or to sign informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, St Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (1)

  • Bansal A, Naidu SC, Marafon SB, Kohler JM, In S, Mahendrakar PA, Garima, Kashyap H, Susavar P, Bhende M, Ryan EH, Muni RH. Retinal Displacement after Scleral Buckle versus Combined Buckle and Vitrectomy for Rhegmatogenous Retinal Detachment: ALIGN Scleral Buckle versus Pars Plana Vitrectomy with Scleral Buckle. Ophthalmol Retina. 2023 Sep;7(9):788-793. doi: 10.1016/j.oret.2023.05.012. Epub 2023 May 20.

    PMID: 37217137DERIVED

MeSH Terms

Conditions

Retinal DetachmentVision DisordersAniseikonia

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRefractive Errors

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2019

First Posted

September 13, 2019

Study Start

June 27, 2018

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

December 13, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)