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

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ClinicalTrials.gov Identifier: NCT04089033
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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).

Condition or disease Intervention/treatment
Retinal Detachment Metamorphopsia Aniseikonia Procedure: Pneumatic Retinopexy Procedure: Pars Plana Vitrectomy

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Retinal Displacement After Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Retinal Detachment
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : December 27, 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Primary Retinal Detachment 1
Patients presenting with primary macula-off rhegmatogenous retinal detachment being treated with Pneumatic Retinopexy
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.
Other Name: PnR

Primary Retinal Detachment 2
Patients presenting with primary macula-off rhegmatogenous retinal detachment being treated with Pars Plana Vitrectomy
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.
Other Name: PPV




Primary Outcome Measures :
  1. Retinal Displacement [ Time Frame: 3 (60 to 120 days) months ]
    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.


Secondary Outcome Measures :
  1. Visual Distortion and Metamorphopsia (M-Chart) [ Time Frame: 3 (60 to 120 days) and 12 (10-14 months) months ]
    Visual distortion is measured by M-Chart (a visual tool) evaluation and ranges from 0.2 to 2, increasing in a decimal scale of 0.2.

  2. Aniseikonia test [ Time Frame: 3 (60 to 120 days) and 12 (10-14 months) months ]
    Aniseikonia is a phenomenon in which the size or shape of perceived images differs between eyes. The anomaly is reported to be associated with interocular differences in refractive error and some retinal diseases. The Aniseikonia Test measures the ratio of image size difference between the 2 eyes by using colourful lens (green and red) and comparing the images between 2 eyes.

  3. Optical Coherence Tomography (OCT) changes [ Time Frame: 3 (60 to 120 days) and 12 (10-14 months) months ]
    A reading center will analyze the cross-sectional OCT images regarding the presence of ERM, CME, retinal layers disruption and outer/inner retinal folds.

  4. Visual Acuity (ETDRS) [ Time Frame: 12 (10-14 months) months ]
    ETDRS - 'Early treatment of Diabetic Retinopathy Study' - this study defined a method of visual acuity assessment that has become the gold standard for use in eye research) will be assessed at 12 months after the treatment for RRD. It is performed with a special chart under best-corrected visual acuity situation.

  5. Metamorphopsia questionnaire [ Time Frame: 3 (60 to 120 days) and 12 (10-14 months) months ]
    It is a self administered questionnaire regarding metamorphopsia symptoms in professional or daily activities. Patient can choose one options among the four available for each one of the 9 questions. The results range from 0 to 47 and higher results represent worse symptoms.

  6. Retinal Displacement [ Time Frame: 12 (10-14 months) months ]
    The retinal displacement is measured by the presence of retinal vessels printing (RVP) on Autofluorescence Imaging. The RVP is first classify in a YES/NO question. Then, the eyes with RVP (YES) will have the distance between RVP and retinal vessels measured on the Optos system.

  7. Foveal avascular zone (FAZ) area and findings in OCT angiography [ Time Frame: 3 (60 to 120 days) and 12 (10-14 months) months ]
    The FAZ area in the post RRD eye and in the fellow eye will be measured by 2 independent masked graders using ImageJ software. The average of the FAZ area will be compared between the PPV and PnR group, and the fellow eye (if healthy) will be used as a control.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089033


Locations
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Canada, Ontario
Department of Ophthalmology, St Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5C 2T2
Contact: Rajeev Muni    4165432127    rajeev.muni@gmail.com   
Principal Investigator: Rajeev H Muni, FRCSC         
Principal Investigator: Carolina Francisconi, MD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
  Study Documents (Full-Text)

Documents provided by St. Michael's Hospital, Toronto:
Study Protocol  [PDF] August 6, 2019


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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT04089033     History of Changes
Other Study ID Numbers: 18-085
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Michael's Hospital, Toronto:
Retinal detachment
Metamorphopsia
Aniseikonia
Retinal displacement
Additional relevant MeSH terms:
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Vision Disorders
Retinal Detachment
Aniseikonia
Dissociative Disorders
Mental Disorders
Retinal Diseases
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Refractive Errors
Temazepam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action