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
|Condition or disease||Intervention/treatment|
|Retinal Detachment Metamorphopsia Aniseikonia||Procedure: Pneumatic Retinopexy Procedure: Pars Plana Vitrectomy|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||180 participants|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089033
|Department of Ophthalmology, St Michael's Hospital||Recruiting|
|Toronto, Ontario, Canada, M5C 2T2|
|Contact: Rajeev Muni 4165432127 firstname.lastname@example.org|
|Principal Investigator: Rajeev H Muni, FRCSC|
|Principal Investigator: Carolina Francisconi, MD|