Surgical treatment of retinal detachment with and without combined cataract extraction
| ISRCTN | ISRCTN15940019 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15940019 |
| Secondary identifying numbers | 569/2018 |
- Submission date
- 21/12/2020
- Registration date
- 15/01/2021
- Last edited
- 03/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Rhegmatogenous retinal detachment (RRD) is a potentially blinding eye disease resulting from the separation of the neurosensory retina from the retinal pigment epithelium because of formation of a retinal break and entry of fluid from the vitreous cavity to the subretinal space. RRD is largely more common in adults with myopia or an artificial lens, but it can affect younger patients, particularly those with risk factors such as eye trauma or hereditary abnormalities.
Parsplana vitrectomy (PPV) is nowadays the primary surgical procedure to obtain the repair of the RRD. For eyes that still have their natural lens, PPV can be performed with or without removing the lens, and previous studies have reported advantages and drawbacks for both approaches. The lens can be removed by phacoemulsification, a procedure in which an ultrasonic device is used to break up and then remove a cloudy lens. The aim of this study is to compare PPV with or without phacoemulsification in terms of anatomical success and functional outcomes.
Who can participate?
Patients aged 48 - 65 years scheduled for vitreoretinal surgery to treat RRDto treat rhegmatogenous retinal detachment (RRD).
What does the study involve?
Patients scheduled for vitreoretinal surgery to treat a recent RRD, after a full ophthalmological evaluation, receive PPV with or without phacoemulsification. The patients are then asked to undergo postoperative eyedrop therapy and follow up with complete visits at 1 week, 1, 3 and 6 months after the PPV procedure.
What are the possible benefits and risks of participating?
Benefits of PPV with phacoemulsification might be better visualization and access during surgery and therefore a reduced need for a second surgery. However, there are also disadvantages as there is a risk of postoperative visual errors such as blurred vision and uneven focussing between the two eyes, and can lead to the removal of a largely healthy organ in cases of no/mild cataract.
Where is the study run from?
University Hospital of Parma (Italy)
When is the study starting and how long is it expected to run for?
December 2017 to December 2021
Who is funding the study?
Università degli Studi di Parma (Italy)
Who is the main contact?
Paolo Mora
paolo.mora@unipr.it
Contact information
Scientific
Ophthalmology Unit - University Hospital of Parma
parma
43126
Italy
 ORCID ID |
0000-0001-7133-8250 |
|---|---|
| Phone | +39 (0)521 703138 |
| paolo.mora@unipr.it |
Study information
| Study design | Hospital-based, prospective randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, written in Italian (please use contact details to request a participant information sheet) |
| Scientific title | Parsplana vitrectomy alone versus parsplana vitrectomy combined with phacoemulsification for the treatment of rhegmatogenous retinal detachment: a randomized study |
| Study objectives | To compare the anatomical success rate, defined as retinal reattachment 6 months after primary surgery without reoperation between parsplana vitrectomy alone versus parsplana vitrectomy combined with phacoemulsification. |
| Ethics approval(s) | Approved 27/08/2018, Comitato Etico dell’Area Vasta Emilia Nord– Sede Locale Di Parma (Segreteria Locale di Parma, Via Gramsci 14 – 43126 Parma, Italy; +39.0521 703013/703608; comitatoetico@ao.pr.it), ref: 569/2018 |
| Health condition(s) or problem(s) studied | Rhegmatogenous retinal detachment treated by parsplana vitrectomy (PPV) |
| Intervention | Group A: Lens-sparing technique (PPV-only) Group B: Phacovitrectomy Postoperative follow up: 6 months The method of randomisation was “equal simple randomisation”. Group A: Lens-sparing technique (PPV-only). PPV will be performed using a binocular indirect ophthalmomicroscope (BIOM; Oculus, Wetzlar, Germany) for noncontact, wide-angle surgery. A 25-gauge trocar with a valved cannula will be inserted transconjunctivally in the inferotemporal, superotemporal, and superonasal quadrants, 4 mm posterior to the limbus. During the procedure, core vitrectomy is initially performed. When the posterior hyaloid is attached to the posterior pole, detachment will be performed using the vitreous probe at an aspiration rate of 400 mmHg. Perfluorocarbon liquid (PFCL) will be injected intravitreally up to around 2 disc diameters from the posterior edge of the less peripheral tear, to promote internal subretinal fluid drainage during fluid-air exchange. Cryopexy will be used to freeze areas around the retinal breaks and those adjacent to the sclerotomies. Fluid–air exchange will be performed to remove all balanced saline solution and PFCL before gas tamponade (C3F8 at 18%). At the end of surgery, all trocars are removed and sutures placed according to the watertight nature of the holes. A subconjunctival injection of 0.2 mL of gentamicin and dexamethasone solution will be administered before the lid speculum is removed. Group B: Phacovitrectomy. Standard phacoemulsification will be performed systematically before the PPV through a 2.2-mm clear corneal incision, with implantation of a hydrophobic, acrylic, foldable monofocal IOL. The subsequent vitrectomy procedure is the same as that mentioned above, except that argon endolaser treatment of the breaks is used instead of cryopexy. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Anatomical success rate, defined as retinal reattachment 6 months after primary surgery without reoperation (postoperative argon laser treatment on areas considered to be at risk for new rhegmatogenous events was not considered as reoperation), measured using fundoscopy at 1, 3, and 6 months |
| Secondary outcome measures | 1. Final best-corrected visual acuity (BCVA) measured using the Early Treatment Diabetic Retinopathy Study chart at 4 meters at 1, 3, and 6 months 2. Intraocular pressure (IOP) (in mmHg) measured using the Goldmann applanation tonometry at 1, 3, and 6 months 3. Central macular thickness (CMT) (in micrometers) measured using on Optical Coherence Tomography scan at 1, 3, and 6 months 4. Progression of the cataract (group A only) measured using the LOCS III scale at 1, 3, and 6 months |
| Overall study start date | 01/12/2017 |
| Completion date | 01/07/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | By accepting a type I error of 5% and a type II error of 20% (i.e. a study power of 80%), a total sample size of 50 units (2 groups of 25 units) was required |
| Total final enrolment | 64 |
| Key inclusion criteria | 1. Aged 48–65 years with RRD in phakic eyes 2. The presence of up to three separate retinal tears within the superior 180° of the retinal circumference with an overall extension of retinal breaks <90° 3. Proliferative vitreoretinopathy (PVR) not exceeding the grade B according to the updated classification of 1991 4. Lens opacity not exceeding the first grade of each category of the Lens Opacities Classification System III (LOCS III) scale |
| Key exclusion criteria | 1. Previous surgery in the affected eye (excluding corneal refractive procedures) 2. Current use of topical hypotensive medications 3. Documented diabetic or hypertensive retinopathy 4. Age-related maculopathy 5. Optic nerve vascular pathologies |
| Date of first enrolment | 01/12/2018 |
| Date of final enrolment | 31/12/2021 |
Locations
Countries of recruitment
- Italy
Study participating centre
Department of Medicine and Surgery
via Gramsci 14
Parma
43126
Italy
Sponsor information
University/education
via Gramsci 14
Parma
43126
Italy
| Phone | +39 (0)521 703138 |
|---|---|
| paolo.mora@unipr.it | |
| Website | http://en.unipr.it/ |
"ROR" |
https://ror.org/02k7wn190 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- Università di Parma, University of Parma, UNIPR
- Location
- Italy
Results and Publications
| Intention to publish date | 01/03/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | A publication of the ad interim results and of the full data is planned in a high-impact peer-reviewed journal. The protocol is stored up in online and paper version by the Local Ethics Committee. Referring to a monocentric local study the protocol is written in Italian. |
| IPD sharing plan | For access to the dataset please contact Paolo Mora, email: paolo.mora@unipr.it and/or Lucia Benatti email: lucia.benatti.90@gmail.com. The results of each follow up visit is reported in the medical chart and then entered in the Excel database available in a computer file accessible for the two people mentioned above. Once anonymized (only initials) data will be shared with the statistician for statistical analyses. Signed informed consents are preserved in a binder in the office of the PI (PM). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/05/2021 | 05/05/2021 | Yes | No |
Editorial Notes
03/02/2022: The total final enrolment number has been changed from 59 to 64.
05/05/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
23/12/2020: Trial’s existence confirmed by Comitato Etico dell’Area Vasta Emilia Nord.
