Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202002874953456 Date of Approval: 18/02/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Non-penetrating deep sclerectomy versus trabeculectomy in primary congenital glaucoma
Official scientific title Non-penetrating deep sclerectomy versus trabeculectomy in primary congenital glaucoma
Brief summary describing the background and objectives of the trial One of the major causes of blindness in young children is congenital glaucoma. Its negligence can lead to drastic outcome despite its low incidence (one to ten thousand births approximately). Primary congenital glaucoma (PCG) is the isolated form not associated with other ocular or systemic anomalies. The aim of the current study was to evaluate the safety and efficacy of non-penetrating deep sclerectomy versus trabeculectomy in primary congenital glaucoma. a retrospective interventional comparative non randomized clinical study . The current study was approved by the local ethics committee of the faculty medicine, Alexandria University, Egypt. Tenets of the Declaration of Helsinki were followed.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2016
Actual trial start date
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nonpenetrating Deep sclerectomy surgery about less than 1 hour, follow up 3 years afterwards Non-penetrating deep sclerectomy technique: General anesthesia was used in all the cases. After a superior corneal traction suture was taken, a fornix based superior conjunctival flap was done. A rectangular 5x4.5 mm superficial scleral flap with about 1/3 thickness of the sclera was created. The dissection continued until a clear cornea is reached anteriorly. This was followed by a dissection of a 4x4 mm deeper scleral flap anteriorly to deroof Schlemm’s canal and continued further anterior in the cornea to create a trabeculo-Descemet’s window. This newly created deeper scleral flap was excised. The seepage of aqueous humor was noticed through the deroofed Schlemm’s canal. A collagen implant Ologen (Aeon Astron Europe, Leiden, The Netherlands) was used to maintain the space created and to decrease the early postoperative scarring. The implant was fixed with a single 10-0 suture. It is a biodegradable collagen implant which completely degrades within 90–180 days. 23-25 The superficial scleral flap was then sutured using 10-0 nylon sutures and the conjunctiva was sutured with 8-0 absorbable sutures. Subconjunctival injection of 5-fluorouracil was done at the end of the surgery and repeated 1 week postoperative. None of the included cases was converted to penetrating trabeculectomy. 40
Control Group Trabeculectomy surgery less than 1 hour, follow up 3 years afterwards Under general anesthesia and after a superior corneal traction suture was done, a fornix based superior conjunctival flap was created and a localized tenonectomy was done. A triangular 4x4 mm half thickness limbal based scleral flap was created. The dissection continued forward for 1-2 mm of a clear cornea. The trabeculectomy was then completed by Kelly Descemet punch followed by peripheral iredectomy. The scleral flap was then sutured using 10-0 nylon sutures (one at the apex and one suture at each side of the triangle). The conjunctiva was closed tightly with 8-0 absorbable sutures. Subconjunctival injection of 5-fluorouracil was done at the end of the surgery and repeated 1 week postoperative. 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children presenting with primary congenital glaucoma under the age of 3 years Patients were excluded if they had secondary glaucoma i.e. only eyes with PCG were included, or there was a coexisting ocular pathology e.g. congenital cataract or a previous ocular surgery. Patients with incomplete data or follow up period were also excluded. Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 3 Month(s) 3 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/04/2019 Local ethics committe Faculty of Medicine Alexandria university
Ethics Committee Address
Street address City Postal code Country
17 Champollion street, El Messalah Alexandria 21259 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The main outcome measure was the reduction in IOP. intraocular pressure measured by hand held Perkins applanation tonometer under inhalation anesthesia using Sevoflurane. 1 week, 1 month, 3, 6, 9, 12, 18, 24, 28, 36 months postoperative
Secondary Outcome Secondary outcomes included percentage of patients with complete and qualified success, need for topical antiglaucoma medications, rate of complications, and need for further interventions. Complete success of the surgical outcome was considered an IOP < 16 mmHg with no antiglaucoma medications. Qualified success was considered an IOP < 16 mmHg using antiglaucoma medications. Failure was defined as an IOP > 16 mmHg despite the use of medications, or if a need for another surgical glaucoma intervention was present. 1 week, 1 month, 3, 6, 9, 12, 18, 24, 28, 36 months postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Alexandria University Egypt Khartoum square, Raml station Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hany Helaly 30 roshdy st., roshdy alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine khartoum square Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
Abdelhamid Elhofi panorama Elsharq building, sidi gaber alexandria Egypt
hany helaly 30 roshdy st., roshdy alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdelhamid Elhofi abdelhamidelhofi@yahoo.com +201222174095 Panorama elsharq building, sidi gaber
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Ophthalmology Alexandria universiy egypt
Role Name Email Phone Street address
Public Enquiries Hany Helaly hany209209@yahoo.com +201225466733 30 roshdy street, roshdy
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant Professor of Ophthalmology Alexandria universiy egypt
Role Name Email Phone Street address
Scientific Enquiries Hany Helaly hany209209@yahoo.com +201225466733 30 roshdy street, roshdy
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant Professor of Ophthalmology Alexandria universiy egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be available (including data ) . All of the individual participant data collected during the trial, after deidentification Informed Consent Form,Study Protocol Immediately following publication, No end date. Any purpose. Anyone who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes The current study was conducted on 80 eyes. Each of the NPDS and trabeculectomy groups included 40 eyes of 40 patients with the diagnosis of primary congenital glaucoma. The NPDS group mean age was 14.5 + 13.1 months versus mean age of 13.7 + 12.2 months in the trabeculectomy group. Males represented 60 % in the NPDS group and 65% in the trabeculectomy group. There was no statistically significant difference between the two groups regarding the demographic data of the included patients. At the end of the follow up period the mean IOP was 11.2 + 4.5 and 11.1 + 3.4 mmHg with a mean reduction of 16.2 and 17.4 mmHg in NPDS and trabeculectomy groups respectively. There was a statistically significant difference between preoperative and postoperative IOP levels along the whole follow up period for both groups (p < 0.001). At the end of the follow up period i.e. at 36 months postoperative, the complete success rate was 60 % (24 eyes) versus 57.5 % (23 eyes), the qualified success rate was 25 % (10 eyes) versus 25 % (10 eyes), the overall success rate was 85 % (34 eyes) versus 82.5 % (33 eyes), and the rate of failure was 15 % (6 eyes) versus 17.5 % (7 eyes) in NPDS and trabeculectomy groups respectively 30/06/2020 01/07/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks This was a retrospective interventional comparative non randomized clinical study that included 80 eyes of 80 children presenting with primary congenital glaucoma under the age of 3 years during the period from January 2012 to December 2016. Forty eyes have undergone non-penetrating deep sclerectomy (NPDS group) and the other 40 eyes have undergone penetrating trabeculectomy (trab group). Records of the patients were revised and the children were recalled for a final follow up visit. Inclu
Changes to trial information