Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05014386 |
| Other study ID # |
AGV with ologen in SPG |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 2021 |
| Est. completion date |
January 2024 |
Study information
| Verified date |
August 2021 |
| Source |
Mansoura University |
| Contact |
Amr Mohammed Elsayed A Mohammed, MD, FRCS |
| Phone |
01004314242 |
| Email |
dramrabdelkader[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Ahmed Glaucoma Valve Implantation with Ologen augmentation in secondary pediatric glaucomas:
A 2-year randomized controlled trial.
Background:
Many studies have investigated the clinical benefits of Ologen for trabeculectomy. However,
its benefits for Ahmed glaucoma valve implantation have not been widely investigated.
Purpose:
The aim of this study was to compare the 2-year outcomes of AGV implantation with and without
Ologen adjuvant for the treatment of children with 2ry pediatric glaucoma. Design: This is a
single-center, randomized, controlled study. Participants: Consecutive children with
refractory pediatric glaucoma requiring AGV implantation were enrolled in this study.
Methods:
Refractory pediatric glaucoma was defined by at least 2 repeated IOP measurements greater
than 21 mmHg and accompanying signs of buphthalmos, corneal edema, Haabs striae, or optic
nerve cupping despite maximal tolerated medical therapy. The primary outcome measure was AGV
success. Complete success was defined as intraocular pressure (IOP) between 6 and 20 mmHg
without glaucoma medications and additional IOP-lowering surgeries. Qualified success was
defined as above, except IOP control maintained with glaucoma medications. In Ologen eyes, a
round 12 × 1 mm circular Ologen disc will be placed over the FP7 or FP8 AGV-plate immediately
before conjunctival closure. Control eyes received conventional FP7 or FP8 AGV surgery
without Ologen augmentation.
Description:
Ahmed Glaucoma Valve Implantation with Ologen augmentation in secondary pediatric glaucomas:
A 2-year randomized controlled trial.
Background:
The management of secondary pediatric glaucoma is challenging in terms of maintaining
lifelong vision and avoiding an aggressive scarring course after surgery. Secondary Pediatric
glaucoma includes a variety of ocular conditions that lead to high intraocular pressure (IOP)
and progressive optic neuropathy. Glaucoma is a well-known complication of congenital
cataract extraction and is the most frequent long-term complication of lensectomy with or
without intraocular lens (IOL) implantation. The reported incidence in the literature is
between 15% and 45%4. Another cause is aphakic glaucoma.Management of secondary pediatric
glaucoma is mainly surgical, and medical therapy is used either as a temporizing measure or
as an adjunctive treatment.
Traditionally, "staged approach" has been favored by many ophthalmologists. This involves
starting with angle surgeries and their repetition in the case of failure, proceeding with
trabeculectomy or combined trabeculotomy-trabeculectomy for refractory patients, and drainage
device or cyclodestruction for very advanced patients.The poor clinical outcomes prompted
surgeons to adapt glaucoma drainage devices (GDDs) as a mainstay of treatment for refractory
glaucoma in both pediatric and adult populations.In children, Ahmed glaucoma valves (AGV)
have greater than 80% success rate at 1- year, but success decreases to less than 50% by 5
years2. In order to improve long-term IOP control, mitomycinC (MMC) has been used as an
adjuvant during implant placement. While MMC is a commonplace in trabeculectomy, its use with
GDDs is controversial due to increased complications such as bleb leaks and endothelial cell
damage. More recently, Ologen, a biodegradable Type-I collagen matrix, has been used in
glaucoma surgeries. Ologen is safe and effective in enhancing trabeculectomy surgery in
adults and children,.
Many studies have investigated the clinical benefits of Ologen for trabeculectomy. However,
its benefits for Ahmed glaucoma valve implantation have not been widely investigated. Reports
in adult patients have shown that Ologen may increase AGV success and decrease hypertensive
phase incidence. Many studies have investigated the clinical benefits of Ologen for
trabeculectomy. However, its benefits for Ahmed glaucoma valve implantation have not been
widely investigated. As glaucoma drainage devices are being increasingly used for pediatric
glaucoma,investigators decided to report the results and safety of Ahmed glaucoma valve (AGV)
implantation in a series of secondary pediatric glaucoma as well as the clinical benefits of
concomitant use Ologen as an adjuvant for for Ahmed glaucoma valve implantation .
Purpose:
The aim of this study was to compare the 2-year outcomes of AGV implantation with and without
Ologen adjuvant for the treatment of children with 2ry pediatric glaucoma.
Design:
This is a single-center, randomized, controlled study.
Participants:
Consecutive children with refractory pediatric glaucoma requiring AGV implantation were
enrolled in this study.
Methods:
Refractory pediatric glaucoma was defined by at least 2 repeated IOP measurements greater
than 21 mmHg and accompanying signs of buphthalmos, corneal edema, Haabs striae, or optic
nerve cupping despite maximal tolerated medical therapy. The primary outcome measure was AGV
success. Complete success was defined as intraocular pressure (IOP) between 6 and 20 mmHg
without glaucoma medications and additional IOP-lowering surgeries. Qualified success was
defined as above, except that IOP control was maintained with glaucoma medications.
Surgical procedure:
A 7-0 silk traction suture was placed through the clear cornea.A conjunctival incision was
made 4 mm posterior to the limbus in the supratemporal quadrant. After dissecting conjunctiva
and Tenon's primed FP7 or FP8 AGV was inserted into the subconjunctival space and sutured to
sclera using two interrupted 7-0 silk sutures 8-10 mm posterior to the limbus. A 23-gauge
needle was used to enter the anterior chamber from the surgical limbus. The tube then was cut
beveled up and inserted into the anterior chamber through the tunnel. In Ologen eyes, a round
12 × 1 mm circular Ologen disc will be placed over the FP7 or FP8 AGV-plate immediately
before conjunctival closure. Control eyes received conventional FP7 or FP8 AGV surgery
without Ologen augmentation.
Finally, conjunctiva and Tenon were approximated using a running 8-0 Vicryl suture.At the
close of surgery, subtenon antibiotic and steroids were injected in all cases.
Data collection:
Preoperative data including age at the time of surgery, sex,laterality, type of glaucoma,
prior ocular history, prior surgical treatment, number of glaucoma medications, IOP, cup to
disc ratio, and central corneal thickness (CCT) were extracted from patients' record.
Postoperative data included follow-up durations; IOP at months 3, 6, 12, 24, and 36; cup to
disc ratios at months 12, 24,; and intraoperative and postoperative complications. In all
cases, IOPs were measured by Tono-Pen (Mentor, Woburn, MA, USA) under anesthesia. In the
clinic, IOPs were measured by ICare (ICare Finland Oy, Helsinki, Finland) and Goldmann
applanation tonometer (Haag-Streit, Köniz, Switzerland).
Statistical analysis:
All statistical analysis was accomplished using IBM SPSS version 20. Assessment of the data
normality was done using both Histogram plot and Shapiro-Wilk's test. Wilcoxon test was used
to compare the preoperative and postoperative variables in each group. The comparison between
the two groups was done using Mann-Whitney test for numerical variables and Chi-square test
for categorical variables. Kaplan-Meier survival curve was plotted to estimate the mean
survival time and probabilities of failure at different follow-up stages in the both groups.
For all tests, P value of less than 0.05 was considered significant.
