An interventional study of CTT with ologen® Collagen Matrix and Trab Trab in Primary Congenital Glaucoma, Developmental Glaucoma and Infantile Glaucoma, sponsored by L.V. Prasad Eye Institute. Completed at 1 site in India. Open to participants aged 1 Month to 3 Years. Per ClinicalTrials.gov, last updated 2022-04-12.
Sponsored by L.V. Prasad Eye Institute · Not applicable, Interventional, and Treatment
To the best of Investigator knowledge, no studies to this date have compared the safety and efficacy of ologen® Collagen Matrix in Primary congenital glaucoma (PCG) patients undergoing trabeculectomy. Given that filtration surgery is usually less successful in patients with developmental glaucoma; the purpose of this study is to compare combined trabeculectomy with trabeculotomy (CTT) with adjuvant ologen® Collagen Matrix versus CTT without ologen® in children with PCG. Investigator hypothesis is that CTT with ologen® Collagen Matrix would be as effective as CTT in IOP control, but with reduced scarring and long term healthier bleb morphology.
Standard combined trabeculectomy with trabeculotomy (CTT) All CTT surgeries will be performed under general anesthesia.Under aseptic surgical technique, a superior rectus suture will be placed using 4'0 silk and a limbal-based conjunctival flap to be performed. Sub-Tenon dissection and hemostasis will be achieved and a half-thickness 4 x 4mm rectangular scleralflap will to be dissected up to clear cornea, and radial incision will be placed at the location of the schemes canal, Harms trabepculotome will be used to pass into the schemes canal and rotated into the anterior chamber to open app 60 degree on either sides, A 2 × 2 mm deep scleral block will be excised and peripheral iridectomy will be performed. The scleral flap will be closed with one 10-0 nylon suture and conjunctiva will be closed with 8-0 vicryl continuous suture.
The same procedure will be done for the CTT with ologen® except, before closing the conjunctiva, the ologen® implant will be placed subconjunctivally just overlapping the apex of the triangular scleral flap
ologen® Collagen Matrix ologen® Collagen Matrix approved by Indian health authority with registration numberof MD-1517 (valid till Mar-15-2018) will be provided by Aeon Ajanta India Pvt. Ltd. free of cost for this clinical research only.
35 studies on the registry are indexed under Hydrophthalmos; 3 are open to participants now.
This study's enrollment of 44 is above the median of 33 across 28 interventional studies indexed under Hydrophthalmos.
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Experimental: Trabeculotomy with trabeculectomy with ologen implant
Procedure: CTT with ologen® Collagen Matrix
Active Comparator: Trabeculotomy with trabeculectomy
Procedure: Trab Trab
ologen® Collagen Matrix approved by Indian health authority with registration numberof MD-1517 will be provided by Aeon Ajanta India Pvt. Ltd. free of cost for this clinical research only.
Also known as: Ologen with combined trabeculotomy and trabeculectomy
combined trabeculotomy with trabeculectomy
Also known as: combined trabeculotomy with trabeculectomy
Comparing IOP control between the two groups:Change of intraocular pressure (IOP) over time
Assess control of IOP over time. "Complete success" is defined as IOP reduction of \>20% and / or an IOP constantly \<21 mmHg without any antiglaucoma medication. "Qualified success" is defined as IOP \< 21 mmHg with topical antiglaucoma medication. "Failure" is defined as IOP \> 21mmHg in 2 subsequent follow visits despite topical antiglaucoma medication.
Time frame: 12 months
Comparing bleb morphology in two groups by change of Moorfields Bleb Grading System (MBGS) score over time
Assess bleb characteristics using Moorfields Bleb Grading System (MBGS) score as measurement tool to document bleb grading score over time, clinically and with photographs
Time frame: 12 months
Ran from Jul 2018 to primary completion in Sep 2019, 13 months.
Of 12 interventional studies with no phase under Hydrophthalmos, half reached primary completion within 23 months of starting (the median); a quarter within 18 and three quarters within 25. This study's 13 months is below that.
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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L.V. Prasad Eye Institute