Abstract
Purpose
To evaluate the efficacy and safety of using Mitomycin-C (MMC) or Ologen implant as an adjunct to combined trabeculotomy–trabeculectomy (CTT) surgery relative to non-augmented CTT surgery in achieving higher success rates in patients with primary congenital glaucoma (PCG).
Study design
A prospective triple-armed randomized controlled clinical trial was conducted in the period between April 2019 and May 2021, targeting 75 eyes of patients with PCG over one year, with patients being followed up for at least one whole year.
Patients and methods
The study included 75 eyes; only 70 fulfilled the inclusion criteria and were randomly assigned to one of the three study groups using a computer program to generate random number list. Eyes were treated by either CTT without augmentation, CTT augmented with MMC, or CTT augmented with Ologen implant. Only 63 eyes completed one year of follow-up and were evenly distributed among the three study groups; with 21 eyes in each group were statistically analyzed.
Outcome measures
Our primary outcome measure is to report and compare the percentage of patients who demonstrated complete success with intraocular pressure (IOP) controlled and maintained below 21 mmHg without the use of antiglaucoma medications or additional glaucoma surgery over a one-year follow-up. Secondary outcome measures include reporting failure, intra- and postoperative complications of the three surgical modalities, postoperative corneal diameter, clearance of corneal edema, and postoperative cup/disk (C/D) ratio.
Results
Complete success was achieved in 17 eyes (81.0%) in CTT group, 18 eyes (85.7%) in MMC group, and 17 eyes (81.0%) in Ologen group. Qualified success (IOP < 21 with or without antiglaucoma medications) was achieved in 18 eyes (85.7%) in both the CTT and the Ologen groups, with 19 eyes (90.5%) in the MMC group. Failure was observed in three eyes (14.3%) in both CTT and Ologen groups and two eyes (9.5%) in the MMC group. Based on survival analysis, CTT group had a cumulative success probability of 95.2% at three months, which dropped to 85.7% at six months and remained at that level for the 9th and 12th months of follow-up. With respect to the MMC group, the cumulative success probability at three months was 95.2%, dropped to 90.5% at six months, and remained at that level for the 9th and 12th months of follow-up. While in the Ologen group, the cumulative success probability at three months was 85.7% and remained at the same level during the 6th, 9th, and 12th months of follow-up, with p value = 0.862 using the logrank test.
Conclusion
CTT is a safe and effective primary surgical intervention in patients with PCG without the need for augmentation while preserving the augmented procedure's use for recurrent cases.
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References
deLuise VP, Anderson DR (1983) Primary infantile glaucoma (congenital glaucoma). Surv Ophthalmol 28(1):1–19. https://doi.org/10.1016/0039-6257(83)90174-1
Yeung HH, Walton DS (2010) Clinical classification of childhood glaucomas [published correction appears in Arch Ophthalmol. 2010 Sep;128(9):1225]. Arch Ophthalmol. 128(6):680–684.https://doi.org/10.1001/archophthalmol.2010.96
Badawi AH, Al-Muhaylib AA, Al Owaifeer AM, Al-Essa RS, Al-Shahwan SA (2019) Primary congenital glaucoma: an updated review. Saudi J Ophthalmol 33(4):382–388. https://doi.org/10.1016/j.sjopt.2019.10.002
Papadopoulos M, Edmunds B, Fenerty C, Khaw PT (2014) Childhood glaucoma surgery in the 21st century. Eye (Lond) 28(8):931–943. https://doi.org/10.1038/eye.2014.140
Elder MJ, De Cock R (1993) Childhood blindness in the West Bank and Gaza Strip: prevalence, aetiology and hereditary factors. Eye (Lond) 7(Pt 4):580–583. https://doi.org/10.1038/eye.1993.126
Papadopoulos M, Cable N, Rahi J, Khaw PT, BIG Eye Study Investigators (2007) The British Infantile and Childhood Glaucoma (BIG) Eye Study. Invest Ophthalmol Vis Sci. 48(9):4100–4106. https://doi.org/10.1167/iovs.06-1350
Alanazi FF, Song JC, Mousa A, Morales J, Al Shahwan S, Alodhayb S, Al Jadaan I, Al-Turkmani S, Edward DP (2013) Primary and secondary congenital glaucoma: baseline features from a registry at King Khaled Eye Specialist Hospital, Riyadh. Saudi Arabia Am J Ophthalmol 155(5):882–889. https://doi.org/10.1016/j.ajo.2012.12.006
Elder MJ (1994) Combined trabeculotomy-trabeculectomy compared with primary trabeculectomy for congenital glaucoma. Br J Ophthalmol 78(10):745–748. https://doi.org/10.1136/bjo.78.10.745
Al-Hazmi A, Awad A, Zwaan J, Al-Mesfer SA, Al-Jadaan I, Al-Mohammed A (2005) Correlation between surgical success rate and severity of congenital glaucoma. Br J Ophthalmol 89(4):449–453. https://doi.org/10.1136/bjo.2004.047761
Russell-Eggitt IM, Rice NS, Jay B, Wyse RK (1992) Relapse following goniotomy for congenital glaucoma due to trabecular dysgenesis. Eye (Lond) 6(Pt 2):197–200. https://doi.org/10.1038/eye.1992.38
Yalvac IS, Satana B, Suveren A, Eksioglu U, Duman S (2007) Success of trabeculotomy in patients with congenital glaucoma operated on within 3 months of birth. Eye (Lond) 21(4):459–464. https://doi.org/10.1038/sj.eye.6702223
Mandal AK, Bhatia PG, Bhaskar A, Nutheti R (2004) Long-term surgical and visual outcomes in Indian children with developmental glaucoma operated on within 6 months of birth. Ophthalmology 111(2):283–290. https://doi.org/10.1016/j.ophtha.2003.05.027
Mandal AK, Matalia JH, Nutheti R, Krishnaiah S (2006) Combined trabeculotomy and trabeculectomy in advanced primary developmental glaucoma with corneal diameter of 14 mm or more. Eye (Lond) 20(2):135–143. https://doi.org/10.1038/sj.eye.6701817
Mullaney PB, Selleck C, Al-Awad A, Al-Mesfer S, Zwaan J (1999) Combined trabeculotomy and trabeculectomy as an initial procedure in uncomplicated congenital glaucoma. Arch Ophthalmol 117(4):457–460. https://doi.org/10.1001/archopht.117.4.457
Hsu CR, Chen YH, Tai MC, Lu DW (2018) Combined trabeculotomy-trabeculectomy using the modified Safer Surgery System augmented with MMC: its long-term outcomes of glaucoma treatment in Asian children. Graefes Arch Clin Exp Ophthalmol 256(6):1187–1194. https://doi.org/10.1007/s00417-018-3941-9
Cillino S, Casuccio A, Di Pace F, Cagini C, Ferraro LL, Cillino G (2016) Biodegradable collagen matrix implant versus mitomycin-C in trabeculectomy: five-year follow-up. BMC Ophthalmol 16:24. https://doi.org/10.1186/s12886-016-0198-0
Singab AAS, Mohammed OA, Saleem MIH, Abozaid MA (2017) A comparative study: the use of collagen implant versus Mitomycin-C in combined trabeculotomy and trabeculectomy for treatment of primary congenital glaucoma. J Ophthalmol 2017:9241459. https://doi.org/10.1155/2017/9241459
Elhefney EM, Al-Sharkawy HT, Kishk HM, Abouelkheir H (2017) Safety and efficacy of collagen matrix implantation in infantile glaucoma. Eur J Ophthalmol 27(3):289–294. https://doi.org/10.5301/ejo.5000859
Mandal AK, Naduvilath TJ, Jayagandan A (1998) Surgical results of combined trabeculotomy-trabeculectomy for developmental glaucoma. Ophthalmology 105(6):974–982. https://doi.org/10.1016/S0161-6420(98)96022-5
Essuman VA, Braimah IZ, Ndanu TA, Ntim-Amponsah CT (2011) Combined trabeculotomy and trabeculectomy: outcome for primary congenital glaucoma in a West African population. Eye (Lond) 25(1):77–83. https://doi.org/10.1038/eye.2010.156
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Khairy, M.A., Kenawy, S., Fawzi, K.M. et al. Combined trabeculotomy–trabeculectomy with and without augmentation in primary congenital glaucoma: triple-armed randomized controlled trial. Int Ophthalmol 43, 1591–1600 (2023). https://doi.org/10.1007/s10792-022-02558-1
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DOI: https://doi.org/10.1007/s10792-022-02558-1