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Long-term outcomes of Mitomycin-C augmented trabeculectomy using subconjunctival injections versus soaked sponges: a randomised controlled trial

Eye volume 38, pages 968–972 (2024)Cite this article

Subjects

Abstract

Purpose

To compare the safety and efficacy of subconjunctival injection of Mitomycin C(MMC) with sponge-applied MMC during trabeculectomy.

Methods

This prospective, randomised, interventional study was conducted on consecutive patients with uncontrolled glaucoma. 137 patients were randomised into an Injection group (Group 1, n = 66) and a sponge group (Group 2, n = 71). Trabeculectomy was performed in all patients who were followed up on days 1, 15, 30, 3 months, 6 months, 1 year, 2 years & 3 years postoperatively. Baseline & follow-up visits were compared to find out difference in the number of antiglaucoma medications (AGM), Intraocular pressure (IOP), and Best Corrected Visual Acuity (BCVA). In Group 1, the surgeon used MMC 0.2 mg/ml as subconjunctival injection and two separate semicircular surgical sponges soaked with MMC solution of 0.2 mg/mL were inserted subconjunctivally in Group 2.

Results

Mean preop IOP was 34.21 ± 13.3 mmHg & 34.17 ± 10.6 mmHg in group 1 & 2 respectively, which reduced to 11.34 ± 3.7& 12.57 ± 4.7 mmHg(6 months),11.97 ± 4.2 & 13.60 ± 5.3 mmHg(1 year),12.42 ± 4.4 & 11.77 ± 2.8 mmHg (2 years) &11.25 ± 3.2 & 11.81 ± 3.2 mmHg at final visit(P < 0.001 in both groups)with no significant difference between the groups. The mean number of preoperative AGM was 2.32 ± 0.7 & 2.32 ± 0.8 in group1 & 2 respectively which reduced to 0.78 ± 0.9 (P < 0.001) & 1.13 ± 1.1(P = 0.930) at 3 years. Overall success rates were 75.3% in group 1 and 70.7% in group 2 at 3 years(p = 0.512). Postoperative complications and the final post-operative visual outcomes were similar between the groups.

Conclusion

Subconjunctival Injection of MMC is as safe and effective as sponge application with comparable surgical outcomes and complications in the long term.

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Data availability

The data that support the findings of this study are available on request from the corresponding author and approval by the Clinical Audit Committee of the institute. The data are not publicly available due to them containing information that could compromise research participant privacy.

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Authors and Affiliations

  1. Department of Glaucoma, Aravind Eye Hospital & PG Institute of Ophthalmology, Tirunelveli, India

    Devendra Maheshwari, Madhavi Ramanatha Pillai, Priya HM, Rengappa Ramakrishnan & Mohideen Abdul Kader

  2. Department of Pediatric Ophthalmology, Aravind Eye Hospital & PG Institute of Ophthalmology, Tirunelveli, India

    Neelam Pawar

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  1. Devendra Maheshwari
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  3. Priya HM
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  4. Rengappa Ramakrishnan
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  5. Mohideen Abdul Kader
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Contributions

CONCEPTION: Constructing an idea or hypothesis for research and/or manuscript: DM, MRP. DESIGN: Planning methodology to reach the conclusion: DM, MRP. SUPERVISION: Organising and supervising the course of the project or the article and taking the responsibility: DM, MRP, RR, MAK, NP. FUNDINGS: Providing personnel, environmental and financial support and tools and instruments that are vital for the project: NIL. MATERIALS: Biological materials, reagents and referred patients: DM, RR, MAK. DATA COLLECTION AND/OR PROCESSING: Taking responsibility in execution of the experiments, patient follow-up, data management and reporting: DM, MRP, PHM. ANALYSIS AND/OR INTERPRETATION: Taking responsibility in logical interpretation and presentation of the results: DM, MRP. LITERATURE REVIEW: Taking responsibility in this necessary function: DM, MRP, PHM. WRITER: Taking responsibility in the construction of the whole or body of the manuscript: DM, MRP. CRITICAL REVIEW: Reviewing the article before submission not only for spelling and grammar but also for its intellectual content.: DM, MRP, NP. OTHER.

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Correspondence to Devendra Maheshwari.

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Maheshwari, D., Pillai, M.R., HM, P. et al. Long-term outcomes of Mitomycin-C augmented trabeculectomy using subconjunctival injections versus soaked sponges: a randomised controlled trial. Eye 38, 968–972 (2024). https://doi.org/10.1038/s41433-023-02816-1

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