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Short-term outcomes of Mitomycin-C augmented phaco-trabeculectomy using subconjunctival injections versus soaked sponges: a randomized controlled trial

Eye volume 38, pages 1196–1201 (2024)Cite this article

Subjects

Abstract

Objectives

To determine whether subconjunctival Mitomycin-C (MMC) injections are as safe and effective as sponge-soaked MMC in phaco-trabeculectomy.

Methods

This prospective, randomized, interventional study was conducted on consecutive patients with visually significant cataract and an uncontrolled primary open-angle glaucoma. One hundred thirty-nine patients were recruited but 15 were ineligible for analysis. The patients were randomized into a sponge/injection group. All participants received a twin-site phaco-trabeculectomy. They were followed up on days 1, 15, 30, 3 months and 6 months post-operatively. A p-value < 0.05 was considered significant.

Interventions

Participants in the sponge group received an augmentation of their phaco-trabeculectomy with sponges soaked in a mixture of 0.04% MMC and 2% preservative-free Lignocaine in a 1:1 ratio, placed in the subconjunctival space for four minutes. Participants in the injection group received the same mixture as a subconjunctival injection, after surgical draping.

Results

There were 62 patients in each group. The groups had no significant differences in their baseline characteristics. The mean IOP at 6 months was significantly lower in the injection group (14.8 ± 3.7 mm Hg) than in the sponge group (17.1 ± 6.4 mm Hg) (p = 0.02). There was no notable difference in the complications or the final post-operative visual outcome but a significantly greater number of patients in the sponge arm required removal of the releasable suture (p = 0.001) and additional anti-glaucoma medications (p = 0.04) at six months post-operatively.

Conclusions

Subconjunctival MMC achieves a lower IOP with fewer anti-glaucoma medications than sponge-soaked MMC at six months for twin-site phaco-trabeculectomy in primary open-angle glaucoma with no additional risks.

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Fig. 1: CONSORT flowchart showing the mode of recruitment of patients.
Fig. 2: Kaplan–Meier survival curve of the two groups.

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Data availability

The dataset analyzed during the current study has not been uploaded into a repository but will be available from the corresponding author on reasonable request approved by the Tirunelveli Medical College Institutional Research Ethics Committee and Aravind Eye Hospital & PG Institute of Ophthalmology, Tirunelveli.

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Authors and Affiliations

  1. Department of Paediatric Ophthalmology and Strabismus Services, Vivekananda Mission Ashram Netra Niramay Niketan, Chaithanyapur, India

    Sabyasachi Chakrabarty

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

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

  3. Department of Cataract Services, Aravind Eye Hospital & PG Institute of Ophthalmology, Tirunelveli, India

    Shivkumar Chandrashekharan

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Contributions

SC was responsible for drafting the protocol, reviewing literature, extracting and analyzing data, interpreting the results, writing the manuscript and generating the tables and the graphs. MAK and DM were responsible for designing the study protocol, interpreting the results, and providing feedback on the manuscript. MRP, SkC and RR helped in interpreting the results and provided feedback on the manuscript. All authors approved the submitted version of the manuscript and agree to be accountable for all aspects of the work.

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Correspondence to Sabyasachi Chakrabarty.

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Chakrabarty, S., Kader, M.A., Maheshwari, D. et al. Short-term outcomes of Mitomycin-C augmented phaco-trabeculectomy using subconjunctival injections versus soaked sponges: a randomized controlled trial. Eye 38, 1196–1201 (2024). https://doi.org/10.1038/s41433-023-02869-2

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