Ex-PRESS Implantation versus Trabeculectomy for Long-Term Maintenance in Patients with Open-Angle Glaucoma

Abstract

Purpose

To compare the efficacy of Ex-PRESS implantation (EXP) with that of trabeculectomy (TLE) with mitomycin C for maintaining low target intraocular pressure (IOP) in patients with open-angle glaucoma.

Patients and Methods

Patients were randomly assigned to receive EXP or TLE. Surgical success was defined according to three target mean IOP ranges (5 mmHg ≤ IOP ≤ 18 mmHg [criterion A], 5 mmHg ≤ IOP ≤ 15 mmHg [criterion B], and 5 mmHg ≤ IOP ≤ 12 mmHg [criterion C]) representing reductions of at least 20% below the baseline on two consecutive follow-up visits 3 months post-surgery, with or without antiglaucoma medication and without further glaucoma surgery. Participants were divided into three subgroups based on baseline mean deviation (MD) values: early (MD ≥ −6 dB), moderate (−6 dB > MD ≥ −12 dB), and advanced (−12 dB > MD). Survival rates were calculated by subgroup.

Results

A total of 73 patients, including 30 in the EXP group and 43 in the TLE group, were included in the study. No significant differences in baseline ocular or demographic characteristics were found between the two groups. No significant difference in IOP was noted every 6 months. After the 3-year follow-up, success rates were A) 60.0% and 60.2%, B) 45.7% and 58.1%, and C) 31.5% and 40.5% for the EXP and TLE groups, respectively. Moreover, there was no difference in success rate based on glaucoma level. Many glaucoma medications administered before surgery were associated with a higher failure rate in the TLE group but not in the EXP group.

Conclusion

Both procedures resulted in similar IOP reductions and success rates for a low target IOP. The number of preoperative glaucoma medications was a risk factor for TLE failure.

Keywords:

• filtration surgery
• glaucoma
• randomized controlled clinical trial
• visual field

Abbreviations

EXP, Ex-PRESS; IOP, Intraocular pressure; MD, Mean deviation; NTG, Normal-tension glaucoma; OAG, Open-angle glaucoma; SD, Standard deviation; VA, Visual acuity.

Data Sharing Statement

The data that support the findings of this study are available from the corresponding author, Kana Tokumo, upon reasonable request.

Ethics Approval and Informed Consent

The Institutional Review Board of Hiroshima University Hospital approved the study protocol before the recruitment began. This study was registered with the University Hospital Medical Information Network Clinical Trials Registry of Japan (Identifier University Hospital Medical Information Network 000008981; date of access and registration, September 25, 2012). The study followed the tenets of the Declaration of Helsinki.

Consent for Publication

Written informed consent was obtained from all patients before the surgical procedure.

Acknowledgments

The authors would like to thank Enago for the English language review.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all of these areas; took part in drafting, revising, or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The authors report no conflicts of interest in this work.

Additional information

Funding

The authors did not receive support from any organization for the submitted work.