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Amniotic Membrane Transplantation in Acute Severe Ocular Chemical Injury: A Randomized Clinical Trial
Medi Eslani1, Alireza Baradaran-Rafii2, Albert Y Cheung3
1Cincinnati Eye Institute, Edgewood, Kentucky, USA; Department of Ophthalmology, University of Cincinnati, Cincinnati, Ohio, USA; Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, Illinois, USA.
Insights
Amniotic membrane transplantation (AMT) combined with medical therapy did not improve corneal healing or visual acuity in severe chemical eye injuries compared to medical treatment alone. This study found no significant difference in outcomes for Roper-Hall grade IV injuries.
Area of Science:
- Ophthalmology
- Regenerative Medicine
- Trauma Care
Background:
- Ocular chemical injuries, particularly severe cases like Roper-Hall grade IV, pose significant challenges to corneal healing and visual recovery.
- Conventional medical treatments aim to manage inflammation and promote epithelialization, but outcomes can be variable.
- Amniotic membrane transplantation (AMT) has been explored as an adjunct therapy to enhance ocular surface repair.
Purpose of the Study:
- To compare the efficacy of conventional medical treatment versus a combined approach of medical treatment and amniotic membrane transplantation (AMT) for Roper-Hall grade IV ocular chemical injuries.
- To evaluate the impact of AMT on corneal epithelialization time, best-corrected visual acuity (BCVA), and neovascularization.
Main Methods:
- A randomized, parallel-controlled clinical trial was conducted with 60 patients (60 eyes) diagnosed with Roper-Hall grade IV ocular chemical injury.
- Patients were assigned to two groups: Group 1 received standard medical therapy, while Group 2 received AMT in addition to the same medical therapy.
- Outcomes including time to corneal epithelialization, BCVA, and central corneal neovascularization were assessed over a minimum follow-up of 12 months.
Main Results:
- No statistically significant difference was observed in the mean time to complete corneal epithelialization between the medical treatment group (72.6 days) and the AMT group (75.8 days) (P = .610).
- Best-corrected visual acuity (BCVA) at final follow-up was comparable between the two groups (mean logMAR 2.06 in both).
- While the medical treatment group showed a higher incidence of central corneal neovascularization (73.3%) compared to the AMT group (53.3%), this difference was not statistically significant (P = .108).
Conclusions:
- Combined amniotic membrane transplantation and medical therapy do not offer significant advantages over conventional medical therapy alone in accelerating corneal epithelialization or improving final visual acuity in severe (Roper-Hall grade IV) ocular chemical injuries.
- The findings suggest that AMT may not be a critical intervention for improving these specific outcomes in this patient population.
- Further research may be warranted to explore potential benefits of AMT in other aspects of ocular chemical injury management or in different injury grades.
Purpose:
To compare the outcomes of conventional medical treatment vs combined medical treatment and amniotic membrane transplantation (AMT) in the management of patients with Roper-Hall grade IV ocular chemical injury.
Design:
Randomized, parallel-controlled clinical trial.
Methods:
Setting: Single tertiary referral hospital.
Patients:
Sixty eyes of 60 patients with Roper-Hall grade IV ocular chemical injury with a minimum follow-up of 12 months were enrolled in the study.
Intervention:
Patients were randomly assigned to 2 groups: Group 1 (30 eyes) received topical preservative-free lubricating gel and drops, chloramphenicol, betamethasone, homatropine, oral vitamin C, and doxycycline; Group 2 (30 eyes) received amniotic membrane transplant (AMT) on the entire ocular surface in addition to the medical treatment provided in Group 1.
Outcome Measures:
The main outcome measure was time to complete corneal epithelialization. Secondary outcome measures were best-corrected visual acuity (BCVA) and neovascularization in the central 5 mm of the cornea.
Results:
Mean follow-up time was 20.3 ± 2.5 months (range 13-24 months). Corneal epithelial defects healed within 72.6 ± 30.4 (21-180) days in Group 1 vs 75.8 ± 29.8 (46-170) days in Group 2 (P = .610). Mean BCVA was 2.06 ± 0.67 (0.4-2.6) logMAR vs 2.06 ± 0.57 (1-2.9) logMAR in Groups 1 and 2, respectively (P = .85). Group 1 developed more central corneal neovascularization (22 eyes; 73.3%) compared to Group 2 (16 eyes; 53.3%); however, it was not statistically significant (P = .108).
Conclusions:
In comparison to conventional medical therapy, combined amniotic membrane transplantation and medical therapy does not accelerate corneal epithelialization or affect final visual acuity in severe chemical injuries.
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