Comparative Treatment Study on Macular Edema Secondary to Branch Retinal Vein Occlusion by Intravitreal Ranibizumab with and without Selective Retina Therapy
Abstract
:1. Introduction
2. Materials and Methods
2.1. Subjects
2.2. Inclusion and Exclusion Criteria
- (1)
- Loss of sight in one eye;
- (2)
- Optic media that are insufficiently transparent to acquire fundus images or obtain other imaging findings from the eye to be treated;
- (3)
- Presence of inflammatory intraocular disorders, including infectious disorders;
- (4)
- Intraocular surgery or laser treatment within 6 months;
- (5)
- Intravitreal injection within 3 months;
- (6)
- Presence of a comorbidity reducing the visual acuity of the eye to be treated or that may require medical or surgical treatment during the study period;
- (7)
- Ophthalmic impairment in the eye to be treated that would confuse interpretation of the effectiveness of treatment in the judgment of an investigator or subinvestigator;
- (8)
- Scarring or atrophy of the central fovea indicating that reduced visual acuity of the eye to be treated would not be recoverable;
- (9)
- Vitreous traction or epiretinal membrane in the eye to be treated, visible on biological optical microscopy or OCT, that would significantly affect central visual acuity in the judgment of an investigator or subinvestigator;
- (10)
- Neovascularization of the iris or vitreous hemorrhage in the eye to be treated;
- (11)
- History of hypersensitivity to any component of anti-VEGF drugs.
- (1)
- Inflammatory disease;
- (2)
- Bleeding tendency and anticoagulation therapy;
- (3)
- Presence or possibility of pregnancy;
- (4)
- Untreated hypertension and diabetes mellitus;
- (5)
- History of stroke (cerebral infarction, cerebral hemorrhage, etc.) or transient ischemic attack.
2.3. Treatment Strategy
2.4. SRT Method
2.5. Clinical Observations
2.6. Outcome Measures
2.7. Statistical Analysis
3. Results
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Characteristics | IVR + SRT | IVR + sham | p-Value |
---|---|---|---|
Number | 13 eyes | 11 eyes | |
Sex, male: female (cases) | 7: 6 | 4: 7 | 0.33 |
Age; mean (range) | 67 (50–85) | 72 (63–80) | 0.20 |
Hypertension (%) | 9 (69) | 9 (82) | 0.41 |
Diabetes mellitus (%) | 3 (23) | 1 (9) | 0.36 |
Hyperlipidemia (%) | 2 (15) | 3 (27) | 0.41 |
Smoking (%) | 3 (23) | 6 (55) | 0.12 |
Intraocular lens (%) | 1 (8) | 2 (18) | 0.43 |
Previous treatment (%) | 6 (46) | 5 (45) | 0.50 |
BCVA (logMAR); mean (SD) | 0.28 (0.14) | 0.32 (0.31) | 0.93 |
CMT; mean (SD) | 536 (93) | 479 (138) | 0.24 |
Number of Treatments | IVR + SRT | IVR + sham | p-Value |
---|---|---|---|
IVR | |||
Week 0–13; Mean (SD) | 1.62 (0.65) | 1.82 (0.75) | 0.50 |
Week 14–52; Mean (SD) | 1.23 (1.24) | 2.91 (1.87) | <0.05 |
Week 0–52; Mean (SD) | 2.85 (1.52) | 4.73 (2.33) | <0.05 |
SRT (or sham SRT) | |||
Week 0–52; Mean (SD) | 2.15 (1.14) | 2.91 (0.94) | - |
Author /Year | Study Design | Follow-Up | Laser Devise/Method | Findings |
---|---|---|---|---|
BVOS group, 2018 [3] | Prospective, randomized; treated or untreated control group. VA: 20/40 or worse. | 3 years | Argon laser PC | Significant VA improvement in treated group. VA: 20/70 vs. 20/40–20/50. Number of lines gained: 0.23 vs. 1.33. |
Tadayoni R et al., 2017 [30] | Prospective, randomized; IVR alone, IVR + PC, PC alone groups. VA: 19 to 73 letters. | 2 years | Conventional PC (No laser details.) | No significant difference between IVR and IVR + PC groups. VA change: 15.0 vs. 15.4 letters. Number of injections: 11.4 vs. 11.3. |
Song S et al., 2020 [31] | Prospective, randomized; IVR or IVR + PC group. VA: 24 to 73 letters. | 1 year | Grid laser photocoagulation (No laser details.) | No significant difference between IVR and IVR + PC groups. VA change: 17.9 vs. 18.1 letters. Number of injections: 4 vs. 6. |
Murata T et al., 2021 [32] | Prospective, randomized; IVR or IVR + PC group. VA: 19 to 73 letters. | 1 year | Focal or grid short-pulse laser (Based on the ETDRS guidelines) | No significant difference between IVR and IVR + PC groups. VA change: 17.9 vs. 18.1 letters. Number of injections: 4 vs. 6. |
Buyru Ozkurt Y et al., 2018 [33] | Retrospective, non-randomized; IVR or SML group. VA: 1 to 0.22 (logMAR) | 1 year | Subthreshold micropulse laser (577 nm) | No significant difference between IVR and SML groups. VA: 0.57 to 0.34 vs. 0.50 to 0.33. |
Terashima H et al., 2019 [34] | Retrospective, non-randomized; IVR or IVR + SML group. VA: 20/400 to 20/25 | 6 months | Subthreshold micropulse laser (577 nm) | Significantly less number of injections for IVR + SML group. Number of injections: 2.3 ± 0.9 vs. 1.9 ± 0.8. No significant VA improvement between IVR and IVR + SML groups. VA: 0.11 ± 0.15 vs. 0.23 ± 0.38. |
The current study | Prospective, randomized; IVR or IVR + SRT group. VA: 0.7 to −0.08 (logMAR) | 1 year | SRT (527 nm, 1.7 µs, 100 Hz) |
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Yamamoto, M.; Miura, Y.; Hirayama, K.; Kyo, A.; Kohno, T.; Theisen-Kunde, D.; Brinkmann, R.; Honda, S. Comparative Treatment Study on Macular Edema Secondary to Branch Retinal Vein Occlusion by Intravitreal Ranibizumab with and without Selective Retina Therapy. Life 2023, 13, 769. https://doi.org/10.3390/life13030769
Yamamoto M, Miura Y, Hirayama K, Kyo A, Kohno T, Theisen-Kunde D, Brinkmann R, Honda S. Comparative Treatment Study on Macular Edema Secondary to Branch Retinal Vein Occlusion by Intravitreal Ranibizumab with and without Selective Retina Therapy. Life. 2023; 13(3):769. https://doi.org/10.3390/life13030769
Chicago/Turabian StyleYamamoto, Manabu, Yoko Miura, Kumiko Hirayama, Akika Kyo, Takeya Kohno, Dirk Theisen-Kunde, Ralf Brinkmann, and Shigeru Honda. 2023. "Comparative Treatment Study on Macular Edema Secondary to Branch Retinal Vein Occlusion by Intravitreal Ranibizumab with and without Selective Retina Therapy" Life 13, no. 3: 769. https://doi.org/10.3390/life13030769