Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). This disease could lead to retinal detachment and blindness. ROP was traditionally treated with laser, but injection with a medication (A-VEGF) has become more common.
In this study, the researchers will explore whether treatment of ROP affects visual function and retinal development. To explore this, the study group will examine children with ROP (but not treated) with children treated with either laser or injection. The researchers will compare the children's visual functions (e.g. visual acuity and visual field) and their retinas (e.g. central and peripheral retina).
Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). The risk of ROP increases with lower gestational age and birth weight of the child. In a child born pre-term the blood vessels in the retina may not be fully developed. New - but unstructured - vessels could grow up from the retina and lead to retinal detachment and blindness. ROP was traditionally treated with laser, but injection with a medication (A-VEGF) into the eye has become more common.
In this study, the researchers aim to explore whether treatment of ROP affects visual function and retinal development. To investigate this, the study group will examine children with ROP (but not treated) with children treated with either laser or injection. The researchers will compare the children's visual functions (e.g. visual acuity and visual field) and their retinas (e.g. central and peripheral retina).
The participants will undergo a comprehensive eye examination, including imaging of the retina, visual field testing, and biometric measurements. Their parents will also answer questions regarding cerebral visual impairment.
Results from the group not treated for ROP will be compared to the treated subjects. Data will also be correlated with non-ocular parameters, such at gestational age, birth weight and brain hemorrhages.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser treated | Subjects treated for ROP with laser of avascular retina | ||
| Control laser treated | Control subjects matched with subjects treated with laser | ||
| A-VEGF treated | Subjects treated for ROP with intravitreal injection of A-VEGF | ||
| Control A-VEGF treated | Control subjects matched with subjects treated with A-VEGF |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Width of the foveal avascular zone | Width of the foveal avascular zone in micrometers measured with optical coherence tomography angiography | From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years |
| Choroidal vascularity | Choroidal vascularity in the macula measured with optical coherence tomography and with choroidal vascularity index in percent | From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years. |
| Retinal nerve fiber layer thickness | Retinal nerve fiber layer thickness in micrometers measured with optical coherence tomography | From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years. |
| Length of persistent avascular retina | Length of persistent avascular retina measured in millimeters using scanning laser ophthalmoscopy and fluorescein angiography | From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years. |
| Width of the visual field | Width of the visual field in degrees measured with Goldmann Perimetry | From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between cerebral visual impairment and brain hemorrhages | Correlation between scores for cerebral visual impairment at time of the study and brain hemorrhages in neonatal period | Neonatal period to time for data collection in the current study |
| Visual acuity |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erlend Christoffer Sommer Landsend, M.D., Ph.D. | Contact | 0047 91 50 27 70 | erllan@ous-hf.no | |
| Amanda Schjetlein, M.D. | Contact | 0047 91 50 27 70 | amasch@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Erlend Christoffer Sommer Landsend, M.D., Ph.D. | Oslo University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32059986 | Background | Hamad AE, Moinuddin O, Blair MP, Schechet SA, Shapiro MJ, Quiram PA, Mammo DA, Berrocal AM, Prakhunhungsit S, Cernichiaro-Espinosa LA, Mukai S, Yonekawa Y, Ung C, Holz ER, Harper CA 3rd, Young RC, Besirli CG, Nagiel A, Lee TC, Gupta MP, Walsh MK, Khawly JA, Campbell JP, Kychenthal A, Nudleman ED, Robinson JE, Hartnett ME, Calvo CM, Chang EY. Late-Onset Retinal Findings and Complications in Untreated Retinopathy of Prematurity. Ophthalmol Retina. 2020 Jun;4(6):602-612. doi: 10.1016/j.oret.2019.12.015. Epub 2019 Dec 24. | |
| 36201755 |
Not provided
Not provided
Awaits allowance to share IPD from the Regional committees for medical and health research ethics.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| D019575 | Blindness, Cortical |
| D012030 | Refractive Errors |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Visual acuity measured with LogMAR. |
| From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years. |
| Background |
| Lai TT, Yang CM, Hsieh YT, Yeh PT, Huang CW, Tsai CY. RATE OF AND TIME TO COMPLETE RETINAL VASCULARIZATION IN PREMATURE INFANTS AND ASSOCIATED FACTORS. Retina. 2023 Jan 1;43(1):102-110. doi: 10.1097/IAE.0000000000003627. |
| 34851464 | Background | Sternfeld A, Rahmani S, Rossen JL, Zhang DL, Li YD, Quan VL, Huang R, Yoon HH. Long-term retinal vasculature abnormalities following intravitreal bevacizumab for retinopathy of prematurity. Graefes Arch Clin Exp Ophthalmol. 2022 Jun;260(6):1915-1921. doi: 10.1007/s00417-021-05499-0. Epub 2021 Dec 1. |
| 37113473 | Background | Ling XC, Kang EY, Huang JL, Chou HD, Liu L, Lai CC, Chen KJ, Hwang YS, Wu WC. Persistent Vascular Anomalies in Retinopathy of Prematurity Children: Ultrawide-field Fluorescein Angiography Findings until School Age. Ophthalmol Sci. 2023 Feb 7;3(3):100281. doi: 10.1016/j.xops.2023.100281. eCollection 2023 Sep. |
| 17065917 | Background | Edmond JC, Foroozan R. Cortical visual impairment in children. Curr Opin Ophthalmol. 2006 Dec;17(6):509-12. doi: 10.1097/ICU.0b013e3280107bc5. |
| 37674073 | Background | Obata S, Matsumoto R, Iwasa M, Kakinoki M, Sawada O, Sawada T, Saishin Y, Ohji M. Visual field after anti-vascular endothelial growth factor therapy and laser treatment for retinopathy of prematurity. Graefes Arch Clin Exp Ophthalmol. 2023 Nov;261(11):3207-3213. doi: 10.1007/s00417-023-06227-6. Epub 2023 Sep 6. |
| 17542439 | Background | McLoone E, O'Keefe M, McLoone S, Lanigan B. Effect of diode laser retinal ablative therapy for threshold retinopathy of prematurity on the visual field: results of goldmann perimetry at a mean age of 11 years. J Pediatr Ophthalmol Strabismus. 2007 May-Jun;44(3):170-3. doi: 10.3928/0191-3913-20070301-10. |
| 11483077 | Background | Cryotherapy for Retinopathy of Prematurity Cooperative Group. Effect of retinal ablative therapy for threshold retinopathy of prematurity: results of Goldmann perimetry at the age of 10 years. Arch Ophthalmol. 2001 Aug;119(8):1120-5. doi: 10.1001/archopht.119.8.1120. |
| 8841302 | Background | Quinn GE, Dobson V, Hardy RJ, Tung B, Phelps DL, Palmer EA. Visual fields measured with double-arc perimetry in eyes with threshold retinopathy of prematurity from the cryotherapy for retinopathy of prematurity trial. The CRYO-Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1996 Sep;103(9):1432-7. doi: 10.1016/s0161-6420(96)30487-9. |
| 34168272 | Background | Ingvaldsen SH, Morken TS, Austeng D, Dammann O. Visuopathy of prematurity: is retinopathy just the tip of the iceberg? Pediatr Res. 2022 Apr;91(5):1043-1048. doi: 10.1038/s41390-021-01625-0. Epub 2021 Jun 24. |
| 37172142 | Background | Kulmala M, Jorgensen APM, Aakvik KAD, Jussinniemi L, Benum SD, Ingvaldsen SH, Austeng D, Kajantie E, Evensen KAI, Majander A, Morken TS. Visual function in adults born preterm with very low birth weight-A two-country birth cohort study. Acta Ophthalmol. 2024 Feb;102(1):49-57. doi: 10.1111/aos.15683. Epub 2023 May 12. |
| 30092239 | Background | Balasubramanian S, Beckmann J, Mehta H, Sadda SR, Chanwimol K, Nassisi M, Tsui I, Marlow N, Jain S. Relationship between Retinal Thickness Profiles and Visual Outcomes in Young Adults Born Extremely Preterm: The EPICure@19 Study. Ophthalmology. 2019 Jan;126(1):107-112. doi: 10.1016/j.ophtha.2018.07.030. Epub 2018 Aug 6. |
| 39376685 | Background | Najjaran M, Zarei-Ghanavati S, Ostadimoghaddam H, Yekta A, Shoeibi N, Hemmati A, Abrishami M, Akhlaghi S, Ziaei M. Ocular Biometric and Optical Coherence Tomography Parameters in Former Preterm Children: A Cohort Study. J Ophthalmol. 2024 Sep 30;2024:2381582. doi: 10.1155/2024/2381582. eCollection 2024. |
| 33387107 | Background | Acar DE, Acar U, Tunay ZO, Arman A, Goksuluk D. Retinal choroidal and retinal nerve fiber layer thickness in former preterm and full-term infants aged 4 to 8 years. Int Ophthalmol. 2021 Mar;41(3):1071-1079. doi: 10.1007/s10792-020-01666-0. Epub 2021 Jan 2. |
| 22569283 | Background | Akerblom H, Holmstrom G, Eriksson U, Larsson E. Retinal nerve fibre layer thickness in school-aged prematurely-born children compared to children born at term. Br J Ophthalmol. 2012 Jul;96(7):956-60. doi: 10.1136/bjophthalmol-2011-301010. Epub 2012 May 8. |
| 35258558 | Background | Kumarakulasinghe ALB, Md Din N, Mohd Noh UK, Syed Zakaria SZ, Aung T, Mohd Khialdin S. Evaluation of Ocular Biometric and Optical Coherence Tomography Parameters in Preterm Children Without Retinopathy of Prematurity. Transl Vis Sci Technol. 2022 Mar 2;11(3):8. doi: 10.1167/tvst.11.3.8. |
| 37996045 | Background | Oruz O, Dervisogullari MS. Comparison of choroidal structural changes between term and preterm children with and without retinopathy of prematurity. Photodiagnosis Photodyn Ther. 2024 Feb;45:103901. doi: 10.1016/j.pdpdt.2023.103901. Epub 2023 Nov 22. |
| 26868048 | Background | Agrawal R, Gupta P, Tan KA, Cheung CM, Wong TY, Cheng CY. Choroidal vascularity index as a measure of vascular status of the choroid: Measurements in healthy eyes from a population-based study. Sci Rep. 2016 Feb 12;6:21090. doi: 10.1038/srep21090. |
| 25277303 | Background | Anderson MF, Ramasamy B, Lythgoe DT, Clark D. Choroidal thickness in regressed retinopathy of prematurity. Eye (Lond). 2014 Dec;28(12):1461-8. doi: 10.1038/eye.2014.207. Epub 2014 Oct 3. |
| 32634443 | Background | Prousali E, Dastiridou A, Ziakas N, Androudi S, Mataftsi A. Choroidal thickness and ocular growth in childhood. Surv Ophthalmol. 2021 Mar-Apr;66(2):261-275. doi: 10.1016/j.survophthal.2020.06.008. Epub 2020 Jul 4. |
| 21546530 | Background | Shao Z, Dorfman AL, Seshadri S, Djavari M, Kermorvant-Duchemin E, Sennlaub F, Blais M, Polosa A, Varma DR, Joyal JS, Lachapelle P, Hardy P, Sitaras N, Picard E, Mancini J, Sapieha P, Chemtob S. Choroidal involution is a key component of oxygen-induced retinopathy. Invest Ophthalmol Vis Sci. 2011 Aug 5;52(9):6238-48. doi: 10.1167/iovs.10-6742. |
| 35268428 | Background | Czeszyk A, Hautz W, Jaworski M, Bulsiewicz D, Czech-Kowalska J. Morphology and Vessel Density of the Macula in Preterm Children Using Optical Coherence Tomography Angiography. J Clin Med. 2022 Feb 28;11(5):1337. doi: 10.3390/jcm11051337. |
| 32051137 | Background | Zhao J, Wu Z, Lam W, Yang M, Chen L, Zheng L, Zhang F, Zeng J, Wang J, Zhang G. Comparison of OCT angiography in children with a history of intravitreal injection of ranibizumab versus laser photocoagulation for retinopathy of prematurity. Br J Ophthalmol. 2020 Nov;104(11):1556-1560. doi: 10.1136/bjophthalmol-2019-315520. Epub 2020 Feb 12. |
| 33689582 | Background | Jabroun MN, AlWattar BK, Fulton AB. Optical Coherence Tomography Angiography in Prematurity. Semin Ophthalmol. 2021 May 19;36(4):264-269. doi: 10.1080/08820538.2021.1893760. Epub 2021 Mar 9. |
| 37393251 | Background | Ingvaldsen SH, Moljord K, Grotting A, Omland PM, Dammann O, Austeng D, Morken TS. Retinal structure and visual pathway function at school age in children born extremely preterm: a population-based study. BMC Ophthalmol. 2023 Jul 1;23(1):296. doi: 10.1186/s12886-023-03055-4. |
| 31047230 | Background | Bowl W, Bowl M, Schweinfurth S, Holve K, Knobloch R, Stieger K, Andrassi-Darida M, Lorenz B. OCT Angiography in Young Children with a History of Retinopathy of Prematurity. Ophthalmol Retina. 2018 Sep;2(9):972-978. doi: 10.1016/j.oret.2018.02.004. Epub 2018 Jul 20. |
| 26658507 | Background | Balaratnasingam C, Chae B, Remmer MH, Gomez E, Suzuki M, Engelbert M, Spaide RF. The Spatial Profile of Macular Pigments Is Related to the Topological Characteristics of the Foveal Avascular Zone. Invest Ophthalmol Vis Sci. 2015 Dec;56(13):7859-65. doi: 10.1167/iovs.15-17532. |
| 18413520 | Background | Provis JM, Hendrickson AE. The foveal avascular region of developing human retina. Arch Ophthalmol. 2008 Apr;126(4):507-11. doi: 10.1001/archopht.126.4.507. |
| 33146830 | Background | Maleita D, Serras-Pereira R, Passos I, Elisa-Luis M, Alves M, Papoila AL, Brito C, Cunha JP, Tavares Ferreira J. Retinal structural changes in preterm children without retinopathy of prematurity. Graefes Arch Clin Exp Ophthalmol. 2021 Apr;259(4):1025-1033. doi: 10.1007/s00417-020-04986-0. Epub 2020 Nov 4. |
| 28439729 | Background | Fiess A, Janz J, Schuster AK, Kolb-Keerl R, Knuf M, Kirchhof B, Muether PS, Bauer J. Macular morphology in former preterm and full-term infants aged 4 to 10 years. Graefes Arch Clin Exp Ophthalmol. 2017 Jul;255(7):1433-1442. doi: 10.1007/s00417-017-3662-5. Epub 2017 Apr 25. |
| 36473425 | Result | Wendel K, Aas MF, Gunnarsdottir G, Rossholt ME, Bratlie M, Nordvik T, Landsend ECS, Fugelseth D, Domellof M, Pripp AH, Stiris T, Moltu SJ. Effect of arachidonic and docosahexaenoic acid supplementation on respiratory outcomes and neonatal morbidities in preterm infants. Clin Nutr. 2023 Jan;42(1):22-28. doi: 10.1016/j.clnu.2022.11.012. Epub 2022 Nov 17. |
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001766 | Blindness |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |