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This prospective randomized controlled trial will be conducted to investigate Clareon intraocular lens (IOL) stability in vitrectomy patients. The investigator plans to target the patients undergoing cataract surgery. A randomized study will be conducted with 2 arms, one with Clareon IOL versus a second arm using the Tecnis 1 In this non-inferiority study, the investigator will compare Clareon IOL from Alcon with the existing Tecnis 1 IOL from Precision Lens which is the commonly used intraocular lens in combined vitrectomy cases in Hong Kong.
All patients will undergo standard phacoemulsification cataract extraction with Clareon IOL or Tecnis 1 IOL by an experienced cataract surgeon. Followed by vitrectomy to treat either, epiretinal membrane or vitreous hemorrhage.
All patients returned for follow-up visits at 1 week, 1 month, and 6 months after surgery for ophthalmic assessments including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon IOL from Alcon | Experimental | Monofocal artificial lens implanted in the eye following cataract surgery |
|
| Tecnis 1 from from Precision Lens | Active Comparator | Monofocal 1 piece IOL implanted in the eye following cataract surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon | Device | Monofocal intraocular lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Position stability of Clareon and Tecnis 1 IOL | Two arms will compare Intraocular lens stability, which will be measured by it's tilt, measures in degrees from iris plane (0, deg). Tilt will be measured using Pentacam by Sasaki method. | 1 week, 1 month and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | Visual acuity will be measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart | 1 week, 1 month and 6 months |
| Refraction | Refraction will be measured by an autorefractor, and the unit of measurement is Diopter. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Fung | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grantham Hospital | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26605364 | Background | Nagy ZZ, McAlinden C. Femtosecond laser cataract surgery. Eye Vis (Lond). 2015 Jun 30;2:11. doi: 10.1186/s40662-015-0021-7. eCollection 2015. | |
| 7530106 | Background | Korynta J, Bok J, Cendelin J. Changes in refraction induced by change in intraocular lens position. J Refract Corneal Surg. 1994 Sep-Oct;10(5):556-64. |
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By direct contact to the corresponding author or PI
5 years after the study ends
Case by case
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| ID | Term |
|---|---|
| D019773 | Epiretinal Membrane |
| D014823 | Vitreous Hemorrhage |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D005130 | Eye Hemorrhage |
| D006470 | Hemorrhage |
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Patients are randomised and masked from the treatment
| Tecnis 1 |
| Device |
Monofocal 1 Piece intraocular lens |
|
| 1 week, 1 month and 6 months |
| Axial movement | Axial movement will be measured by Pentacam (OCULUS Optikgeräte GmbH, Germany) using the Sasaki method. For axial movement unit of measurement is millimeter. | 1 week, 1 month and 6 months |
| Decentration | Decentration will be measured from the center of the IOL anterior surface to the pupillary axis, which will be perpendicular to the line between the two anterior chamber angles and through the midpoint of the line. The unit of measurement for decentration is millimeter. | 1 week, 1 month and 6 months |
| Compare intra operative and post operative complication | Any surgical complications and post operative complications will be documented. | 1 week, 1 month and 6 months |
| 16157803 | Background | Wang L, Koch DD. Effect of decentration of wavefront-corrected intraocular lenses on the higher-order aberrations of the eye. Arch Ophthalmol. 2005 Sep;123(9):1226-30. doi: 10.1001/archopht.123.9.1226. |
| 16539046 | Background | Rosales P, Marcos S. Phakometry and lens tilt and decentration using a custom-developed Purkinje imaging apparatus: validation and measurements. J Opt Soc Am A Opt Image Sci Vis. 2006 Mar;23(3):509-20. doi: 10.1364/josaa.23.000509. |
| 17321392 | Background | de Castro A, Rosales P, Marcos S. Tilt and decentration of intraocular lenses in vivo from Purkinje and Scheimpflug imaging. Validation study. J Cataract Refract Surg. 2007 Mar;33(3):418-29. doi: 10.1016/j.jcrs.2006.10.054. |
| 25788077 | Background | Dolgin E. The myopia boom. Nature. 2015 Mar 19;519(7543):276-8. doi: 10.1038/519276a. No abstract available. |
| 11918933 | Background | Schulz KF, Grimes DA. Unequal group sizes in randomised trials: guarding against guessing. Lancet. 2002 Mar 16;359(9310):966-70. doi: 10.1016/S0140-6736(02)08029-7. |
| 26545238 | Background | Pan CW, Liu H, Sun HP, Xu Y. Increased Difficulties in Managing Stairs in Visually Impaired Older Adults: A Community-Based Survey. PLoS One. 2015 Nov 6;10(11):e0142516. doi: 10.1371/journal.pone.0142516. eCollection 2015. |
| 30686704 | Background | Lane S, Collins S, Das KK, Maass S, Thatthamla I, Schatz H, Van Noy S, Jain R. Evaluation of intraocular lens mechanical stability. J Cataract Refract Surg. 2019 Apr;45(4):501-506. doi: 10.1016/j.jcrs.2018.10.043. Epub 2019 Jan 25. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |