Posterior Capsule Opacification Following Cataract Surgery With Implantation of the MICS IOL L313

NCT03184428 | Completed Results

• 1 other identifier: STN 05/15
• Study Type: observational
• Target: 3,785
• Locations: 1 country
• Sites: 1

Brief Summary

This study collects intra- and postoperative data from the patients´charts retrospectively and evaluates retro- and prospectively the rate of posterior capsule opacification (PCO) following implantation of the intraocular lens L 313.

Conditions

Posterior Capsule Opacification

Keywords

YAG-Laser Capsulotomy

Outcome Measures

Primary Outcomes (1)

• Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years

  In order to find out whether patients with cataract surgery are affected by lens opacification, we assessed whether a Nd:YAG laser capsulotomy was performed for treatment. For this purpose, the patient files were spotted first. Those who had no recent findings were asked in writing if and when a laser treatment was performed. In the absence of feedback and in case of uncertain or unusable written answer, a telephone consultation with the patient was made. If sufficient information was not available afterwards, the ophthalmologist was asked for information (by phone, by written request or by collecting the data on site in the practices).

  up to 8 years

Secondary Outcomes (1)

• Correlation Coefficient Between Capsulotomy Rate and Parameters

  up to 8 years

Study Arms (1)

Implantation of IOL L313

Patients who have undergone a cataract surgery with implantation of the monofocal MICS IOL L313 more than 3 Years ago will be asked about the Treatment for Postoperative observation and survey.

Other: Postoperative observation and survey

Interventions

Postoperative observation and survey OTHER

For postoperative Observation with a survey we ask the patients (or in case of no information the ophthalmologist) whether they had undergone a YAG-Laser-Capsulotomy after Cataract-Surgery or not.

Implantation of IOL L313

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

3785 (5549 eyes)

You may qualify if:

• retrospective: Patients who have undergone a Cataract surgery with Implantation of IOL L313
• prospective: signed informed consent

You may not qualify if:

• capsule rupture
• patients with too much travel distance between study center and home

Sponsors & Collaborators

• Dietrich-Bonhoeffer-Klinikum: lead

Study Sites (1)

Dietrich-Bonhoeffer-Klinikum

Neubrandenburg, Mecklenburg-Vorpommern, 17036, Germany

Location

Related Publications (17)

• Apple DJ, Peng Q, Visessook N, Werner L, Pandey SK, Escobar-Gomez M, Ram J, Auffarth GU. Eradication of posterior capsule opacification: documentation of a marked decrease in Nd:YAG laser posterior capsulotomy rates noted in an analysis of 5416 pseudophakic human eyes obtained postmortem. Ophthalmology. 2001 Mar;108(3):505-18. doi: 10.1016/s0161-6420(00)00589-3.

  PMID: 11237905 BACKGROUND

• Apple DJ, Peng Q, Visessook N, Werner L, Pandey SK, Escobar-Gomez M, Ram J, Whiteside SB, Schoderbeck R, Ready EL, Guindi A. Surgical prevention of posterior capsule opacification. Part 1: Progress in eliminating this complication of cataract surgery. J Cataract Refract Surg. 2000 Feb;26(2):180-7. doi: 10.1016/s0886-3350(99)00353-3.

  PMID: 10683785 BACKGROUND

• Auffarth GU, Brezin A, Caporossi A, Lafuma A, Mendicute J, Berdeaux G, Smith AF; European PCO Study Group. Comparison of Nd : YAG capsulotomy rates following phacoemulsification with implantation of PMMA, silicone, or acrylic intra-ocular lenses in four European countries. Ophthalmic Epidemiol. 2004 Oct;11(4):319-29. doi: 10.1080/09286580490515116.

  PMID: 15512993 BACKGROUND

• Chitkara DK, Smerdon DL. Risk factors, complications, and results in extracapsular cataract extraction. J Cataract Refract Surg. 1997 May;23(4):570-4. doi: 10.1016/s0886-3350(97)80216-7.

  PMID: 9209994 BACKGROUND

• Meacock WR, Spalton DJ, Boyce JF, Jose RM. Effect of optic size on posterior capsule opacification: 5.5 mm versus 6.0 mm AcrySof intraocular lenses. J Cataract Refract Surg. 2001 Aug;27(8):1194-8. doi: 10.1016/s0886-3350(01)00855-0.

  PMID: 11524189 BACKGROUND

• Menapace R. [After-cataract following intraocular lens implantation. Part II: prevention with alternative implants and techniques]. Ophthalmologe. 2007 Apr;104(4):345-53; quiz 354-5. doi: 10.1007/s00347-007-1505-1. German.

  PMID: 17372739 BACKGROUND

• Menapace R. [After-cataract following intraocular lens implantation. Part I. Genesis and prevention by optimizing conventional lens implants and surgical techniques]. Ophthalmologe. 2007 Mar;104(3):253-62; quiz 263-4. doi: 10.1007/s00347-007-1492-2. German.

  PMID: 17323043 BACKGROUND

• Mester U, Fabian E, Gerl R, Hunold W, Hutz W, Strobel J, Hoyer H, Kohnen T. Posterior capsule opacification after implantation of CeeOn Edge 911A, PhacoFlex SI-40NB, and AcrySof MA60BM lenses: one-year results of an intraindividual comparison multicenter study. J Cataract Refract Surg. 2004 May;30(5):978-85. doi: 10.1016/j.jcrs.2003.09.052.

  PMID: 15130632 BACKGROUND

• Nishi Y, Ikeda T, Nishi K, Mimura O. Epidemiological evaluation of YAG capsulotomy incidence for posterior capsule opacification in various intraocular lenses in Japanese eyes. Clin Ophthalmol. 2015 Sep 1;9:1613-7. doi: 10.2147/OPTH.S89966. eCollection 2015.

  PMID: 26366054 BACKGROUND

• Pandey SK, Apple DJ, Werner L, Maloof AJ, Milverton EJ. Posterior capsule opacification: a review of the aetiopathogenesis, experimental and clinical studies and factors for prevention. Indian J Ophthalmol. 2004 Jun;52(2):99-112.

  PMID: 15283214 BACKGROUND

• Prosdocimo G, Tassinari G, Sala M, Di Biase A, Toschi PG, Gismondi M, Corbanese U. Posterior capsule opacification after phacoemulsification: silicone CeeOn Edge versus acrylate AcrySof intraocular lens. J Cataract Refract Surg. 2003 Aug;29(8):1551-5. doi: 10.1016/s0886-3350(02)02051-5.

  PMID: 12954304 BACKGROUND

• Schaumberg DA, Dana MR, Christen WG, Glynn RJ. A systematic overview of the incidence of posterior capsule opacification. Ophthalmology. 1998 Jul;105(7):1213-21. doi: 10.1016/S0161-6420(98)97023-3.

  PMID: 9663224 BACKGROUND

• Schmidbauer JM, Vargas LG, Apple DJ, Auffarth GU, Peng Q, Arthur SN, Escobar-Gomez M. [Millenniums update on posterior capsule opacification (PCO) scores, centration, biocompatibility and fixation of foldable intraocular lenses (IOL) - an analysis of 1,221 pseudophakic post mortem globes]. Klin Monbl Augenheilkd. 2001 Oct;218(10):649-57. doi: 10.1055/s-2001-18386. German.

  PMID: 11706380 BACKGROUND

• Schriefl SM, Leydolt C, Stifter E, Menapace R. Posterior capsular opacification and Nd:YAG capsulotomy rates with the iMics Y-60H and Micro AY intra-ocular lenses: 3-year results of a randomized clinical trial. Acta Ophthalmol. 2015 Jun;93(4):342-7. doi: 10.1111/aos.12543. Epub 2014 Nov 13.

  PMID: 25393894 BACKGROUND

• Spyridaki M, Hoh H. [Comparison of four MICS intraocular lenses regarding their rates of neodymium:YAG laser capsulotomy]. Klin Monbl Augenheilkd. 2010 Mar;227(3):208-14. doi: 10.1055/s-0028-1109853. Epub 2010 Mar 16. German.

  PMID: 20234985 BACKGROUND

• Tetz MR, Nimsgern C. Posterior capsule opacification. Part 2: Clinical findings. J Cataract Refract Surg. 1999 Dec;25(12):1662-74. doi: 10.1016/s0886-3350(99)00259-x.

  PMID: 10609214 BACKGROUND

• Wehner W. [Microincision intraocular lens with plate haptic design. Evaluation of rotational stability and centering of a microincision intraocular lens with plate haptic design in 12-19 months of follow-up]. Ophthalmologe. 2007 May;104(5):393-4, 396-8. doi: 10.1007/s00347-007-1500-6. German.

  PMID: 17384950 BACKGROUND

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Christoforos Stylianides
• Organization: Eyestylianides ophthalmology center

Info@eyestylianides.com

0035725320244

Study Officials

• Helmut Hoeh, Prof. Dr.

  Department of Ophthalmology, Neubrandenburg, Germany

  PRINCIPAL INVESTIGATOR

• Christoforos Stylianides

  Department of Ophthalmology, Neubrandenburg, Germany

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 12, 2017
• Study Start: October 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: December 10, 2018
• Last Updated: April 29, 2020
• Results First Posted: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)