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

Posterior Capsule Opacification Clinical Trial

Official title:

Retro- and Prospective Monocentric Study to Evaluate the Rate of Posterior Capsule Opacification Following Cataract Surgery With Implantation of the MICS (Micro Incision Cataract Surgery) -IOL (Intraocular Lens) L313

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03184428
• Other study ID #: STN 05/15
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: December 10, 2018

Study information

• Verified date: April 2020
• Source: Dietrich-Bonhoeffer-Klinikum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This study is a postmarket study without interventions. Within the Standard Care Cataract surgery the participants have been implanted with the intraocular lens L313 in the period between September 2009 and December 2013. As criterium for the PCO was considered the Nd:YAG capsulotomy.

In the first step of the study, data was collected from the patients´charts.

In the second phase, a questionaire was sent to the patients with no recent examination, asking them to answer whether or not participants received a laser procedure due to PCO. In doubt the participants could answer: "I am not certain". For this step the investigator ensured the positive Votum of the Ethic Committee of the University of Greifswald, Germany.

On the third step of the study, the patients that were not certain of having such a laser procedure or did not answer per post, will be contacted on telephone. By uncertainty or no answer on the telephone the family eye doctor will be contacted to receive the necessary information. If the eye doctor has lost contact to the patient, then this patient will be documented as lost-to-follow-up.

Excluded were the patients that live >50km from the Department of Ophthalmology in Neubrandenburg, as well as patients with intraoperative capsule tear.

For the statistical analysis was used the program STATISTICA (StatSoft, Hamburg, Germany) and the survival analysis using the Kaplan-Meier formula, the statistical significance using the Chi-squared test and Spearman-Rank corelation and the Bonferroni adjustment if the test was repeated.

The investigators compared these results with the results of other publication. In order to do that the investigators calculated the capsulotomy quote from this study according to the time of the PCO recorded on the other studies. Included were only comparing studies that also used YAG-capsulotomy as criterium for the PCO.

Furthermore secondary data was collected: age, gender, cutting length, core hardness, duration of whole operation, time of phaco-emulsification, phaco-energy, phaco-machine, combination with other operation, surgeon, power of IOL. This data will be taken in concern for the validity of this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3785
• Est. completion date: December 10, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• retrospective: Patients who have undergone a Cataract surgery with Implantation of IOL L313

• prospective: signed informed consent

Exclusion Criteria:

• capsule rupture

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

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Posterior Capsule Opacification

Intervention

Other:
• Postoperative observation and survey
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.

Locations

Country	Name	City	State
Germany	Dietrich-Bonhoeffer-Klinikum	Neubrandenburg	Mecklenburg/Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
Dietrich-Bonhoeffer-Klinikum

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Chitkara DK, Smerdon DL. Risk factors, complications, and results in extracapsular cataract extraction. J Cataract Refract Surg. 1997 May;23(4):570-4. — View Citation

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. — View Citation

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. Review. German. — View Citation

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. Review. German. — View Citation

Mester U, Fabian E, Gerl R, Hunold W, Hütz 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. German. — View Citation

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. — View Citation

Spyridaki M, Höh 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. — View Citation

Tetz MR, Nimsgern C. Posterior capsule opacification. Part 2: Clinical findings. J Cataract Refract Surg. 1999 Dec;25(12):1662-74. Review. — View Citation

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. German. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation Coefficient Between Capsulotomy Rate and Parameters	Correlation coefficients between capsulotomy rate and patient parameters: age; gender,; and surgical parameters: cutting length,; core hardness,; duration of whole operation,; time of phaco-emulsification,; phaco-energy,; phaco-machine,; combination with other operation,; surgeon,; power of IOL.	up to 8 years