Trial Outcomes & Findings for Posterior Capsule Opacification Following Cataract Surgery With Implantation of the MICS IOL L313 (NCT NCT03184428)

NCT ID: NCT03184428

Last Updated: 2020-04-29

Results Overview

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).

• Recruitment status: COMPLETED
• Target enrollment: 3785 participants
• Primary outcome timeframe: up to 8 years
• Results posted on: 2020-04-29

Participant Flow

Eyes of patients who underwent a cataract surgery in the Department of Ophthalmology in Neubrandenburg between September 2009 and December 2013 and had an L313 MICS lens implanted.

The following reasons led to an exclusion of participants: * intraoperative posterior capsule rupture * Distance between place of residence and place of investigation >50 km * Exchange of the intraocular lens * Practice closure of the supervising ophthalmologist * no entry in any established doctor's medical system * no follow-up

Unit of analysis: eyes

Participant milestones

Measure	L313-Implantation Eyes of patients who underwent a cataract surgery in the Department of Ophthalmology in Neubrandenburg between September 2009 and December 2013 and had an L313 MICS lens.
Overall Study STARTED	3785 5549
Overall Study COMPLETED	2963 4388
Overall Study NOT COMPLETED	822 1161

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Implantation of IOL L313 n=5549 eyes 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. 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 Nd: YAG-Laser-Capsulotomy after Cataract-Surgery or not.
Age, Categorical <=18 years	2 eyes n=5549 eyes
Age, Categorical Between 18 and 65 years	886 eyes n=5549 eyes
Age, Categorical >=65 years	4661 eyes n=5549 eyes
Age, Continuous	73.75 years STANDARD_DEVIATION 9.06 • n=5549 eyes
Sex: Female, Male Female	3285 eyes n=5549 eyes
Sex: Female, Male Male	2264 eyes n=5549 eyes

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Implantation of IOL L313 Age<55 n=164 eyes Patients age\<55 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.	Implantation of IOL L313 Age≥55 n=4224 eyes Patients age≥55 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.	Capsulotomy Rate/Cutting Lenth Correlation coefficient between capsulotomy rate and cutting length	Capsulotomy Rate/Core Hardness Correlation coefficient between capsulotomy rate and core hardness	Capsulotomy Rate/Duration of Whole Operation Correlation coefficient between capsulotomy rate and duration of whole operation	Capsulotomy Rate/Time of Phaco-emulsification Correlation coefficient between capsulotomy rate and time of phaco-emulsification	Capsulotomy Rate/Phaco-energy Correlation coefficient between capsulotomy rate and phaco-energy	Capsulotomy Rate/Phaco-machine Correlation coefficient between capsulotomy rate and phaco-machine	Capsulotomy Rate/Combination With Other op Correlation coefficient between capsulotomy rate and L-313 implantation in combination with other op	Capsulotomy Rate/Surgeon Correlation coefficient between capsulotomy rate and surgeon	Correlation Rate/Power of IOL Correlation coefficient between capsulotomy rate and power of IOL
Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years 1 year	7.9 percentage of eyes	4.7 percentage of eyes	—	—	—	—	—	—	—	—	—
Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years 2 years	17.1 percentage of eyes	8.2 percentage of eyes	—	—	—	—	—	—	—	—	—
Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years after 4 years	25.0 percentage of eyes	17.2 percentage of eyes	—	—	—	—	—	—	—	—	—
Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years after 6 years	25.6 percentage of eyes	22.4 percentage of eyes	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 8 years

Correlation coefficients between capsulotomy rate and patient parameters:

1. age

2. gender,

and surgical parameters:

3. cutting length,

4. core hardness,

5. duration of whole operation,

6. time of phaco-emulsification,

7. phaco-energy,

8. phaco-machine,

9. combination with other operation,

10. surgeon,

11. power of IOL.

Outcome measures

Measure	Implantation of IOL L313 Age<55 n=4388 eyes Patients age\<55 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.	Implantation of IOL L313 Age≥55 n=4224 eyes Patients age≥55 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.	Capsulotomy Rate/Cutting Lenth n=4224 eyes Correlation coefficient between capsulotomy rate and cutting length	Capsulotomy Rate/Core Hardness n=3944 eyes Correlation coefficient between capsulotomy rate and core hardness	Capsulotomy Rate/Duration of Whole Operation n=4068 eyes Correlation coefficient between capsulotomy rate and duration of whole operation	Capsulotomy Rate/Time of Phaco-emulsification n=4088 eyes Correlation coefficient between capsulotomy rate and time of phaco-emulsification	Capsulotomy Rate/Phaco-energy n=3864 eyes Correlation coefficient between capsulotomy rate and phaco-energy	Capsulotomy Rate/Phaco-machine n=3906 eyes Correlation coefficient between capsulotomy rate and phaco-machine	Capsulotomy Rate/Combination With Other op n=4224 eyes Correlation coefficient between capsulotomy rate and L-313 implantation in combination with other op	Capsulotomy Rate/Surgeon n=4049 eyes Correlation coefficient between capsulotomy rate and surgeon	Correlation Rate/Power of IOL n=4224 eyes Correlation coefficient between capsulotomy rate and power of IOL
Correlation Coefficient Between Capsulotomy Rate and Parameters	0.0001 Correlation coefficient	0.276 Correlation coefficient	0.578 Correlation coefficient	0.041 Correlation coefficient	0.467 Correlation coefficient	0.739 Correlation coefficient	0.782 Correlation coefficient	0.746 Correlation coefficient	0.002 Correlation coefficient	0.727 Correlation coefficient	0.578 Correlation coefficient

Adverse Events

Implantation of IOL L313

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christoforos Stylianides

Eyestylianides ophthalmology center

Phone: 0035725320244

Email: Info@eyestylianides.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place