Trial Outcomes & Findings for Late Dislocation of Intraocular Lens (IOL) Following Cataract Surgery: an Evaluation of Two Different Surgical Methods (NCT NCT01784926)

Results Overview

Measure for visual function. Measured in logMAR

Recruitment status

UNKNOWN

Study phase

NA

Target enrollment

104 participants

Primary outcome timeframe

6 months, 1 year and 2 years

Results posted on

2019-09-27

Participant Flow

Altogether 175 patients were assessed for eligibility, 104 patients were enrolled.

Participant milestones

Participant milestones
Measure	IOL Repositioning Operation method: Intraocular lens repositioning by scleral suturing 54 patients were randomised to this group. 11 patients were lost to follow-up before the 6-month postoperative visit because of serious illness and 1 death (unrelated to the condition studied).	IOL Exchange Operation method: Intraocular lens exchange with retropupillary iris-claw lens 50 patients were randomised to this group. 8 patients were lost to follow-up before the 6-month postoperative visit because of serious illness (unrelated to the condition studied).
Overall Study STARTED	54	50
Overall Study COMPLETED	43	42
Overall Study NOT COMPLETED	11	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Late Dislocation of Intraocular Lens (IOL) Following Cataract Surgery: an Evaluation of Two Different Surgical Methods

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IOL Repositioning n=54 Participants Operation method: Intraocular lens repositioning by scleral suturing	IOL Exchange n=50 Participants Operation method: Intraocular lens exchange with retropupillary iris-claw lens	Total n=104 Participants Total of all reporting groups
Age, Continuous	81 years n=5 Participants	82 years n=7 Participants	81.5 years n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	29 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants	50 Participants n=7 Participants	104 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Norway	54 Participants n=5 Participants	50 Participants n=7 Participants	104 Participants n=5 Participants
Mean best-corrected visual acuity	0.37 logMAR STANDARD_DEVIATION 0.42 • n=5 Participants	0.64 logMAR STANDARD_DEVIATION 0.77 • n=7 Participants	0.50 logMAR STANDARD_DEVIATION 0.63 • n=5 Participants
Mean intraocular pressure	17.7 mmHg STANDARD_DEVIATION 5.0 • n=5 Participants	18.3 mmHg STANDARD_DEVIATION 7.2 • n=7 Participants	18.0 mmHg STANDARD_DEVIATION 6.2 • n=5 Participants
Mean time since cataract surgery	10.6 years STANDARD_DEVIATION 4.3 • n=5 Participants	10.0 years STANDARD_DEVIATION 4.3 • n=7 Participants	10.3 years STANDARD_DEVIATION 4.3 • n=5 Participants
Mean endothelial cell density	1940 cells/mm^2 STANDARD_DEVIATION 418 • n=5 Participants	1718 cells/mm^2 STANDARD_DEVIATION 449 • n=7 Participants	1839 cells/mm^2 STANDARD_DEVIATION 444 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months, 1 year and 2 years

Measure for visual function. Measured in logMAR

Outcome measures

Outcome measures
Measure	IOL Repositioning n=43 Participants Operation method: Intraocular lens repositioning by scleral suturing	IOL Exchange n=42 Participants Operation method: Intraocular lens exchange with retropupillary iris-claw lens
Best Corrected Visual Acuity (BCVA) BCVA 1 year	0.21 logMAR Standard Deviation 0.26	0.23 logMAR Standard Deviation 0.34
Best Corrected Visual Acuity (BCVA) BCVA 6 months	0.24 logMAR Standard Deviation 0.29	0.35 logMAR Standard Deviation 0.54
Best Corrected Visual Acuity (BCVA) BCVA 2 years	0.20 logMAR Standard Deviation 0.29	0.22 logMAR Standard Deviation 0.30

PRIMARY outcome

Timeframe: 6 months and 2 years

Measure for the pressure inside the eye, measured with Goldman applanation tonometer, in mmHg.

Outcome measures

Outcome measures
Measure	IOL Repositioning n=43 Participants Operation method: Intraocular lens repositioning by scleral suturing	IOL Exchange n=42 Participants Operation method: Intraocular lens exchange with retropupillary iris-claw lens
Intraocular Pressure (IOP) IOP 6 months	16.5 mmHg Standard Deviation 5.2	14.9 mmHg Standard Deviation 4.2
Intraocular Pressure (IOP) IOP 2 years	15.7 mmHg Standard Deviation 4.0	14.1 mmHg Standard Deviation 4.2

PRIMARY outcome

Timeframe: 6 months

Population: Some missing data due to inadequate corneal images

Corneal endothelial cell density (ECD), measured by confocal microscopy. Reported in cells per square millimeter

Outcome measures

Outcome measures
Measure	IOL Repositioning n=37 Participants Operation method: Intraocular lens repositioning by scleral suturing	IOL Exchange n=33 Participants Operation method: Intraocular lens exchange with retropupillary iris-claw lens
Endothelial Density	1858 cells/mm^2 Standard Deviation 433	1514 cells/mm^2 Standard Deviation 470

PRIMARY outcome

Timeframe: 6 months and 2 years

Population: Some loss to follow-up

Cystoid macular edema considered the most important long-term complication and therefore reported here.

Outcome measures

Outcome measures
Measure	IOL Repositioning n=43 Participants Operation method: Intraocular lens repositioning by scleral suturing	IOL Exchange n=42 Participants Operation method: Intraocular lens exchange with retropupillary iris-claw lens
Postoperative Complications CME 2 years · No cystoid macular edema	38 Participants	36 Participants
Postoperative Complications CME 6 months · Cystoid macular edema	3 Participants	4 Participants
Postoperative Complications CME 6 months · No cystoid macular edema	40 Participants	38 Participants
Postoperative Complications CME 2 years · Cystoid macular edema	5 Participants	6 Participants

SECONDARY outcome

Timeframe: 6 months (only analyzed/reported for this time frame)

Population: Some missing data due to poor image/measurement quality, overall number of participants therefore lower than the number of participants attending the 6-month visit

Keratometry of the cornea. Corneal astigmatism, measured in diopters.

Outcome measures

Outcome measures
Measure	IOL Repositioning n=40 Participants Operation method: Intraocular lens repositioning by scleral suturing	IOL Exchange n=39 Participants Operation method: Intraocular lens exchange with retropupillary iris-claw lens
Keratometry	1.2 Diopters Standard Deviation 1.0	1.2 Diopters Standard Deviation 0.8

SECONDARY outcome

Timeframe: 6 months (only analyzed/reported for this time frame)

Population: Some loss to follow-up

Questionnaire considering subjective visual function, scale 0-100 (higher scores mean better subjective visual outcome, lower scores means worse outcome).

Outcome measures

Outcome measures
Measure	IOL Repositioning n=43 Participants Operation method: Intraocular lens repositioning by scleral suturing	IOL Exchange n=42 Participants Operation method: Intraocular lens exchange with retropupillary iris-claw lens
Questionnaire Visual Function-14 (VF-14) Score	91.6 score points Standard Deviation 16.4	90.1 score points Standard Deviation 18.2

SECONDARY outcome

Timeframe: 2 years

Measure IOL's location with slit lamp and Pentacam.

Outcome measures

Outcome data not reported

Adverse Events

IOL Repositioning

Serious events: 10 serious events

Other events: 3 other events

Deaths: 1 deaths

IOL Exchange

Serious events: 8 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IOL Repositioning n=43 participants at risk；n=54 participants at risk Operation method: Intraocular lens repositioning by scleral suturing	IOL Exchange n=42 participants at risk；n=50 participants at risk Operation method: Intraocular lens exchange with retropupillary iris-claw lens
General disorders Serious illness	18.5% 10/54 • Number of events 10 • 6 months Adverse events were registered as specific perioperative and postoperative complications related to the surgery. Otherwise we registered the number of participants that were lost to-follow up due to serious illness (other conditions than the studied) or death.	16.0% 8/50 • Number of events 8 • 6 months Adverse events were registered as specific perioperative and postoperative complications related to the surgery. Otherwise we registered the number of participants that were lost to-follow up due to serious illness (other conditions than the studied) or death.

Other adverse events

Other adverse events
Measure	IOL Repositioning n=43 participants at risk；n=54 participants at risk Operation method: Intraocular lens repositioning by scleral suturing	IOL Exchange n=42 participants at risk；n=50 participants at risk Operation method: Intraocular lens exchange with retropupillary iris-claw lens
Eye disorders Cystoid macular edema	7.0% 3/43 • Number of events 3 • 6 months Adverse events were registered as specific perioperative and postoperative complications related to the surgery. Otherwise we registered the number of participants that were lost to-follow up due to serious illness (other conditions than the studied) or death.	9.5% 4/42 • Number of events 4 • 6 months Adverse events were registered as specific perioperative and postoperative complications related to the surgery. Otherwise we registered the number of participants that were lost to-follow up due to serious illness (other conditions than the studied) or death.

Additional Information

Dr. Olav Kristianslund

Oslo University Hospital

Phone: +4723015168

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place