Trial Outcomes & Findings for Clinical Evaluation of Morcher Artificial Iris Diaphragms (NCT NCT00812708)

NCT ID: NCT00812708

Last Updated: 2021-12-15

Results Overview

The primary efficacy measure of the study was the change in corrected distance visual acuity (CDVA) under glare conditions. A transilluminator light was held just in front of the distance corrected study eye in one of four quadrants (above, below, nasal, or temporal) to the line of sight to evoke a glare response. The direction that produced the worst CDVA was called the CDVA with glare. A ≥ 2 line improvement in Snellen CDVA with glare following Morcher device implantation was considered a positive clinical change (glare sensitivity better). A ≥ 2 line worsening of Snellen CDVA with glare following Morcher device implantation was considered a negative clinical change (glare sensitivity worse). A change of \< 2 Snellen lines following Morcher device implantation was considered to be a neutral change (glare sensitivity the same).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 72 participants
• Primary outcome timeframe: Preoperatively and 1 year postoperatively
• Results posted on: 2021-12-15

Participant Flow

Most patients were recruited from the principal investigator's ophthalmic practice. A few were referred by local ophthalmologists.

Participant milestones

Measure	Morcher Iris Diaphragm Study Group This group consists of all patients enrolled in the Morcher iris diaphragm study.
Overall Study STARTED	72
Overall Study Taken to Surgery for Device Implantation	66
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Morcher Iris Diaphragm Study Group This group consists of all patients enrolled in the Morcher iris diaphragm study.
Overall Study Device could not be implanted	2
Overall Study Lack of medical insurance	1
Overall Study Switched to another study	1
Overall Study Surgery cancelled due to uveitis	1
Overall Study Signed consent but later withdrew	3

Baseline Characteristics

Clinical Evaluation of Morcher Artificial Iris Diaphragms

Baseline characteristics by cohort

Measure	Morcher Iris Diaphragm Study Group n=72 Participants Seventy two patients signed consent forms to participate in the Morcher iris diaphragm study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants
Region of Enrollment United States	72 Participants n=5 Participants

PRIMARY outcome

Timeframe: Preoperatively and 1 year postoperatively

Population: This group consisted of all patients implanted with Morcher iris diaphragms.

The primary efficacy measure of the study was the change in corrected distance visual acuity (CDVA) under glare conditions. A transilluminator light was held just in front of the distance corrected study eye in one of four quadrants (above, below, nasal, or temporal) to the line of sight to evoke a glare response. The direction that produced the worst CDVA was called the CDVA with glare. A ≥ 2 line improvement in Snellen CDVA with glare following Morcher device implantation was considered a positive clinical change (glare sensitivity better). A ≥ 2 line worsening of Snellen CDVA with glare following Morcher device implantation was considered a negative clinical change (glare sensitivity worse). A change of < 2 Snellen lines following Morcher device implantation was considered to be a neutral change (glare sensitivity the same).

Outcome measures

Measure	Morcher Iris Diaphragm Implantation Group n=64 Participants All patients implanted with Morcher iris diaphragms.
Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure) Glare sensitivity worse	1 Participants
Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure) Glare sensitivity better	51 Participants
Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure) Glare sensitivity the same	12 Participants

PRIMARY outcome

Timeframe: Preoperatively and 1 year postoperatively

Population: This group consisted of all patients implanted with Morcher iris diaphragms.

The primary safety measure of the study was the change in best corrected distance visual acuity (CDVA) as measured using a Snellen eye chart. A ≥ 2 line improvement in Snellen CDVA following Morcher device implantation was considered a positive clinical change (visual acuity better). A ≥ 2 line worsening of Snellen CDVA following Morcher device implantation was considered a negative clinical change (visual acuity worse). A change of < 2 lines was considered to be a neutral change (visual acuity the same).

Outcome measures

Measure	Morcher Iris Diaphragm Implantation Group n=64 Participants All patients implanted with Morcher iris diaphragms.
Change in Best Corrected Visual Acuity (Primary Safety Measure) Visual acuity better	35 Participants
Change in Best Corrected Visual Acuity (Primary Safety Measure) Visual acuity the same	28 Participants
Change in Best Corrected Visual Acuity (Primary Safety Measure) Visual acuity worse	1 Participants

SECONDARY outcome

Timeframe: Preoperatively and 3 months postoperatively

Population: This group consisted of all patients implanted with Morcher iris diaphragms.

A secondary efficacy measure of the study was day time glare disability as assessed by subjective questionnaire. Glare disability was rated using a 0 to 10 scale, where 0 was considered very slight and 10 was considered very significant.

Outcome measures

Measure	Morcher Iris Diaphragm Implantation Group n=64 Participants All patients implanted with Morcher iris diaphragms.
Change in Glare Sensitivity Under Day Time Lighting Conditions (Secondary Efficacy Measure) Subjective day time glare sensitivity worse	2 Participants
Change in Glare Sensitivity Under Day Time Lighting Conditions (Secondary Efficacy Measure) Subjective day time glare sensitivity better	57 Participants
Change in Glare Sensitivity Under Day Time Lighting Conditions (Secondary Efficacy Measure) Subjective day time glare sensitivity the same	5 Participants

SECONDARY outcome

Timeframe: Preoperatively and 3 months postoperatively

Another secondary efficacy measure of the study was night time glare disability as assessed by subjective questionnaire. Glare disability was rated using a 0 to 10 scale, where 0 was considered very slight and 10 was considered very significant.

Outcome measures

Measure	Morcher Iris Diaphragm Implantation Group n=64 Participants All patients implanted with Morcher iris diaphragms.
Change in Glare Sensitivity Under Night Time Lighting Conditions (Secondary Efficacy Measure) Subjective night time glare sensitivity better	56 Participants
Change in Glare Sensitivity Under Night Time Lighting Conditions (Secondary Efficacy Measure) Subjective night time glare sensitivity the same	5 Participants
Change in Glare Sensitivity Under Night Time Lighting Conditions (Secondary Efficacy Measure) Subjective night time glare sensitivity worse	3 Participants

SECONDARY outcome

Timeframe: Preoperatively and 3 months postoperatively

Population: This group consisted of all patients implanted with Morcher iris diaphragms, for whom simultaneous corneal transplantation was not performed, and in whom endothelial cell counts could be obtained preoperatively and postoperatively.

A secondary safety measure of the study was the change in endothelial cell count. A loss of >10% of central corneal endothelial cells was considered clinically significant at the onset of the study. (Note, the 10% loss criterion was established before the 67B implant was added to the list of study devices. The 67B implant has an expected greater cell loss than that associated with the 96F, 96S, 50D, and 50F modified capsule tension rings because it requires a larger incision for implantation. Thirty one (48.4%) of the 64 patients were implanted with the 67B device.)

Outcome measures

Measure	Morcher Iris Diaphragm Implantation Group n=35 Participants All patients implanted with Morcher iris diaphragms.
Change in Endothelial Cell Count (Secondary Safety Measure) Endothelial cell loss > 10%	18 Participants
Change in Endothelial Cell Count (Secondary Safety Measure) Endothelial cell loss ≤ 10%	17 Participants

SECONDARY outcome

Timeframe: Preoperatively and 1 year postoperatively

Population: This group consisted of all patients implanted with Morcher iris diaphragms.

Another secondary safety measure of the study was the need to explant or exchange a Morcher iris diaphragm within 1 year of implantation. Explantation in < 25% of patients was considered to be clinically acceptable.

Outcome measures

Measure	Morcher Iris Diaphragm Implantation Group n=64 Participants All patients implanted with Morcher iris diaphragms.
Need to Explant or Exchange a Morcher Iris Diaphragm (Secondary Safety Measure) Morcher device explanted	1 Participants
Need to Explant or Exchange a Morcher Iris Diaphragm (Secondary Safety Measure) Morcher device not explanted	63 Participants

Adverse Events

Morcher Iris Diaphragm Implantation Group

Serious events: 6 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Morcher Iris Diaphragm Implantation Group n=64 participants at risk All patients implanted with Morcher iris diaphragms
Eye disorders Decentered piggyback intraocular lens	1.6% 1/64 • Number of events 1 • Adverse event data were collected for 1 year following Morcher iris diaphragm implantation. Adverse Event and Serious Adverse Event data were collected according to institutional review board (IRB) guidelines.
Eye disorders Retained lens fragment	1.6% 1/64 • Number of events 1 • Adverse event data were collected for 1 year following Morcher iris diaphragm implantation. Adverse Event and Serious Adverse Event data were collected according to institutional review board (IRB) guidelines.
Eye disorders Corneal failure	1.6% 1/64 • Number of events 1 • Adverse event data were collected for 1 year following Morcher iris diaphragm implantation. Adverse Event and Serious Adverse Event data were collected according to institutional review board (IRB) guidelines.
Eye disorders Corneal graft-host interface leak	1.6% 1/64 • Number of events 1 • Adverse event data were collected for 1 year following Morcher iris diaphragm implantation. Adverse Event and Serious Adverse Event data were collected according to institutional review board (IRB) guidelines.
Eye disorders Morcher iris diaphragm rotation	1.6% 1/64 • Number of events 1 • Adverse event data were collected for 1 year following Morcher iris diaphragm implantation. Adverse Event and Serious Adverse Event data were collected according to institutional review board (IRB) guidelines.
Eye disorders Retinal detachment	1.6% 1/64 • Number of events 1 • Adverse event data were collected for 1 year following Morcher iris diaphragm implantation. Adverse Event and Serious Adverse Event data were collected according to institutional review board (IRB) guidelines.

Other adverse events

Measure	Morcher Iris Diaphragm Implantation Group n=64 participants at risk All patients implanted with Morcher iris diaphragms
Eye disorders Intraoperative hyphema	1.6% 1/64 • Number of events 1 • Adverse event data were collected for 1 year following Morcher iris diaphragm implantation. Adverse Event and Serious Adverse Event data were collected according to institutional review board (IRB) guidelines.
Eye disorders Cystoid macular edema	1.6% 1/64 • Number of events 1 • Adverse event data were collected for 1 year following Morcher iris diaphragm implantation. Adverse Event and Serious Adverse Event data were collected according to institutional review board (IRB) guidelines.
Eye disorders Acute iritis	1.6% 1/64 • Number of events 1 • Adverse event data were collected for 1 year following Morcher iris diaphragm implantation. Adverse Event and Serious Adverse Event data were collected according to institutional review board (IRB) guidelines.
Eye disorders Ocular hypertension	3.1% 2/64 • Number of events 2 • Adverse event data were collected for 1 year following Morcher iris diaphragm implantation. Adverse Event and Serious Adverse Event data were collected according to institutional review board (IRB) guidelines.

Additional Information

Kevin M. Miller, MD

University of California Los Angeles

Phone: (310) 206-9951

Email: millerpatients@jsei.ucla.edu

Results disclosure agreements

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