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Extracts from the Manual of Procedures for the 1995-8 LIGHT-ROP clinical trial
by Drs. Reynolds, Spencer, et al.

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Authors will detect and remove any protection of babies

Study centers agreed to keep their nurseries overbright

The measurements omit the most damaging radiation

Authors measure useless averages instead of peaks
> Page 5 - 5 > continued 06-07-95

5.7 RATIONALE
FOR LIGHT MONITORING PROTOCOL

The light monitors represent a considerable expense. Therefore we have elected to monitor a portion of the control and treatment babies. We propose to continuously monitor five babies at each study center. This represents a sizeable percentage of our total enrollment at any given time.

Five individual babies at any one time will be monitored at each center. Both treatment and control babies will be monitored. All individuals will be assigned a randomization that will be disclosed only if there is a monitor available. Each monitored baby will keep the monitor by his side as he moves through the various nursery positions. When eye exams begin, that child's monitor will be available and assigned to one of the next few infants by the Coordinating Center at the time the treatment is assigned.

As infants are transferred from unit to unit or from position to position within a unit, the monitor will move with him. In this fashion light monitors will provide us with an awareness of our nursery ambient lighting conditions 24 hours a day.  We will be able to detect any unauthorized alteration in ambient lighting either by unit (e.g., turning out the lights) or by infant (e.g., isolette draping). This will help ensure a proper stratification of  > Page 5 - 5 > 06-07-95  lighting exposure between treatment and control infant. If the monitors reveal such_ tampering with ambient light we will move to correct this.

[Note : The authors want to expose the control infants to as much as possible of the radiation which they described as damaging, simply to increase the "stratification" contrast with the allegedly protected group. They never explained this to the parents but lied in the consent form.]

The Buffalo and Dallas centers are currently brightly illuminated nurseries. Our participating neonatologists have agreed to continue these standards throughout the study period. Ambient light monitors will help ensure compliance by the nursing staff. At study conclusion we will also have many individual tracings and be able to develop an average ambient lighting condition as an exposure reference point.

[Note: The neonatologists cited have thus agreed to deny the babies the customary protection which nurses and parents commonly give them from the unrelenting brightness. This is exactly the Tuskeegee protocol all over again.]

 

5.8 METHOD OF LIGHT MONITORING

The method of light monitoring to be used will consist of monitoring illuminance and irradiance of the ambieot nursery lighting with photodiodes. The light data is recorded in a light monitor, described below. Light monitoring will be performed in ail nursery units as the individual babies move through them. The photodiodes will be placed close to but not in contact with the babies' heads. Shielding bejween the infant's eye and light monitor will not be allowed.

5.9 LIGHT MONITORING DATALOGGER

A simple device, the light datalogger, has been developed to enable the amount of light received by each baby to be measured for periods of up to 300 days. Data can then be downloaded into a computer from which the following can be obtained: total light dose, time-series analysis for any period (i.e. the peaks and troughs and their time sequences). The light monitoring system consists of two light sensors and a storage device or datalogger. The light transducing sensors pass information to the datalogger which partially analyses and stores the light measurements at regular intervals. Once recording has begun, measurement and recording of light levels is continued automatically.

> Page 5 - 6 > 06-07-95

5.9.1 LIGHT SENSORS

Two photodiode sensors measure the light exposure in two ways: illuminance and irradiance. The S1133 diode has a spectral response close to that of the human eye and thus measures illuminance. The S1133-01 diode measures irradiance in the range of 420-720 mn. [Note: this range omits the highly damaging violet and sometimes even ultraviolet components of the fluorescent lamp spectrum against which preemies do not yet have the protections of the adult eye.]

The sensors are attached to the input channels by a double shielded coaxial cable with the ground and measurement connection both being shielded. The two sensors are mounted together in a single silicone block (1.5 cm x 1.5 cm). The sensors are then placed as close to the baby's eye as practical. In effect this mans the sensors will be external to the goggles, but inside any shield around the baby such as the incubator or head box. Thus the sensors will receive the identical light dose to the baby.

5.9.2 DATALOGGER

The storage device, or datalogger, is a box measuring 15.5 cm x 9.25 cm x 4.5 cm. This box contains a two channel microprocessor controlling measurement rates, data storage, and a data retrieval system. Each channel of the microprocessor has a 16K storage capacity and receives data from one of the light sensing photodiodes. The signals from the photodiodes, operating in logarithmic configuration, are digitized and stored in sequential memory locations: even locations in channel 1 and odd locations in channel 2. The digitized and stored light values range from 0-255. Sampling occurs every 8 seconds; every 75 readings are averaged; when the averaged value is stored, the previous 75 readings are deleted.

[Note : This averaging deletes the peaks which are bound to cause more light damage than low lighting conditions.  The only data that are relevant to the alleged subject of the study are thus automatically deleted.]

Thus the illuminance and irradiance levels are monitored every eight seconds and these readings are averaged every 10 minutes and stored in memory. The datalogger has already been used successfully in clinical settings both in the UK and US.8.9

5.9.2.1 Connections

The datalogger has connections to the light sensors and an RS232 port:

Sensor leads are connected into two jack-plugs (one 3.5 mm and one 2.5 mm). The differences in plug sizes make it impossible to incorrectly attach the jacks.

A single RS232 serial port enables the datalogger to be connected to a computer for transfer and safe storage of the light readings at the end of the recording period. Use of the RS232 port means that no special input boards are required for data transfer between recorder and computer (see section 5.10.2.4.d).

5.9.2.2 Digital Display

On the base of the datalogger is a digital display or clock which indicates that the datalogger is working. Once recording has begun, it will display an arbitrary n between 1-99999; this number will change about once every 8 seconds. If the display is not activated, the datalogger is not working. The rate at which the number changes indicates the recording rate.

[Note: The reading of the monitor is thus not subject to visual verification and comparison with actual lighting conditions.  This instant check is needed to notice gross measuring errors from machines that go haywire. In fact, shortly before the end of the almost two-year trial, Dr. Reynolds informed the National Eye Institute that all the data so acquired were false and useless.  See his Progress Report of February 1, 1997.]

5.9.2.3 Push Button Switch

A push-button switch is located in a circular hole beside the program selection switch. Once datalogging has begun, this button/switch should not be pressed again. To guard against accidental repeated activation, this button is located in a relatively inaccessible position.

5.9-2.4 Program Selection

The datalogger contains 8 inbuilt computer programs. Using the switch below the digital display, they can be accessed by the operator. To avoid inadvertent alteration through movement, contact, etc., the switch is recessed and controlled by a screwdriver.

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